A Trial of Intratumoral Injections of SD-101 in Combination With Pembrolizumab in Patients With Metastatic Melanoma or Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Sponsor
Dynavax Technologies Corporation (Industry)
Overall Status
Terminated
CT.gov ID
NCT02521870
Collaborator
Merck Sharp & Dohme LLC (Industry)
241
47
9
55
5.1
0.1
Study Details
Study Description
Brief Summary
This is a phase 1b/2, open-label, multicenter trial designed to evaluate the safety, tolerability, biologic activity, and preliminary efficacy of intratumoral SD-101 injections in combination with intravenous pembrolizumab in patients with metastatic melanoma or recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
This study will be conducted in 2 phases. Phase 1 evaluates SD-101 given in combination with pembrolizumab in melanoma populations (anti-PD-1/L1 naïve and anti-PD-1/L1 experienced with progressive disease) in up to 4 Dose Escalation cohorts to identify a recommended Phase 2 dose (RP2D) to be evaluated in up to 4 Dose Expansion cohorts in Phase 2. Phase 2 also includes up to 4 Dose Expansion cohorts of patients with HNSCC (anti-PD-1/L1 naïve and anti-PD-1/L1 experienced with progressive disease).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
241 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1b/2, Open-label, Multicenter, Dose-escalation and Expansion Trial of Intratumoral SD-101 in Combination With Pembrolizumab in Patients With Metastatic Melanoma or Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (SYNERGY-001)
Study Start Date
:
Sep 1, 2015
Actual Primary Completion Date
:
Apr 1, 2020
Actual Study Completion Date
:
Apr 1, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Dose Escalation Phase 1b Determine the maximum tolerated dose (MTD) of escalating doses of SD-101(1) administered in combination with pembrolizumab in patients with melanoma (anti-PD-1/L1 therapy naïve and experienced patients with progressive disease). |
Drug: SD-101(1)
SD-101 administered intratumorally at escalating doses (up to 11 doses).
Biological: Pembrolizumab
Pembrolizumab administered intravenously, 200 mg Q3W for two years (up to 35 doses).
|
| Experimental: Dose Expansion Phase 2 (Cohort 1) Determine the safety and efficacy of SD-101(2) and pembrolizumab in anti-PD-1/L1 therapy naïve patients with recurrent or metastatic melanoma. |
Drug: SD-101(2)
Dose Q1W for 4 weeks followed by dose Q3W for 7 weeks, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 weeks (up to 22 total doses).
Biological: Pembrolizumab
Pembrolizumab administered intravenously, 200mg Q3W for two years (up to 35 doses).
|
| Experimental: Dose Expansion Phase 2 (Cohort 2) Determine the safety and efficacy of SD-101(2) and pembrolizumab in anti-PD-1/L1 therapy progressing patients with recurrent or metastatic melanoma. |
Drug: SD-101(2)
Dose Q1W for 4 weeks followed by dose Q3W for 7 weeks, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 weeks (up to 22 total doses).
Biological: Pembrolizumab
Pembrolizumab administered intravenously, 200mg Q3W for two years (up to 35 doses).
|
| Experimental: Dose Expansion Phase 2 (Cohort 3) Determine the safety and efficacy of SD-101(2) and pembrolizumab in anti-PD-1/L1 therapy naïve patients with recurrent head and neck squamous cell carcinoma. |
Drug: SD-101(2)
Dose Q1W for 4 weeks followed by dose Q3W for 7 weeks, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 weeks (up to 22 total doses).
Biological: Pembrolizumab
Pembrolizumab administered intravenously, 200mg Q3W for two years (up to 35 doses).
|
| Experimental: Dose Expansion Phase 2 (Cohort 4) Determine the safety and efficacy of SD-101(2) and pembrolizumab in anti-PD-1/L1 therapy progressing patients with recurrent head and neck squamous cell carcinoma. |
Drug: SD-101(2)
Dose Q1W for 4 weeks followed by dose Q3W for 7 weeks, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 weeks (up to 22 total doses).
Biological: Pembrolizumab
Pembrolizumab administered intravenously, 200mg Q3W for two years (up to 35 doses).
|
| Experimental: Dose Expansion Phase 2 (Cohort 5) Determine the safety and efficacy of SD-101(3) and pembrolizumab in anti-PD-1/L1 therapy naïve patients with recurrent or metastatic melanoma. |
Biological: SD-101(3)
Dose Q1W for 4 weeks followed by dose Q3W for 16 additional weeks (up to 20 total doses).
Biological: Pembrolizumab
Pembrolizumab administered intravenously, 200mg Q3W for two years (up to 35 doses).
|
| Experimental: Dose Expansion Phase 2 (Cohort 6) Determine the safety and efficacy of SD-101(3) and pembrolizumab in anti-PD-1/L1 therapy naïve patients with recurrent head and neck squamous cell carcinoma. |
Biological: SD-101(3)
Dose Q1W for 4 weeks followed by dose Q3W for 16 additional weeks (up to 20 total doses).
Biological: Pembrolizumab
Pembrolizumab administered intravenously, 200mg Q3W for two years (up to 35 doses).
|
| Experimental: Dose Expansion Phase 2 (Cohort 7) Determine the safety and efficacy of SD-101(3) and pembrolizumab in anti-PD-1/L1 therapy refractory or resistant patients with recurrent head and neck squamous cell carcinoma. |
Biological: SD-101(3)
Dose Q1W for 4 weeks followed by dose Q3W for 16 additional weeks (up to 20 total doses).
Biological: Pembrolizumab
Pembrolizumab administered intravenously, 200mg Q3W for two years (up to 35 doses).
|
| Experimental: Dose Expansion Phase 2 (Cohort 8) Determine the safety and efficacy of SD-101(3) and pembrolizumab in anti-PD-1/L1 therapy refractory or resistant patients with recurrent or metastatic melanoma. |
Biological: SD-101(3)
Dose Q1W for 4 weeks followed by dose Q3W for 16 additional weeks (up to 20 total doses).
Biological: Pembrolizumab
Pembrolizumab administered intravenously, 200mg Q3W for two years (up to 35 doses).
|
Outcome Measures
Primary Outcome Measures
- Phase 1 Dose Escalation Only - Number of Participants With DLTs [Day 1 through Day 29]
Dose-limiting toxicities (DLTs) are defined per protocol as specific AEs occurring from the time of the first injection (Day 1) through Day 29.
- Phase 1 Dose Escalation and Phase 2 Dose Expansion - Overall Response Rate (ORR) by Analysis Group [Day 1 through Day 743]
Overall response rate (ORR) by analysis group based on investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 was evaluated from Baseline (Day 1) through Day 743 or End of Study (EOS).
Secondary Outcome Measures
- Phase 1 Dose Escalation and Phase 2 Dose Expansion - Time to Objective Response by Analysis Group [Day 1 through Day 743]
Time to objective response by analysis group based on investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 was evaluated from Baseline (Day 1) through Day 743 or End of Study (EOS).
- Phase 1 Dose Escalation and Phase 2 Dose Expansion - Duration of Response by Analysis Group [Day 1 through Day 743]
Duration of response by analysis group based on investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 was evaluated from Baseline (Day 1) through Day 743 or End of Study (EOS).
- Phase 1 Dose Escalation and Phase 2 Dose Expansion - Disease Control Rate (DCR) by Analysis Group [Day 1 through Day 743]
Disease Control Rate (DCR) by analysis group based on investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 was evaluated from Baseline (Day 1) through Day 743 or End of Study (EOS).
- Phase 1 Dose Escalation and Phase 2 Dose Expansion - Progression-Free Survival Rate by Analysis Group [Day 1 through Day 743]
Progression-Free Survival (PFS) rate by analysis group based on investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 was evaluated from Baseline (Day 1) through Day 743 or End of Study (EOS).
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
[Inclusion Criteria (Phase 1 and Phase 2)]
-
Willing and able to provide written informed consent for the trial
-
Aged 18 years and older
-
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
-
Patient must have adequate organ function as indicated by the following laboratory values:
-
Hematological:
-
Absolute neutrophil count (ANC) ≥ 1,500 /mcL
-
Platelet count ≥ 100,000 /mcL
-
Hemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L
- Renal:
-
Serum creatinine ≤ 1.5 × upper limit of normal (ULN) OR
-
Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≥ 60 mL/min for subject with creatinine levels > 1.5 × institutional ULN
- Hepatic:
-
Serum total bilirubin:
-
≤ 1.5 × ULN OR
-
< 3 × ULN for persons with Gilbert's syndrome OR
-
Direct bilirubin ≤ ULN for patients with total bilirubin levels > 1.5 × ULN
-
Aspartate transaminase (AST) and alanine transaminase (ALT) (also known as serum glutamic oxaloacetic transaminase and serum glutamic pyruvic transaminase)
-
≤ 2.5 × ULN OR
-
≤ 5 × ULN for patients with liver metastases
- Coagulation:
-
International normalized ratio or prothrombin time (PT) ≤ 1.5 × ULN unless patient is receiving anticoagulant therapy, and as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
-
Activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN unless patient is receiving anticoagulant therapy, and as long as PT or PTT is within therapeutic range of intended use of anticoagulants
-
Have provided 2 tissue biopsy samples taken of the target lesion (Lesion A) as a single biopsy split into 2 samples or 2 separate biopsies that meet the minimal sample size requirement per the study laboratory manual. One sample is for determining PD-L1 expression level by immunohistochemistry and can be an archival sample of the anticipated target lesion that has been collected within 3 months of screening. The other sample is for RNA expression profiling and must be a fresh biopsy.
-
Life expectancy of at least 6 months
-
Female patients of childbearing potential, as defined in Section 5.2.1, must have a negative urine or serum pregnancy test within 72 hours prior to taking the first dose of trial treatment. If the urine test is positive or cannot be confirmed as negative then a serum test is required which must be negative for the patient to enroll. Women of childbearing potential (WOCBP) must be willing to use 2 medically acceptable methods of contraceptive from Day 1 through 120 days after the last dose of trial treatment. The 2 medically acceptable birth control methods can be either 2 barrier methods or a barrier method plus a hormonal method to prevent pregnancy. The following are considered adequate barrier methods of contraception: diaphragm, condom (by the partner), copper intrauterine device, sponge, or spermicide as per local regulations or guidelines. Appropriate hormonal contraceptives will include any registered and marketed contraceptive agent that contains an estrogen and/or a progestational agent (including oral, subcutaneous, intrauterine, or intramuscular agents).
Male patients of reproductive potential, as described in Section 5.2.1, must agree to use an adequate method of contraception from Day 1 through 120 days after the last dose of trial treatment.
Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the patient.
[Inclusion Criteria (Phase 1 only: Melanoma)]
-
Histologically or cytologically confirmed unresectable or metastatic (stage IV) melanoma
-
For Phase 1 Escalation Cohorts 1-4, must have at least 1 lesion that qualifies as a target lesion per RECIST v1.1 except for the minimum measurement of 10 mm in diameter for superficial lesions, is easily accessible (palpable or can be visualized by ultrasound), and is amenable to multiple intratumoral injections. If superficial, the target lesion must be documented photographically.
[Inclusion Criteria (Phase 2 only: Melanoma)]
-
Histologically or cytologically confirmed recurrent or unresectable or metastatic (stage IV) melanoma
-
Must have at least 2 lesions that qualify as a target lesion per RECIST v1.1, and 1 of the qualifying lesions must be easily accessible (palpable or can be visualized by ultrasound) and amenable to multiple intratumoral injections. The target lesion should be of sufficient size such that the required tumor biopsies do not significantly affect tumor assessment per RECIST v1.1. If superficial, the target lesion must measure at least 10 mm in diameter, be measured by calipers, and be documented photographically. Tumor lesions situated in a previously irradiated area, or in an area subjected to other loco-regional therapy, are usually not considered measurable unless there has been demonstrated progression in the lesion. Approval from the Medical Monitor is required to inject a previously radiated lesion.
-
Expansion Cohort 2: Must have documented PD per RECIST v1.1 on a prior treatment regimen containing an anti-PD-1/L1 drug (see Appendix 6 for definition of PD per RECIST v1.1)
-
Expansion Cohort 8: Must have all of the following:
-
Received at least 2 doses of an anti-PD-1/L1 therapy
-
PD occurred within 3 months after last dose of anti-PD-1/L1 therapy
-
Documented PD per RECIST v.1.1, which has been confirmed by a second assessment at least 4 weeks from the date of the first documented PD, in the absence of rapid clinical progression
[Inclusion Criteria (Phase 2 only: HNSCC)]
-
Histologically or cytologically confirmed recurrent or metastatic HNSCC that could not be treated with curative intent
-
Must have at least 1 lesion that qualifies as a target lesion per RECIST v1.1, and which must be easily accessible (palpable or can be visualized by ultrasound) and amenable to multiple intratumoral injections. The target lesion should be of sufficient size such that the required tumor biopsies do not significantly affect tumor assessment per RECIST v1.1. Tumor lesions situated in a previously irradiated area, or in an area subjected to other loco-regional therapy, are usually not considered measurable unless there has been demonstrated progression in the lesion. Approval from the Medical Monitor is required to inject a previously radiated lesion.
-
Expansion Cohort 4: Must have documented confirmed PD per RECIST v1.1 on a prior treatment regimen containing an anti-PD-1/L1 drug (see Appendix 6 for definition of PD per RECIST v1.1)
-
Expansion Cohort 7: Must have all of the following:
-
Received at least 2 doses of an anti-PD-1/L1 therapy, where the last dose of anti-PD-1/L1 therapy was within 6 months of study enrollment (Day 1)
-
Refractory response, ie, PD occurred within 3 months duration of the start of treatment on anti-PD-1/L1 therapy; OR resistant response, ie, PD occurred beyond 3 months duration of treatment on anti-PD-1/L1 therapy and within 6 months after the last dose of treatment on anti-PD-1/L1 therapy
-
Documented PD per RECIST v.1.1, which has been confirmed by a second assessment at least 4 weeks from the date of the first documented PD, in the absence of rapid clinical progression
[Exclusion Criteria (Phase 1 and Phase 2)]
-
Received systemic chemotherapy or biological cancer therapy (except anti-PD-1/L1 therapy) within 3 weeks prior to study enrollment
-
Received prior radiotherapy within 2 weeks of start of study therapy. A shorter washout period may be permitted after approval by the Medical Monitor.
-
Received small molecule inhibitor targeted therapy, such as tyrosine kinase inhibitors, within 2 weeks prior to study enrollment
-
Has not recovered to CTCAE Grade 1 or better from the AEs due to cancer therapeutics prior to study enrollment
NOTE: Patients with ≤ Grade 2 neuropathy or ≤ Grade 2 alopecia or Grade 2 AEs that qualify as Grade 2 due to replacement hormonal or steroid therapy are exceptions to this criterion and may qualify for the study with approval by a Dynavax Medical Monitor.
If a patient received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to enrollment.
-
Received a transfusion of blood products (including platelets or red blood cells) or colony-stimulating factors (including G-CSF, GM-CSF or recombinant erythropoietin) within 4 weeks prior to study enrollment
-
Is expected to require any other form of anti-cancer therapy while in the trial
-
Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy (including immune modulators or systemic corticosteroids) within 7 days prior to study enrollment
-
Positive for active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection as determined by laboratory tests for HBsAg, anti-HBc, and anti-HBs; anti-HCV; and anti-HIV -1/2, respectively
-
History of or current uveal or ocular or mucosal melanoma
-
Active infection including cytomegalovirus
-
Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial through 120 days after the last dose of trial treatment
-
Active autoimmune disease requiring systemic treatment in the past 2 years or a disease that requires immunosuppressive medication including systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, or autoimmune thrombocytopenia. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
-
Current pneumonitis or history of (non-infectious) pneumonitis that required steroids
-
An immune-related AE from a previous immunotherapeutic agent that has not resolved to Grade 1 or less prior to study enrollment. The exception is a Grade 2 AE which qualifies as Grade 2 due to replacement steroid therapy which may be allowed with approval by a Dynavax Medical Monitor.
-
Known active central nervous system metastases or carcinomatous meningitis
NOTE: Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging [using the identical imaging modality for each assessment, either MRI or CT scan] for at least 4 weeks prior to the first dose of trial treatment and with any neurologic symptoms returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
-
Use of any investigational agent within the last 28 days prior to study enrollment
-
Has received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted.
-
Any other significant medical or psychiatric condition, laboratory abnormality, or difficulty complying with protocol requirements that may increase the risk associated with trial participation or trial drug administration that may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the patient inappropriate for this trial
-
History of sensitivity to any component of SD-101 or hypersensitivity reaction to treatment with a monoclonal antibody and/or any of its excipients
-
Any known additional malignancy that is progressing or requires active treatment. Exceptions are cutaneous melanoma or HNSCC under study per protocol, or basal cell carcinoma of the skin, squamous cell carcinoma of the skin or in situ cervical cancer that has undergone potentially curative therapy.
[Exclusion Criteria (Phase 2, Melanoma Expansion Cohorts 1 and 5 only)]
-
Melanoma considered resectable with curative intent
-
Prior therapy with an anti-PD-1/L1 agent
-
Has severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients
[Exclusion Criteria (Phase 2, Melanoma Expansion Cohorts 2 and 8 only)]
-
Melanoma considered resectable with curative intent
-
Any prior combination therapy involving agents given by intratumoral injection that target the innate immune pathway or system such as oncolytic viral or microbial therapy (eg, T-VEC [talimogene laherparepvec]), toll-like receptors (TLR) agonists, STING or RIG-1 and an anti-PD-1/L1 inhibitor
[Exclusion Criteria (Phase 2, HNSCC Expansion Cohorts 3 and 6 only)]
-
HNSCC considered resectable with curative intent
-
Prior therapy with an anti-PD-1/L1 agent
-
Require anticoagulation therapy
[Exclusion Criteria (Phase 2, HNSCC Expansion Cohorts 4 and 7 only)]
-
HNSCC considered resectable with curative intent
-
Any prior combination therapy involving agents given by intratumoral injection that target the innate immune pathway or system such as oncolytic viral or microbial therapy (eg, T-VEC), TLR agonists, STING or RIG-1 and an anti-PD-1/L1 inhibitor
-
Require treatment on anticoagulation therapy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama School of Medicine | Birmingham | Alabama | United States | 35294 |
| 2 | University of Alabama | Birmingham | Alabama | United States | 35294 |
| 3 | University of Arizona Cancer Center | Tucson | Arizona | United States | 85721 |
| 4 | University of California, Los Angeles | Los Angeles | California | United States | 90095 |
| 5 | Stanford Hospitals and Clinics | Palo Alto | California | United States | 94305 |
| 6 | University of California, San Diego | San Diego | California | United States | 92093 |
| 7 | University of California San Francisco | San Francisco | California | United States | 94158 |
| 8 | University of Colorado | Aurora | Colorado | United States | 80045 |
| 9 | Mount Sinai Comprehensive Cancer Center | Miami Beach | Florida | United States | 33140 |
| 10 | Georgia Cancer Center - Northside Hospital Central Research Department | Atlanta | Georgia | United States | 30341 |
| 11 | Northwestern University | Chicago | Illinois | United States | 60208 |
| 12 | University of Iowa Healthcare | Iowa City | Iowa | United States | 52242 |
| 13 | University of Michigan | Ann Arbor | Michigan | United States | 48109 |
| 14 | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | United States | 48201 |
| 15 | University of Minnesota Masonic Cancer Center | Minneapolis | Minnesota | United States | 55455 |
| 16 | Nebraska Methodist Hospital | Omaha | Nebraska | United States | 68130 |
| 17 | Atlantic Health | Morristown | New Jersey | United States | 07962 |
| 18 | Roswell Park Cancer Institute | Buffalo | New York | United States | 14263 |
| 19 | Levine Cancer Institute | Charlotte | North Carolina | United States | 28204 |
| 20 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
| 21 | The Christ Hospital | Cincinnati | Ohio | United States | 45219 |
| 22 | University Hospitals Cleveland Medical Center - Seidman Cancer center | Cleveland | Ohio | United States | 44106 |
| 23 | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | United States | 73104 |
| 24 | Providence Portland Medical Center | Portland | Oregon | United States | 97213 |
| 25 | Penn State Hershey Medical Center | Hershey | Pennsylvania | United States | 17033 |
| 26 | Medical University of South Carolina | Charleston | South Carolina | United States | 29425 |
| 27 | Mary Crowley Cancer Research Center | Dallas | Texas | United States | 75230 |
| 28 | University of Utah Health Care - Huntsman Cancer institute | Salt Lake City | Utah | United States | 84112 |
| 29 | Inova Schar Cancer Institute | Fairfax | Virginia | United States | 22031 |
| 30 | West Virginia University | Morgantown | West Virginia | United States | 26506 |
| 31 | The Tweed Hospital | Tweed Heads | New South Wales | Australia | 2485 |
| 32 | Liverpool Hospital | Westmead | New South Wales | Australia | 2170 |
| 33 | Melanoma Institute | Wollstonecraft | New South Wales | Australia | 2065 |
| 34 | Adelaide Cancer Centre - Ashford Cancer Centre | Kurralta Park | South Australia | Australia | 5037 |
| 35 | Hollywood Private Hospital / Affinity Research | Nedlands | Western Australia | Australia | |
| 36 | Charité - Universitätsmedizin Berlin | Berlin | Germany | ||
| 37 | Klinikum BuxtehudeDermato-Onkologie Studienzentrale | Buxtehude | Germany | ||
| 38 | Uniklinikum Dresden Klinik und Poliklinik für Dermatologie | Dresden | Germany | ||
| 39 | Universitätshautklinik Frankfurt | Frankfurt | Germany | ||
| 40 | Medizinische Hochschule Hannover | Hannover | Germany | ||
| 41 | HNO-Universitätsklinik Jena | Jena | Germany | ||
| 42 | Universitätshautklinik Magdeburg | Magdeburg | Germany | ||
| 43 | Universitätsklinikum Regensburg | Regensburg | Germany | ||
| 44 | Universitätsklinikum Tübingen | Tubingen | Germany | ||
| 45 | Auckland City Hospital | Auckland | New Zealand | 1023 | |
| 46 | Christchurch Hospital | Christchurch | New Zealand | 4710 | |
| 47 | Waikato Hospital | Hamilton | New Zealand | 3204 |
Sponsors and Collaborators
- Dynavax Technologies Corporation
- Merck Sharp & Dohme LLC
Investigators
- Principal Investigator: Antoni Ribas, MD, UCLA School of Medicine (Melanoma)
- Principal Investigator: Ezra Cohen, MD, UCSD Moores Cancer Center (HNSCC)
- Principal Investigator: Thomas Tüting, MD, University Hospital Magdeburg
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Dynavax Technologies Corporation
ClinicalTrials.gov Identifier:
NCT02521870
Other Study ID Numbers:
- DV3-MEL-01
- Keynote 184
- SYNERGY-001
First Posted:
Aug 13, 2015
Last Update Posted:
Aug 3, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by Dynavax Technologies Corporation
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | SD-101 1 mg | SD-101 2 mg | SD-101 4 mg | SD-101 8 mg | SD-101 8 mg in Anti-PD-1/L1-Naïve Melanoma | SD-101 8 mg in Anti-PD-1/L1-Experienced Melanoma | SD-101 8 mg in Anti-PD-1/L1-Naïve HNSCC | SD-101 8 mg in Anti-PD-1/L1-Experienced HNSCC | SD-101 2 mg in Anti-PD-1/L1-Naïve Melanoma | SD-101 2 mg in Anti-PD-1/L1-Naïve HNSCC | SD-101 2 mg in Anti-PD-1/L1 Refractory or Resistant HNSCC | SD-101 2 mg in Anti-PD-1/L1 Refractory or Resistant Melanoma |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Dose Escalation Cohort 4: Participants were administered SD-101 1 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. | Dose Escalation Cohort 1: Participants were administered SD-101 2 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. | Dose Escalation Cohort 2: Participants were administered SD-101 4 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. | Dose Escalation Cohort 3: Participants were administered SD-101 8 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. | Dose Expansion Cohort 1: Participants with melanoma who are anti-PD-1/L1-naïve were administered SD-101 8 mg intratumorally starting on Day 22 dose Q1W for 4 weeks followed by dose Q3W for 7 doses, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 doses (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. | Dose Expansion Cohort 2: Participants with melanoma who are anti-PD-1/L1-experienced were administered SD-101 8 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 7 doses, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 doses (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. | Dose Expansion Cohort 3: Participants with HNSCC who are anti-PD-1/L1-naïve were administered SD-101 8 mg intratumorally starting on Day 22 dose Q1W for 4 weeks followed by dose Q3W for 7 doses, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 doses (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. | Dose Expansion Cohort 4: Participants with HNSCC who are anti-PD-1/L1-experienced were administered SD-101 8 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 7 doses, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 doses (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. | Dose Expansion Cohort 5: Participants with melanoma who are anti-PD-1/L1-naïve were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 doses (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. | Dose Expansion Cohort 6: Participants with HNSCC who are anti-PD-1/L1-naïve were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 doses (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. | Dose Expansion Cohort 7: Participants with HNSCC who are anti-PD-1/L1 refractory or resistant were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 doses (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. | Dose Expansion Cohort 8: Participants with melanoma who are anti-PD-1/L1 refractory or resistant were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 doses (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. |
| Period Title: Phase 1: Dose Escalation | ||||||||||||
| STARTED | 6 | 5 | 5 | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Completed SD-101 Treatment (up to 11 Doses) | 3 | 3 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| COMPLETED | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| NOT COMPLETED | 5 | 4 | 4 | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Period Title: Phase 1: Dose Escalation | ||||||||||||
| STARTED | 0 | 0 | 0 | 0 | 57 | 25 | 23 | 9 | 24 | 28 | 23 | 30 |
| Completed SD-101 Treatment (up to 11 Doses) | 0 | 0 | 0 | 0 | 25 | 7 | 3 | 2 | 9 | 5 | 1 | 11 |
| Completed SD-101 Treatment Cycle 2 (up to 22 Doses) | 0 | 0 | 0 | 0 | 7 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| COMPLETED | 0 | 0 | 0 | 0 | 5 | 0 | 0 | 0 | 2 | 0 | 0 | 0 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 52 | 25 | 23 | 9 | 22 | 28 | 23 | 30 |
Baseline Characteristics
| Arm/Group Title | Melanoma Anti-PD-1/L1 Naïve SD-101 2 mg | Melanoma Anti-PD-1/L1 Naïve SD-101 8 mg | Melanoma Anti-PD-1/L1 Experienced SD-101 2 mg | Melanoma Anti-PD-1/L1 Experienced SD-101 8 mg | HNSCC Anti-PD-1/L1 Naïve SD-101 2 mg | HNSCC Anti-PD-1/L1 Naïve SD-101 8 mg | HNSCC Anti-PD-1/L1 Experienced SD-101 2 mg | HNSCC Anti-PD-1/L1 Experienced SD-101 8 mg | Total |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 1 and Cohort 5. | Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 1. | Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 2 and Cohort 8. | Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 2. | Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 3 and Cohort 6. | Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 3. | Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 4 and Cohort 7. | Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 4. | Total of all reporting groups |
| Overall Participants | 45 | 41 | 31 | 30 | 28 | 23 | 23 | 9 | 230 |
| Age (Count of Participants) | |||||||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
16
35.6%
|
18
43.9%
|
13
41.9%
|
17
56.7%
|
16
57.1%
|
10
43.5%
|
15
65.2%
|
4
44.4%
|
109
47.4%
|
| >=65 years |
29
64.4%
|
23
56.1%
|
18
58.1%
|
13
43.3%
|
12
42.9%
|
13
56.5%
|
8
34.8%
|
5
55.6%
|
121
52.6%
|
| Age (years) [Mean (Standard Deviation) ] | |||||||||
| Mean (Standard Deviation) [years] |
66.2
(13.34)
|
65.3
(12.44)
|
65.6
(12.99)
|
62.4
(15.25)
|
62.6
(10.66)
|
67.2
(9.59)
|
61.0
(12.94)
|
65.2
(12.35)
|
64.4
(12.45)
|
| Sex: Female, Male (Count of Participants) | |||||||||
| Female |
13
28.9%
|
14
34.1%
|
10
32.3%
|
7
23.3%
|
9
32.1%
|
2
8.7%
|
8
34.8%
|
1
11.1%
|
64
27.8%
|
| Male |
32
71.1%
|
27
65.9%
|
21
67.7%
|
23
76.7%
|
19
67.9%
|
21
91.3%
|
15
65.2%
|
8
88.9%
|
166
72.2%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||||||||
| Hispanic or Latino |
0
0%
|
2
4.9%
|
1
3.2%
|
4
13.3%
|
0
0%
|
0
0%
|
2
8.7%
|
1
11.1%
|
10
4.3%
|
| Not Hispanic or Latino |
43
95.6%
|
37
90.2%
|
28
90.3%
|
26
86.7%
|
28
100%
|
22
95.7%
|
20
87%
|
8
88.9%
|
212
92.2%
|
| Unknown or Not Reported |
2
4.4%
|
2
4.9%
|
2
6.5%
|
0
0%
|
0
0%
|
1
4.3%
|
1
4.3%
|
0
0%
|
8
3.5%
|
| Race/Ethnicity, Customized (Count of Participants) | |||||||||
| White |
44
97.8%
|
41
100%
|
30
96.8%
|
25
83.3%
|
24
85.7%
|
20
87%
|
19
82.6%
|
9
100%
|
212
92.2%
|
| Black or African American |
1
2.2%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
2
8.7%
|
2
8.7%
|
0
0%
|
5
2.2%
|
| Asian |
0
0%
|
0
0%
|
1
3.2%
|
1
3.3%
|
2
7.1%
|
1
4.3%
|
2
8.7%
|
0
0%
|
7
3%
|
| Other |
0
0%
|
0
0%
|
0
0%
|
4
13.3%
|
2
7.1%
|
0
0%
|
0
0%
|
0
0%
|
6
2.6%
|
| ECOG Performance Status (Count of Participants) | |||||||||
| 0 |
28
62.2%
|
30
73.2%
|
19
61.3%
|
16
53.3%
|
5
17.9%
|
6
26.1%
|
4
17.4%
|
2
22.2%
|
110
47.8%
|
| 1 |
17
37.8%
|
11
26.8%
|
12
38.7%
|
14
46.7%
|
23
82.1%
|
17
73.9%
|
19
82.6%
|
7
77.8%
|
120
52.2%
|
| PDL1 Expression (Count of Participants) | |||||||||
| Positive |
21
46.7%
|
13
31.7%
|
9
29%
|
13
43.3%
|
14
50%
|
15
65.2%
|
4
17.4%
|
7
77.8%
|
96
41.7%
|
| Negative |
14
31.1%
|
15
36.6%
|
8
25.8%
|
11
36.7%
|
2
7.1%
|
4
17.4%
|
5
21.7%
|
1
11.1%
|
60
26.1%
|
| Unknown |
10
22.2%
|
13
31.7%
|
14
45.2%
|
6
20%
|
12
42.9%
|
4
17.4%
|
14
60.9%
|
1
11.1%
|
74
32.2%
|
Outcome Measures
| Title | Phase 1 Dose Escalation Only - Number of Participants With DLTs |
|---|---|
| Description | Dose-limiting toxicities (DLTs) are defined per protocol as specific AEs occurring from the time of the first injection (Day 1) through Day 29. |
| Time Frame | Day 1 through Day 29 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety population is defined as comprising of participants who received at least 1 dose of SD-101. |
| Arm/Group Title | SD-101 1 mg | SD-101 2 mg | SD-101 4 mg | SD-101 8 mg | SD-101 8 mg in Anti-PD-1/L1-Naïve Melanoma | SD-101 8 mg in Anti-PD-1/L1-Experienced Melanoma | SD-101 8 mg in Anti-PD-1/L1-Naïve HNSCC | SD-101 8 mg in Anti-PD-1/L1-Experienced HNSCC | SD-101 2 mg in Anti-PD-1/L1-Naïve Melanoma | SD-101 2 mg in Anti-PD-1/L1-Naïve HNSCC | SD-101 2 mg in Anti-PD-1/L1 Refractory or Resistant HNSCC | SD-101 2 mg in Anti-PD-1/L1 Refractory or Resistant Melanoma |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Dose Escalation Cohort 4: Participants were administered SD-101 1 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. | Dose Escalation Cohort 1: Participants were administered SD-101 2 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. | Dose Escalation Cohort 2: Participants were administered SD-101 4 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. | Dose Escalation Cohort 3: Participants were administered SD-101 8 mg intratumorally as 4 weekly doses followed by 1 dose Q3W for 7 additional doses. Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. | Dose Expansion Cohort 1: Participants with melanoma who are anti-PD-1/L1-naïve were administered SD-101 8 mg intratumorally starting on Day 22 dose Q1W for 4 weeks followed by dose Q3W for 7 weeks, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 weeks (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. | Dose Expansion Cohort 2: Participants with melanoma who are anti-PD-1/L1-experienced were administered SD-101 8 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 7 weeks, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 weeks (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. | Dose Expansion Cohort 3: Participants with HNSCC who are anti-PD-1/L1-naïve were administered SD-101 8 mg intratumorally starting on Day 22 dose Q1W for 4 weeks followed by dose Q3W for 7 weeks, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 weeks (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. | Dose Expansion Cohort 4: Participants with HNSCC who are anti-PD-1/L1-experienced were administered SD-101 8 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 7 weeks, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 weeks (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. | Dose Expansion Cohort 5: Participants with melanoma who are anti-PD-1/L1-naïve were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 weeks (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. | Dose Expansion Cohort 6: Participants with HNSCC who are anti-PD-1/L1-naïve were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 weeks (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. | Dose Expansion Cohort 7: Participants with HNSCC who are anti-PD-1/L1 refractory or resistant were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 weeks (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. | Dose Expansion Cohort 8: Participants with melanoma who are anti-PD-1/L1 refractory or resistant were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 weeks (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. |
| Measure Participants | 6 | 5 | 5 | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
| Title | Phase 1 Dose Escalation and Phase 2 Dose Expansion - Overall Response Rate (ORR) by Analysis Group |
|---|---|
| Description | Overall response rate (ORR) by analysis group based on investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 was evaluated from Baseline (Day 1) through Day 743 or End of Study (EOS). |
| Time Frame | Day 1 through Day 743 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The intent-to-treat (ITT) population comprises of all participants who were enrolled in the study. |
| Arm/Group Title | Melanoma Anti-PD-1/L1 Naïve SD-101 2 mg | Melanoma Anti-PD-1/L1 Naïve SD-101 8 mg | Melanoma Anti-PD-1/L1 Experienced SD-101 2 mg | Melanoma Anti-PD-1/L1 Experienced SD-101 8 mg | HNSCC Anti-PD-1/L1 Naïve SD-101 2 mg | HNSCC Anti-PD-1/L1 Naïve SD-101 8 mg | HNSCC Anti-PD-1/L1 Experienced SD-101 2 mg | HNSCC Anti-PD-1/L1 Experienced SD-101 8 mg |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 1 and Cohort 5. | Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 1. | Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 2 and Cohort 8. | Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 2. | Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 3 and Cohort 6. | Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 3. | Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 4 and Cohort 7. | Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 4. |
| Measure Participants | 45 | 41 | 31 | 30 | 28 | 23 | 23 | 9 |
| Complete Response |
9
20%
|
4
9.8%
|
0
0%
|
1
3.3%
|
2
7.1%
|
0
0%
|
0
0%
|
1
11.1%
|
| Partial Response |
25
55.6%
|
16
39%
|
7
22.6%
|
3
10%
|
4
14.3%
|
6
26.1%
|
2
8.7%
|
0
0%
|
| Stable Disease |
2
4.4%
|
8
19.5%
|
8
25.8%
|
8
26.7%
|
7
25%
|
5
21.7%
|
3
13%
|
2
22.2%
|
| Progressive Disease |
5
11.1%
|
8
19.5%
|
12
38.7%
|
11
36.7%
|
10
35.7%
|
9
39.1%
|
10
43.5%
|
4
44.4%
|
| Not Evaluable |
4
8.9%
|
5
12.2%
|
4
12.9%
|
7
23.3%
|
5
17.9%
|
3
13%
|
8
34.8%
|
2
22.2%
|
| Title | Phase 1 Dose Escalation and Phase 2 Dose Expansion - Time to Objective Response by Analysis Group |
|---|---|
| Description | Time to objective response by analysis group based on investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 was evaluated from Baseline (Day 1) through Day 743 or End of Study (EOS). |
| Time Frame | Day 1 through Day 743 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The intent-to-treat (ITT) population comprises of all participants who were enrolled in the study. This subset of participants analyzed comprises of participants with objective response. |
| Arm/Group Title | Melanoma Anti-PD-1/L1 Naïve SD-101 2 mg | Melanoma Anti-PD-1/L1 Naïve SD-101 8 mg | Melanoma Anti-PD-1/L1 Experienced SD-101 2 mg | Melanoma Anti-PD-1/L1 Experienced SD-101 8 mg | HNSCC Anti-PD-1/L1 Naïve SD-101 2 mg | HNSCC Anti-PD-1/L1 Naïve SD-101 8 mg | HNSCC Anti-PD-1/L1 Experienced SD-101 2 mg | HNSCC Anti-PD-1/L1 Experienced SD-101 8 mg |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 1 and Cohort 5. | Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 1. | Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 2 and Cohort 8. | Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 2. | Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 3 and Cohort 6. | Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 3. | Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 4 and Cohort 7. | Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 4. |
| Measure Participants | 34 | 20 | 7 | 4 | 6 | 6 | 2 | 1 |
| Mean (Standard Deviation) [months] |
3.2
(1.6)
|
4.1
(2.96)
|
5.1
(3.06)
|
4.3
(2.98)
|
2.3
(.92)
|
2.4
(0.87)
|
2.7
(1.09)
|
2.1
(0)
|
| Title | Phase 1 Dose Escalation and Phase 2 Dose Expansion - Duration of Response by Analysis Group |
|---|---|
| Description | Duration of response by analysis group based on investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 was evaluated from Baseline (Day 1) through Day 743 or End of Study (EOS). |
| Time Frame | Day 1 through Day 743 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The intent-to-treat (ITT) population comprises of all participants who were enrolled in the study. This subset of participants analyzed comprises of participants with objective response. |
| Arm/Group Title | Melanoma Anti-PD-1/L1 Naïve SD-101 2 mg | Melanoma Anti-PD-1/L1 Naïve SD-101 8 mg | Melanoma Anti-PD-1/L1 Experienced SD-101 2 mg | Melanoma Anti-PD-1/L1 Experienced SD-101 8 mg | HNSCC Anti-PD-1/L1 Naïve SD-101 2 mg | HNSCC Anti-PD-1/L1 Naïve SD-101 8 mg | HNSCC Anti-PD-1/L1 Experienced SD-101 2 mg | HNSCC Anti-PD-1/L1 Experienced SD-101 8 mg |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 1 and Cohort 5. | Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 1. | Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 2 and Cohort 8. | Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 2. | Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 3 and Cohort 6. | Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 3. | Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 4 and Cohort 7. | Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 4. |
| Measure Participants | 34 | 20 | 7 | 4 | 6 | 6 | 2 | 1 |
| Mean (Standard Deviation) [months] |
11.1
(6.42)
|
11.7
(5.96)
|
4.6
(6.57)
|
7.6
(7.28)
|
5.9
(4.93)
|
6.3
(3.96)
|
2.1
(0.07)
|
8.1
(0)
|
| Title | Phase 1 Dose Escalation and Phase 2 Dose Expansion - Disease Control Rate (DCR) by Analysis Group |
|---|---|
| Description | Disease Control Rate (DCR) by analysis group based on investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 was evaluated from Baseline (Day 1) through Day 743 or End of Study (EOS). |
| Time Frame | Day 1 through Day 743 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The intent-to-treat (ITT) population comprises of all participants who were enrolled in the study. |
| Arm/Group Title | Melanoma Anti-PD-1/L1 Naïve SD-101 2 mg | Melanoma Anti-PD-1/L1 Naïve SD-101 8 mg | Melanoma Anti-PD-1/L1 Experienced SD-101 2 mg | Melanoma Anti-PD-1/L1 Experienced SD-101 8 mg | HNSCC Anti-PD-1/L1 Naïve SD-101 2 mg | HNSCC Anti-PD-1/L1 Naïve SD-101 8 mg | HNSCC Anti-PD-1/L1 Experienced SD-101 2 mg | HNSCC Anti-PD-1/L1 Experienced SD-101 8 mg |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 1 and Cohort 5. | Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 1. | Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 2 and Cohort 8. | Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 2. | Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 3 and Cohort 6. | Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 3. | Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 4 and Cohort 7. | Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 4. |
| Measure Participants | 45 | 41 | 31 | 30 | 28 | 23 | 23 | 9 |
| Count of Participants [Participants] |
36
80%
|
28
68.3%
|
15
48.4%
|
12
40%
|
13
46.4%
|
11
47.8%
|
5
21.7%
|
3
33.3%
|
| Title | Phase 1 Dose Escalation and Phase 2 Dose Expansion - Progression-Free Survival Rate by Analysis Group |
|---|---|
| Description | Progression-Free Survival (PFS) rate by analysis group based on investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 was evaluated from Baseline (Day 1) through Day 743 or End of Study (EOS). |
| Time Frame | Day 1 through Day 743 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The intent-to-treat (ITT) population comprises of all participants who were enrolled in the study. |
| Arm/Group Title | Melanoma Anti-PD-1/L1 Naïve SD-101 2 mg | Melanoma Anti-PD-1/L1 Naïve SD-101 8 mg | Melanoma Anti-PD-1/L1 Experienced SD-101 2 mg | Melanoma Anti-PD-1/L1 Experienced SD-101 8 mg | HNSCC Anti-PD-1/L1 Naïve SD-101 2 mg | HNSCC Anti-PD-1/L1 Naïve SD-101 8 mg | HNSCC Anti-PD-1/L1 Experienced SD-101 2 mg | HNSCC Anti-PD-1/L1 Experienced SD-101 8 mg |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 1 and Cohort 5. | Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 1. | Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 2 and Cohort 8. | Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 2. | Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 3 and Cohort 6. | Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 3. | Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 4 and Cohort 7. | Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 4. |
| Measure Participants | 45 | 41 | 31 | 30 | 28 | 23 | 23 | 9 |
| 3 months |
85.7
190.4%
|
71.9
175.4%
|
46.7
150.6%
|
48
160%
|
46.4
165.7%
|
43.5
189.1%
|
31.6
137.4%
|
37.5
416.7%
|
| 6 months |
78.4
174.2%
|
63.3
154.4%
|
33
106.5%
|
24
80%
|
26.5
94.6%
|
17.4
75.7%
|
0
0%
|
25
277.8%
|
| 9 months |
70.8
157.3%
|
60.4
147.3%
|
21.4
69%
|
14.4
48%
|
21.2
75.7%
|
17.4
75.7%
|
0
0%
|
12.5
138.9%
|
| 12 months |
70.8
157.3%
|
53.7
131%
|
21.4
69%
|
9.6
32%
|
15.9
56.8%
|
8.7
37.8%
|
00
0%
|
0
0%
|
| 15 months |
65.1
144.7%
|
49.9
121.7%
|
0
0%
|
9.6
32%
|
15.9
56.8%
|
4.3
18.7%
|
00
0%
|
0
0%
|
| 18 months |
61.5
136.7%
|
40.3
98.3%
|
0
0%
|
9.6
32%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| 21 months |
61.5
136.7%
|
40.3
98.3%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| 24 months |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Adverse Events
| Time Frame | From informed consent through Day 743 | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||||||
| Arm/Group Title | Melanoma Anti-PD-1/L1 Naïve SD-101 2 mg | Melanoma Anti-PD-1/L1 Naïve SD-101 8 mg | Melanoma Anti-PD-1/L1 Experienced SD-101 2 mg | Melanoma Anti-PD-1/L1 Experienced SD-101 8 mg | HNSCC Anti-PD-1/L1 Naïve SD-101 2 mg | HNSCC Anti-PD-1/L1 Naïve SD-101 8 mg | HNSCC Anti-PD-1/L1 Experienced SD-101 2 mg | HNSCC Anti-PD-1/L1 Experienced SD-101 8 mg | ||||||||
| Arm/Group Description | Some of the Phase 1 dose escalation cohorts and the 8 Phase 2 dose expansion cohorts were rearranged as analysis groups for analyses to assess the Phase 2 objectives as specified by the statistical analysis plan, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. Results for Phase 2 objectives, using combined Phases 1 and 2 data, are presented by 2mg/lesion and 8mg/lesion doses. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 5. | Some of the Phase 1 dose escalation cohorts and the 8 Phase 2 dose expansion cohorts were rearranged as analysis groups for analyses to assess the Phase 2 objectives as specified by the statistical analysis plan, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. Results for Phase 2 objectives, using combined Phases 1 and 2 data, are presented by 2mg/lesion and 8mg/lesion doses. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 1. | Some of the Phase 1 dose escalation cohorts and the 8 Phase 2 dose expansion cohorts were rearranged as analysis groups for analyses to assess the Phase 2 objectives as specified by the statistical analysis plan, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. Results for Phase 2 objectives, using combined Phases 1 and 2 data, are presented by 2mg/lesion and 8mg/lesion doses. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 8. | Some of the Phase 1 dose escalation cohorts and the 8 Phase 2 dose expansion cohorts were rearranged as analysis groups for analyses to assess the Phase 2 objectives as specified by the statistical analysis plan, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. Results for Phase 2 objectives, using combined Phases 1 and 2 data, are presented by 2mg/lesion and 8mg/lesion doses. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 2. | Some of the Phase 1 dose escalation cohorts and the 8 Phase 2 dose expansion cohorts were rearranged as analysis groups for analyses to assess the Phase 2 objectives as specified by the statistical analysis plan, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. Results for Phase 2 objectives, using combined Phases 1 and 2 data, are presented by 2mg/lesion and 8mg/lesion doses. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 6. | Some of the Phase 1 dose escalation cohorts and the 8 Phase 2 dose expansion cohorts were rearranged as analysis groups for analyses to assess the Phase 2 objectives as specified by the statistical analysis plan, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. Results for Phase 2 objectives, using combined Phases 1 and 2 data, are presented by 2mg/lesion and 8mg/lesion doses. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 3. | Some of the Phase 1 dose escalation cohorts and the 8 Phase 2 dose expansion cohorts were rearranged as analysis groups for analyses to assess the Phase 2 objectives as specified by the statistical analysis plan, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. Results for Phase 2 objectives, using combined Phases 1 and 2 data, are presented by 2mg/lesion and 8mg/lesion doses. The participants in this analysis group include participants in Phase 2 Dose Expansion and Cohort 7. | Some of the Phase 1 dose escalation cohorts and the 8 Phase 2 dose expansion cohorts were rearranged as analysis groups for analyses to assess the Phase 2 objectives as specified by the statistical analysis plan, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. Results for Phase 2 objectives, using combined Phases 1 and 2 data, are presented by 2mg/lesion and 8mg/lesion doses. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 4. | ||||||||
All Cause Mortality |
||||||||||||||||
| Melanoma Anti-PD-1/L1 Naïve SD-101 2 mg | Melanoma Anti-PD-1/L1 Naïve SD-101 8 mg | Melanoma Anti-PD-1/L1 Experienced SD-101 2 mg | Melanoma Anti-PD-1/L1 Experienced SD-101 8 mg | HNSCC Anti-PD-1/L1 Naïve SD-101 2 mg | HNSCC Anti-PD-1/L1 Naïve SD-101 8 mg | HNSCC Anti-PD-1/L1 Experienced SD-101 2 mg | HNSCC Anti-PD-1/L1 Experienced SD-101 8 mg | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/44 (4.5%) | 3/39 (7.7%) | 5/31 (16.1%) | 7/30 (23.3%) | 6/27 (22.2%) | 13/23 (56.5%) | 7/23 (30.4%) | 3/9 (33.3%) | ||||||||
Serious Adverse Events |
||||||||||||||||
| Melanoma Anti-PD-1/L1 Naïve SD-101 2 mg | Melanoma Anti-PD-1/L1 Naïve SD-101 8 mg | Melanoma Anti-PD-1/L1 Experienced SD-101 2 mg | Melanoma Anti-PD-1/L1 Experienced SD-101 8 mg | HNSCC Anti-PD-1/L1 Naïve SD-101 2 mg | HNSCC Anti-PD-1/L1 Naïve SD-101 8 mg | HNSCC Anti-PD-1/L1 Experienced SD-101 2 mg | HNSCC Anti-PD-1/L1 Experienced SD-101 8 mg | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 15/44 (34.1%) | 17/39 (43.6%) | 6/31 (19.4%) | 9/30 (30%) | 8/27 (29.6%) | 5/23 (21.7%) | 10/23 (43.5%) | 4/9 (44.4%) | ||||||||
| Blood and lymphatic system disorders | ||||||||||||||||
| Anaemia | 1/44 (2.3%) | 0/39 (0%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Eosinophilia | 0/44 (0%) | 1/39 (2.6%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Febrile neutropenia | 1/44 (2.3%) | 0/39 (0%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Iron deficiency anaemia | 0/44 (0%) | 0/39 (0%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 1/9 (11.1%) | ||||||||
| Thrombocytopenia | 0/44 (0%) | 0/39 (0%) | 0/31 (0%) | 0/30 (0%) | 1/27 (3.7%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Cardiac disorders | ||||||||||||||||
| Angina pectoris | 0/44 (0%) | 0/39 (0%) | 1/31 (3.2%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Aortic valve stenosis | 0/44 (0%) | 0/39 (0%) | 0/31 (0%) | 1/30 (3.3%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Atrial fibrillation | 0/44 (0%) | 0/39 (0%) | 0/31 (0%) | 1/30 (3.3%) | 0/27 (0%) | 1/23 (4.3%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Atrial flutter | 0/44 (0%) | 0/39 (0%) | 0/31 (0%) | 1/30 (3.3%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Atrioventricular block complete | 0/44 (0%) | 0/39 (0%) | 0/31 (0%) | 1/30 (3.3%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Autoimmune myocarditis | 0/44 (0%) | 1/39 (2.6%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Cardiac failure | 0/44 (0%) | 0/39 (0%) | 0/31 (0%) | 1/30 (3.3%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Mitral valve stenosis | 0/44 (0%) | 0/39 (0%) | 0/31 (0%) | 1/30 (3.3%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Pericardial effusion | 0/44 (0%) | 0/39 (0%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 1/23 (4.3%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Pulseless electrical activity | 0/44 (0%) | 0/39 (0%) | 0/31 (0%) | 0/30 (0%) | 1/27 (3.7%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Endocrine disorders | ||||||||||||||||
| Hypophysitis | 1/44 (2.3%) | 0/39 (0%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Inappropriate antidiuretic hormone secretion | 0/44 (0%) | 0/39 (0%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 1/23 (4.3%) | 0/9 (0%) | ||||||||
| Eye disorders | ||||||||||||||||
| Autoimmune retinopathy | 0/44 (0%) | 1/39 (2.6%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Gastrointestinal disorders | ||||||||||||||||
| Constipation | 0/44 (0%) | 0/39 (0%) | 1/31 (3.2%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Diarrhoea | 1/44 (2.3%) | 0/39 (0%) | 0/31 (0%) | 1/30 (3.3%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Intussusception | 0/44 (0%) | 0/39 (0%) | 1/31 (3.2%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Lower gastrointestinal haemorrhage | 0/44 (0%) | 0/39 (0%) | 0/31 (0%) | 1/30 (3.3%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Mouth haemorrhage | 0/44 (0%) | 0/39 (0%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 1/23 (4.3%) | 0/9 (0%) | ||||||||
| Nausea | 0/44 (0%) | 0/39 (0%) | 0/31 (0%) | 1/30 (3.3%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Pancreatitis | 1/44 (2.3%) | 0/39 (0%) | 0/31 (0%) | 1/30 (3.3%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Upper gastrointestinal haemorrhage | 1/44 (2.3%) | 0/39 (0%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Vomiting | 0/44 (0%) | 0/39 (0%) | 1/31 (3.2%) | 2/30 (6.7%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| General disorders | ||||||||||||||||
| Asthenia | 0/44 (0%) | 0/39 (0%) | 1/31 (3.2%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Generalised oedema | 0/44 (0%) | 0/39 (0%) | 0/31 (0%) | 1/30 (3.3%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Influenza like illness | 0/44 (0%) | 1/39 (2.6%) | 0/31 (0%) | 1/30 (3.3%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Localised oedema | 0/44 (0%) | 0/39 (0%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 1/23 (4.3%) | 0/9 (0%) | ||||||||
| Oedema peripheral | 0/44 (0%) | 1/39 (2.6%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Pyrexia | 1/44 (2.3%) | 0/39 (0%) | 2/31 (6.5%) | 1/30 (3.3%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Systemic inflammatory response syndrome | 0/44 (0%) | 0/39 (0%) | 0/31 (0%) | 1/30 (3.3%) | 1/27 (3.7%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Hepatobiliary disorders | ||||||||||||||||
| Autoimmune hepatitis | 0/44 (0%) | 1/39 (2.6%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Bile duct stone | 0/44 (0%) | 0/39 (0%) | 0/31 (0%) | 1/30 (3.3%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Immune system disorders | ||||||||||||||||
| Contrast media allergy | 0/44 (0%) | 1/39 (2.6%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Infections and infestations | ||||||||||||||||
| Abscess | 0/44 (0%) | 0/39 (0%) | 0/31 (0%) | 0/30 (0%) | 1/27 (3.7%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Cellulitis | 2/44 (4.5%) | 0/39 (0%) | 0/31 (0%) | 0/30 (0%) | 1/27 (3.7%) | 0/23 (0%) | 0/23 (0%) | 1/9 (11.1%) | ||||||||
| Clostridium difficile colitis | 0/44 (0%) | 1/39 (2.6%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Erysipelas | 0/44 (0%) | 0/39 (0%) | 1/31 (3.2%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Gastroenteritis | 1/44 (2.3%) | 0/39 (0%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Influenza | 0/44 (0%) | 1/39 (2.6%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Meningitis aseptic | 0/44 (0%) | 1/39 (2.6%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Osteomyelitis | 0/44 (0%) | 0/39 (0%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 1/23 (4.3%) | 0/9 (0%) | ||||||||
| Pneumonia | 0/44 (0%) | 1/39 (2.6%) | 1/31 (3.2%) | 3/30 (10%) | 2/27 (7.4%) | 1/23 (4.3%) | 1/23 (4.3%) | 0/9 (0%) | ||||||||
| Sepsis | 2/44 (4.5%) | 0/39 (0%) | 0/31 (0%) | 0/30 (0%) | 2/27 (7.4%) | 1/23 (4.3%) | 1/23 (4.3%) | 0/9 (0%) | ||||||||
| Septic shock | 0/44 (0%) | 0/39 (0%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 1/23 (4.3%) | 0/9 (0%) | ||||||||
| Skin infection | 1/44 (2.3%) | 0/39 (0%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Soft tissue infection | 0/44 (0%) | 1/39 (2.6%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Streptococcal infection | 0/44 (0%) | 1/39 (2.6%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Urinary tract infection | 0/44 (0%) | 1/39 (2.6%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Urosepsis | 0/44 (0%) | 1/39 (2.6%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Injury, poisoning and procedural complications | ||||||||||||||||
| Cervical vertebral fracture | 0/44 (0%) | 0/39 (0%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 1/23 (4.3%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Fall | 0/44 (0%) | 1/39 (2.6%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 1/23 (4.3%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Humerus fracture | 1/44 (2.3%) | 0/39 (0%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Infusion related reaction | 0/44 (0%) | 0/39 (0%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 1/23 (4.3%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Investigations | ||||||||||||||||
| Alanine aminotransferase increased | 0/44 (0%) | 1/39 (2.6%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Aspartate aminotransferase increased | 0/44 (0%) | 1/39 (2.6%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Blood creatine phosphokinase increased | 0/44 (0%) | 0/39 (0%) | 0/31 (0%) | 1/30 (3.3%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Blood creatinine increased | 1/44 (2.3%) | 0/39 (0%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Metabolism and nutrition disorders | ||||||||||||||||
| Dehydration | 0/44 (0%) | 3/39 (7.7%) | 0/31 (0%) | 1/30 (3.3%) | 1/27 (3.7%) | 1/23 (4.3%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Failure to thrive | 0/44 (0%) | 0/39 (0%) | 0/31 (0%) | 0/30 (0%) | 1/27 (3.7%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Fluid overload | 0/44 (0%) | 0/39 (0%) | 0/31 (0%) | 1/30 (3.3%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Hyponatraemia | 0/44 (0%) | 1/39 (2.6%) | 1/31 (3.2%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Malnutrition | 0/44 (0%) | 0/39 (0%) | 0/31 (0%) | 0/30 (0%) | 1/27 (3.7%) | 0/23 (0%) | 2/23 (8.7%) | 0/9 (0%) | ||||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||||
| Muscular weakness | 0/44 (0%) | 1/39 (2.6%) | 0/31 (0%) | 1/30 (3.3%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Musculoskeletal chest pain | 0/44 (0%) | 0/39 (0%) | 0/31 (0%) | 1/30 (3.3%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Myositis | 0/44 (0%) | 1/39 (2.6%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||||
| Basal cell carcinoma | 1/44 (2.3%) | 0/39 (0%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Infected neoplasm | 0/44 (0%) | 0/39 (0%) | 0/31 (0%) | 1/30 (3.3%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 1/9 (11.1%) | ||||||||
| Squamous cell carcinoma | 1/44 (2.3%) | 1/39 (2.6%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Tumour haemorrhage | 0/44 (0%) | 0/39 (0%) | 0/31 (0%) | 0/30 (0%) | 2/27 (7.4%) | 0/23 (0%) | 1/23 (4.3%) | 0/9 (0%) | ||||||||
| Nervous system disorders | ||||||||||||||||
| Cerebrovascular accident | 1/44 (2.3%) | 0/39 (0%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Embolic stroke | 1/44 (2.3%) | 0/39 (0%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Headache | 1/44 (2.3%) | 0/39 (0%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Hepatic encephalopathy | 0/44 (0%) | 1/39 (2.6%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Ischaemic stroke | 0/44 (0%) | 0/39 (0%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 1/9 (11.1%) | ||||||||
| Metabolic encephalopathy | 0/44 (0%) | 1/39 (2.6%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Myasthenia gravis | 0/44 (0%) | 1/39 (2.6%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Parkinson's disease | 1/44 (2.3%) | 0/39 (0%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Seizure | 0/44 (0%) | 1/39 (2.6%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Syncope | 1/44 (2.3%) | 0/39 (0%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 1/23 (4.3%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Psychiatric disorders | ||||||||||||||||
| Mental status changes | 0/44 (0%) | 0/39 (0%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 1/23 (4.3%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Violence-related symptom | 0/44 (0%) | 0/39 (0%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 1/23 (4.3%) | 0/9 (0%) | ||||||||
| Renal and urinary disorders | ||||||||||||||||
| Acute kidney injury | 0/44 (0%) | 1/39 (2.6%) | 0/31 (0%) | 1/30 (3.3%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Nephrolithiasis | 0/44 (0%) | 1/39 (2.6%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Urinary tract obstruction | 0/44 (0%) | 1/39 (2.6%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||
| Bronchial hyperreactivity | 1/44 (2.3%) | 0/39 (0%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Chronic obstructive pulmonary disease | 0/44 (0%) | 0/39 (0%) | 1/31 (3.2%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Cough | 1/44 (2.3%) | 0/39 (0%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Dyspnoea | 0/44 (0%) | 0/39 (0%) | 0/31 (0%) | 0/30 (0%) | 1/27 (3.7%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Haemoptysis | 0/44 (0%) | 0/39 (0%) | 0/31 (0%) | 0/30 (0%) | 1/27 (3.7%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Hypoxia | 1/44 (2.3%) | 0/39 (0%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Pleural effusion | 1/44 (2.3%) | 0/39 (0%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Pneumonia aspiration | 0/44 (0%) | 0/39 (0%) | 0/31 (0%) | 0/30 (0%) | 1/27 (3.7%) | 0/23 (0%) | 1/23 (4.3%) | 0/9 (0%) | ||||||||
| Pneumonitis | 0/44 (0%) | 1/39 (2.6%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Pneumothorax | 0/44 (0%) | 0/39 (0%) | 0/31 (0%) | 1/30 (3.3%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Pulmonary embolism | 0/44 (0%) | 2/39 (5.1%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Respiratory depression | 0/44 (0%) | 0/39 (0%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 1/9 (11.1%) | ||||||||
| Respiratory failure | 0/44 (0%) | 0/39 (0%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 1/9 (11.1%) | ||||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||||
| Angioedema | 0/44 (0%) | 0/39 (0%) | 0/31 (0%) | 1/30 (3.3%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Vascular disorders | ||||||||||||||||
| Aortic aneurysm | 0/44 (0%) | 1/39 (2.6%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Arterial rupture | 0/44 (0%) | 0/39 (0%) | 0/31 (0%) | 0/30 (0%) | 1/27 (3.7%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Deep vein thrombosis | 0/44 (0%) | 1/39 (2.6%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Hypotension | 0/44 (0%) | 2/39 (5.1%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Orthostatic hypotension | 0/44 (0%) | 0/39 (0%) | 0/31 (0%) | 0/30 (0%) | 1/27 (3.7%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||||
| Melanoma Anti-PD-1/L1 Naïve SD-101 2 mg | Melanoma Anti-PD-1/L1 Naïve SD-101 8 mg | Melanoma Anti-PD-1/L1 Experienced SD-101 2 mg | Melanoma Anti-PD-1/L1 Experienced SD-101 8 mg | HNSCC Anti-PD-1/L1 Naïve SD-101 2 mg | HNSCC Anti-PD-1/L1 Naïve SD-101 8 mg | HNSCC Anti-PD-1/L1 Experienced SD-101 2 mg | HNSCC Anti-PD-1/L1 Experienced SD-101 8 mg | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 44/44 (100%) | 39/39 (100%) | 31/31 (100%) | 30/30 (100%) | 25/27 (92.6%) | 23/23 (100%) | 22/23 (95.7%) | 9/9 (100%) | ||||||||
| Blood and lymphatic system disorders | ||||||||||||||||
| Anaemia | 7/44 (15.9%) | 10/39 (25.6%) | 4/31 (12.9%) | 4/30 (13.3%) | 4/27 (14.8%) | 5/23 (21.7%) | 3/23 (13%) | 2/9 (22.2%) | ||||||||
| Neutropenia | 1/44 (2.3%) | 2/39 (5.1%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Thrombocytopenia | 0/44 (0%) | 0/39 (0%) | 0/31 (0%) | 0/30 (0%) | 1/27 (3.7%) | 2/23 (8.7%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Cardiac disorders | ||||||||||||||||
| Sinus tachycardia | 0/44 (0%) | 0/39 (0%) | 1/31 (3.2%) | 1/30 (3.3%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Endocrine disorders | ||||||||||||||||
| Hypothyroidism | 11/44 (25%) | 3/39 (7.7%) | 1/31 (3.2%) | 1/30 (3.3%) | 2/27 (7.4%) | 2/23 (8.7%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Eye disorders | ||||||||||||||||
| Dry eye | 1/44 (2.3%) | 1/39 (2.6%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Vision blurred | 0/44 (0%) | 0/39 (0%) | 1/31 (3.2%) | 1/30 (3.3%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Gastrointestinal disorders | ||||||||||||||||
| Abdominal pain | 5/44 (11.4%) | 4/39 (10.3%) | 2/31 (6.5%) | 1/30 (3.3%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Constipation | 8/44 (18.2%) | 3/39 (7.7%) | 2/31 (6.5%) | 6/30 (20%) | 4/27 (14.8%) | 4/23 (17.4%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Diarrhoea | 21/44 (47.7%) | 11/39 (28.2%) | 6/31 (19.4%) | 7/30 (23.3%) | 2/27 (7.4%) | 7/23 (30.4%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Dry mouth | 2/44 (4.5%) | 3/39 (7.7%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Dyspepsia | 0/44 (0%) | 0/39 (0%) | 1/31 (3.2%) | 1/30 (3.3%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Dysphagia | 1/44 (2.3%) | 2/39 (5.1%) | 0/31 (0%) | 0/30 (0%) | 5/27 (18.5%) | 6/23 (26.1%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Nausea | 13/44 (29.5%) | 15/39 (38.5%) | 9/31 (29%) | 10/30 (33.3%) | 8/27 (29.6%) | 8/23 (34.8%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Stomatitis | 1/44 (2.3%) | 2/39 (5.1%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Vomiting | 6/44 (13.6%) | 6/39 (15.4%) | 6/31 (19.4%) | 6/30 (20%) | 5/27 (18.5%) | 3/23 (13%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| General disorders | ||||||||||||||||
| Asthenia | 2/44 (4.5%) | 4/39 (10.3%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Chest pain | 1/44 (2.3%) | 1/39 (2.6%) | 0/31 (0%) | 0/30 (0%) | 1/27 (3.7%) | 1/23 (4.3%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Chills | 19/44 (43.2%) | 20/39 (51.3%) | 6/31 (19.4%) | 16/30 (53.3%) | 3/27 (11.1%) | 10/23 (43.5%) | 2/23 (8.7%) | 1/9 (11.1%) | ||||||||
| Face oedema | 1/44 (2.3%) | 1/39 (2.6%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Fatigue | 33/44 (75%) | 31/39 (79.5%) | 13/31 (41.9%) | 22/30 (73.3%) | 15/27 (55.6%) | 17/23 (73.9%) | 7/23 (30.4%) | 5/9 (55.6%) | ||||||||
| Gait disturbance | 1/44 (2.3%) | 1/39 (2.6%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Influenza like illness | 13/44 (29.5%) | 7/39 (17.9%) | 10/31 (32.3%) | 4/30 (13.3%) | 2/27 (7.4%) | 2/23 (8.7%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Injection site erythema | 17/44 (38.6%) | 9/39 (23.1%) | 4/31 (12.9%) | 13/30 (43.3%) | 1/27 (3.7%) | 4/23 (17.4%) | 2/23 (8.7%) | 1/9 (11.1%) | ||||||||
| Injection site induration | 1/44 (2.3%) | 3/39 (7.7%) | 1/31 (3.2%) | 1/30 (3.3%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Injection site pain | 11/44 (25%) | 6/39 (15.4%) | 4/31 (12.9%) | 8/30 (26.7%) | 0/27 (0%) | 0/23 (0%) | 2/23 (8.7%) | 1/9 (11.1%) | ||||||||
| Injection site pruritus | 3/44 (6.8%) | 3/39 (7.7%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Injection site reaction | 0/44 (0%) | 0/39 (0%) | 2/31 (6.5%) | 1/30 (3.3%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Injection site swelling | 9/44 (20.5%) | 5/39 (12.8%) | 0/31 (0%) | 0/30 (0%) | 2/27 (7.4%) | 3/23 (13%) | 1/23 (4.3%) | 1/9 (11.1%) | ||||||||
| Malaise | 14/44 (31.8%) | 20/39 (51.3%) | 4/31 (12.9%) | 11/30 (36.7%) | 0/27 (0%) | 0/23 (0%) | 2/23 (8.7%) | 2/9 (22.2%) | ||||||||
| Non-cardiac chest pain | 2/44 (4.5%) | 1/39 (2.6%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Oedema peripheral | 4/44 (9.1%) | 5/39 (12.8%) | 2/31 (6.5%) | 2/30 (6.7%) | 1/27 (3.7%) | 2/23 (8.7%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Pain | 5/44 (11.4%) | 3/39 (7.7%) | 2/31 (6.5%) | 2/30 (6.7%) | 1/27 (3.7%) | 1/23 (4.3%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Pyrexia | 10/44 (22.7%) | 15/39 (38.5%) | 7/31 (22.6%) | 7/30 (23.3%) | 6/27 (22.2%) | 6/23 (26.1%) | 6/23 (26.1%) | 4/9 (44.4%) | ||||||||
| Secretion discharge | 0/44 (0%) | 0/39 (0%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 1/23 (4.3%) | 1/9 (11.1%) | ||||||||
| Infections and infestations | ||||||||||||||||
| Candida infection | 1/44 (2.3%) | 1/39 (2.6%) | 0/31 (0%) | 0/30 (0%) | 2/27 (7.4%) | 2/23 (8.7%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Cellulitis | 5/44 (11.4%) | 3/39 (7.7%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Folliculitis | 1/44 (2.3%) | 1/39 (2.6%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Gastroenteritis viral | 1/44 (2.3%) | 2/39 (5.1%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Lower respiratory tract infection | 0/44 (0%) | 0/39 (0%) | 1/31 (3.2%) | 1/30 (3.3%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Nasopharyngitis | 1/44 (2.3%) | 1/39 (2.6%) | 2/31 (6.5%) | 1/30 (3.3%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Oral candidiasis | 3/44 (6.8%) | 2/39 (5.1%) | 0/31 (0%) | 0/30 (0%) | 1/27 (3.7%) | 1/23 (4.3%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Pneumonia | 0/44 (0%) | 0/39 (0%) | 0/31 (0%) | 0/30 (0%) | 2/27 (7.4%) | 1/23 (4.3%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Sinusitis | 2/44 (4.5%) | 2/39 (5.1%) | 1/31 (3.2%) | 1/30 (3.3%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Skin infection | 3/44 (6.8%) | 1/39 (2.6%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Upper respiratory tract infection | 5/44 (11.4%) | 3/39 (7.7%) | 1/31 (3.2%) | 1/30 (3.3%) | 1/27 (3.7%) | 2/23 (8.7%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Urinary tract infection | 4/44 (9.1%) | 3/39 (7.7%) | 2/31 (6.5%) | 3/30 (10%) | 1/27 (3.7%) | 2/23 (8.7%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Injury, poisoning and procedural complications | ||||||||||||||||
| Fall | 1/44 (2.3%) | 5/39 (12.8%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Investigations | ||||||||||||||||
| Alanine aminotransferase increased | 4/44 (9.1%) | 2/39 (5.1%) | 1/31 (3.2%) | 2/30 (6.7%) | 2/27 (7.4%) | 2/23 (8.7%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Aspartate aminotransferase increased | 6/44 (13.6%) | 5/39 (12.8%) | 2/31 (6.5%) | 4/30 (13.3%) | 2/27 (7.4%) | 1/23 (4.3%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Blood alkaline phosphatase increased | 3/44 (6.8%) | 2/39 (5.1%) | 1/31 (3.2%) | 1/30 (3.3%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Blood bilirubin increased | 1/44 (2.3%) | 5/39 (12.8%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Blood creatinine increased | 7/44 (15.9%) | 8/39 (20.5%) | 0/31 (0%) | 0/30 (0%) | 1/27 (3.7%) | 2/23 (8.7%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Blood lactate dehydrogenase increased | 0/44 (0%) | 0/39 (0%) | 1/31 (3.2%) | 1/30 (3.3%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| C-reactive protein increased | 0/44 (0%) | 0/39 (0%) | 3/31 (9.7%) | 1/30 (3.3%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Gamma-glutamyltransferase increased | 0/44 (0%) | 0/39 (0%) | 1/31 (3.2%) | 1/30 (3.3%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Lymphocyte count decreased | 1/44 (2.3%) | 3/39 (7.7%) | 1/31 (3.2%) | 1/30 (3.3%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Neutrophil count decreased | 2/44 (4.5%) | 2/39 (5.1%) | 1/31 (3.2%) | 3/30 (10%) | 2/27 (7.4%) | 1/23 (4.3%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Platelet count decreased | 3/44 (6.8%) | 4/39 (10.3%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Tri-iodothyronine free decreased | 0/44 (0%) | 0/39 (0%) | 1/31 (3.2%) | 1/30 (3.3%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Weight decreased | 3/44 (6.8%) | 4/39 (10.3%) | 2/31 (6.5%) | 1/30 (3.3%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| White blood cell count decreased | 3/44 (6.8%) | 5/39 (12.8%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Metabolism and nutrition disorders | ||||||||||||||||
| Decreased appetite | 11/44 (25%) | 11/39 (28.2%) | 3/31 (9.7%) | 9/30 (30%) | 3/27 (11.1%) | 3/23 (13%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Dehydration | 4/44 (9.1%) | 4/39 (10.3%) | 0/31 (0%) | 0/30 (0%) | 1/27 (3.7%) | 2/23 (8.7%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Hypercalcaemia | 0/44 (0%) | 0/39 (0%) | 0/31 (0%) | 0/30 (0%) | 2/27 (7.4%) | 2/23 (8.7%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Hyperglycaemia | 2/44 (4.5%) | 1/39 (2.6%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Hyperkalaemia | 0/44 (0%) | 0/39 (0%) | 1/31 (3.2%) | 1/30 (3.3%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Hypoalbuminaemia | 2/44 (4.5%) | 4/39 (10.3%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Hypokalaemia | 2/44 (4.5%) | 4/39 (10.3%) | 2/31 (6.5%) | 1/30 (3.3%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Hypomagnesaemia | 2/44 (4.5%) | 1/39 (2.6%) | 0/31 (0%) | 0/30 (0%) | 1/27 (3.7%) | 1/23 (4.3%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Hyponatraemia | 5/44 (11.4%) | 3/39 (7.7%) | 1/31 (3.2%) | 2/30 (6.7%) | 3/27 (11.1%) | 2/23 (8.7%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Increased appetite | 1/44 (2.3%) | 1/39 (2.6%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Malnutrition | 0/44 (0%) | 0/39 (0%) | 0/31 (0%) | 0/30 (0%) | 1/27 (3.7%) | 1/23 (4.3%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||||
| Arthralgia | 16/44 (36.4%) | 8/39 (20.5%) | 3/31 (9.7%) | 4/30 (13.3%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Back pain | 4/44 (9.1%) | 2/39 (5.1%) | 2/31 (6.5%) | 3/30 (10%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Groin pain | 1/44 (2.3%) | 1/39 (2.6%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Joint swelling | 1/44 (2.3%) | 1/39 (2.6%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Muscular weakness | 2/44 (4.5%) | 4/39 (10.3%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Musculoskeletal pain | 2/44 (4.5%) | 1/39 (2.6%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Myalgia | 18/44 (40.9%) | 17/39 (43.6%) | 2/31 (6.5%) | 16/30 (53.3%) | 1/27 (3.7%) | 9/23 (39.1%) | 1/23 (4.3%) | 2/9 (22.2%) | ||||||||
| Neck pain | 1/44 (2.3%) | 2/39 (5.1%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 2/23 (8.7%) | 2/9 (22.2%) | ||||||||
| Pain in extremity | 4/44 (9.1%) | 4/39 (10.3%) | 1/31 (3.2%) | 1/30 (3.3%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||||
| Tumour haemorrhage | 0/44 (0%) | 0/39 (0%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 1/23 (4.3%) | 1/9 (11.1%) | ||||||||
| Tumour pain | 3/44 (6.8%) | 1/39 (2.6%) | 4/31 (12.9%) | 2/30 (6.7%) | 4/27 (14.8%) | 2/23 (8.7%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Nervous system disorders | ||||||||||||||||
| Dizziness | 7/44 (15.9%) | 5/39 (12.8%) | 3/31 (9.7%) | 4/30 (13.3%) | 5/27 (18.5%) | 1/23 (4.3%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Dysaesthesia | 1/44 (2.3%) | 1/39 (2.6%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Dysgeusia | 2/44 (4.5%) | 1/39 (2.6%) | 1/31 (3.2%) | 2/30 (6.7%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Headache | 23/44 (52.3%) | 25/39 (64.1%) | 9/31 (29%) | 14/30 (46.7%) | 3/27 (11.1%) | 10/23 (43.5%) | 2/23 (8.7%) | 4/9 (44.4%) | ||||||||
| Hypoaesthesia | 2/44 (4.5%) | 1/39 (2.6%) | 1/31 (3.2%) | 2/30 (6.7%) | 0/27 (0%) | 0/23 (0%) | 1/23 (4.3%) | 1/9 (11.1%) | ||||||||
| Memory impairment | 1/44 (2.3%) | 2/39 (5.1%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Paraesthesia | 1/44 (2.3%) | 2/39 (5.1%) | 2/31 (6.5%) | 1/30 (3.3%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Peripheral sensory neuropathy | 1/44 (2.3%) | 1/39 (2.6%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Presyncope | 2/44 (4.5%) | 3/39 (7.7%) | 1/31 (3.2%) | 1/30 (3.3%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Sinus headache | 1/44 (2.3%) | 1/39 (2.6%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Somnolence | 0/44 (0%) | 0/39 (0%) | 0/31 (0%) | 0/30 (0%) | 1/27 (3.7%) | 1/23 (4.3%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Syncope | 0/44 (0%) | 0/39 (0%) | 0/31 (0%) | 0/30 (0%) | 1/27 (3.7%) | 2/23 (8.7%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Tremor | 1/44 (2.3%) | 2/39 (5.1%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Psychiatric disorders | ||||||||||||||||
| Anxiety | 0/44 (0%) | 0/39 (0%) | 0/31 (0%) | 0/30 (0%) | 1/27 (3.7%) | 3/23 (13%) | 1/23 (4.3%) | 2/9 (22.2%) | ||||||||
| Insomnia | 4/44 (9.1%) | 4/39 (10.3%) | 3/31 (9.7%) | 1/30 (3.3%) | 3/27 (11.1%) | 2/23 (8.7%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Renal and urinary disorders | ||||||||||||||||
| Proteinuria | 1/44 (2.3%) | 3/39 (7.7%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||
| Cough | 8/44 (18.2%) | 4/39 (10.3%) | 3/31 (9.7%) | 6/30 (20%) | 3/27 (11.1%) | 2/23 (8.7%) | 1/23 (4.3%) | 2/9 (22.2%) | ||||||||
| Dysphonia | 1/44 (2.3%) | 1/39 (2.6%) | 1/31 (3.2%) | 1/30 (3.3%) | 2/27 (7.4%) | 2/23 (8.7%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Dyspnoea | 5/44 (11.4%) | 9/39 (23.1%) | 6/31 (19.4%) | 4/30 (13.3%) | 0/27 (0%) | 0/23 (0%) | 2/23 (8.7%) | 1/9 (11.1%) | ||||||||
| Epistaxis | 0/44 (0%) | 0/39 (0%) | 1/31 (3.2%) | 1/30 (3.3%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Haemoptysis | 0/44 (0%) | 0/39 (0%) | 0/31 (0%) | 0/30 (0%) | 1/27 (3.7%) | 1/23 (4.3%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Nasal congestion | 1/44 (2.3%) | 1/39 (2.6%) | 2/31 (6.5%) | 3/30 (10%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Oropharyngeal pain | 4/44 (9.1%) | 2/39 (5.1%) | 0/31 (0%) | 0/30 (0%) | 2/27 (7.4%) | 1/23 (4.3%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Pleural effusion | 1/44 (2.3%) | 1/39 (2.6%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Pneumonia aspiration | 0/44 (0%) | 0/39 (0%) | 0/31 (0%) | 0/30 (0%) | 1/27 (3.7%) | 1/23 (4.3%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Pneumonitis | 2/44 (4.5%) | 2/39 (5.1%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Productive cough | 3/44 (6.8%) | 1/39 (2.6%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 1/23 (4.3%) | 1/9 (11.1%) | ||||||||
| Sinus congestion | 3/44 (6.8%) | 1/39 (2.6%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||||
| Alopecia | 1/44 (2.3%) | 1/39 (2.6%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Dermatitis | 1/44 (2.3%) | 1/39 (2.6%) | 1/31 (3.2%) | 2/30 (6.7%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Dermatitis acneiform | 1/44 (2.3%) | 1/39 (2.6%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Dry skin | 1/44 (2.3%) | 1/39 (2.6%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Ecchymosis | 1/44 (2.3%) | 1/39 (2.6%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Erythema | 5/44 (11.4%) | 3/39 (7.7%) | 4/31 (12.9%) | 3/30 (10%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Hyperhidrosis | 3/44 (6.8%) | 1/39 (2.6%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Night sweats | 0/44 (0%) | 0/39 (0%) | 1/31 (3.2%) | 2/30 (6.7%) | 0/27 (0%) | 0/23 (0%) | 1/23 (4.3%) | 1/9 (11.1%) | ||||||||
| Pruritus | 14/44 (31.8%) | 6/39 (15.4%) | 3/31 (9.7%) | 7/30 (23.3%) | 2/27 (7.4%) | 4/23 (17.4%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Rash | 11/44 (25%) | 7/39 (17.9%) | 1/31 (3.2%) | 1/30 (3.3%) | 2/27 (7.4%) | 1/23 (4.3%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Rash erythematous | 1/44 (2.3%) | 4/39 (10.3%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Rash maculo-papular | 5/44 (11.4%) | 5/39 (12.8%) | 3/31 (9.7%) | 3/30 (10%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Rash pruritic | 3/44 (6.8%) | 1/39 (2.6%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Scab | 1/44 (2.3%) | 1/39 (2.6%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Skin hypopigmentation | 1/44 (2.3%) | 3/39 (7.7%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Skin lesion | 1/44 (2.3%) | 1/39 (2.6%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Vitiligo | 5/44 (11.4%) | 4/39 (10.3%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Vascular disorders | ||||||||||||||||
| Flushing | 2/44 (4.5%) | 2/39 (5.1%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Haematoma | 1/44 (2.3%) | 1/39 (2.6%) | 0/31 (0%) | 0/30 (0%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Hypertension | 4/44 (9.1%) | 13/39 (33.3%) | 1/31 (3.2%) | 2/30 (6.7%) | 1/27 (3.7%) | 2/23 (8.7%) | 0/23 (0%) | 0/9 (0%) | ||||||||
| Hypotension | 1/44 (2.3%) | 1/39 (2.6%) | 0/31 (0%) | 0/30 (0%) | 2/27 (7.4%) | 1/23 (4.3%) | 1/23 (4.3%) | 1/9 (11.1%) | ||||||||
| Lymphoedema | 2/44 (4.5%) | 1/39 (2.6%) | 3/31 (9.7%) | 1/30 (3.3%) | 0/27 (0%) | 0/23 (0%) | 0/23 (0%) | 0/9 (0%) | ||||||||
Limitations/Caveats
The sponsor terminated the trial early due to strategic restructuring, including the planned conclusion of clinical oncology development programs and no further sponsoring of the development of SD-101.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Robert Janssen MD \ VP & Chief Medical Officer |
|---|---|
| Organization | Dynavax Technologies, Inc. |
| Phone | 510-665-0414 |
| rjanssen@dynavax.com |
Responsible Party:
Dynavax Technologies Corporation
ClinicalTrials.gov Identifier:
NCT02521870
Other Study ID Numbers:
- DV3-MEL-01
- Keynote 184
- SYNERGY-001
First Posted:
Aug 13, 2015
Last Update Posted:
Aug 3, 2021
Last Verified:
Jul 1, 2021