Safety and Efficacy of MEDI0457 and Durvalumab in Participants With Human Papilloma Virus (HPV) Associated Recurrent/Metastatic Head and Neck Cancer
Sponsor
MedImmune LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT03162224
Collaborator
(none)
35
14
3
44.7
2.5
0.1
Study Details
Study Description
Brief Summary
This is a Phase 1b/2a, open-label, multi-center study to evaluate the safety and tolerability, anti-tumor activity, and immunogenicity of MEDI0457 (also known as INO 3112) a HPV Deoxyribonucleic Acid (DNA) vaccine in combination with durvalumab (also known as MEDI4736) which is a human monoclonal antibody directed against Programmed Death Ligand 1 (PD-L1), which blocks the interaction of PD-L1 with PD-1 and Cluster of differentiation 80 (CD80).
An initial three to 12 participants (Safety Analysis Run-in participants) will be enrolled and assessed for safety before additional participants are enrolled.
The initial safety analysis run-in participants along with an approximate total of 50 participants with human papilloma virus associated recurrent or metastatic head and neck squamous cell cancer (HNSCC) will be enrolled in this study and evaluated also for anti-tumor efficacy to MEDI0457 in combination with durvalumab.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
35 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1b/2a, Multi-Center Open-Label Study to Evaluate the Safety and Efficacy of Combination Treatment With MEDI0457 (INO-3112) and Durvalumab (MEDI4736) in Patients With Recurrent/Metastatic HPV Associated Head and Neck Squamous Cancer
Actual Study Start Date
:
Jun 26, 2017
Actual Primary Completion Date
:
Mar 19, 2021
Actual Study Completion Date
:
Mar 19, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: First-line Recurrent/Metastatic (1L R/M) Platinum Non-refractory Participants with recurrent or metastatic disease and were non-refractory to neoadjuvant/adjuvant platinum based chemotherapy, will receive MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then every 8 weeks (Q8W) and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then every 4 weeks (Q4W) until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurs first. |
Drug: MEDI0457
MEDI0457 7 mg will be administered intramuscularly followed by electroporation (EP) using CELLECTRA®5P device.
Other Names:
Device: CELLECTRA®5P device
MEDI0457 7 mg will be administered intramuscularly followed by EP using CELLECTRA®5P device.
Other Names:
Drug: Durvalumab
Durvalumab will be administered intravenously at a dose of 1500 mg every 4 weeks.
Other Names:
|
| Experimental: 1L R/M Platinum Refractory Participants with R/M disease and were refractory to neoadjuvant/adjuvant platinum based chemotherapy, will receive MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurs first. |
Drug: MEDI0457
MEDI0457 7 mg will be administered intramuscularly followed by electroporation (EP) using CELLECTRA®5P device.
Other Names:
Device: CELLECTRA®5P device
MEDI0457 7 mg will be administered intramuscularly followed by EP using CELLECTRA®5P device.
Other Names:
Drug: Durvalumab
Durvalumab will be administered intravenously at a dose of 1500 mg every 4 weeks.
Other Names:
|
| Experimental: Second-line (2L) + R/M Participants with R/M disease and were treated with 1 or more lines of platinum based chemotherapy, will receive MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurs first. |
Drug: MEDI0457
MEDI0457 7 mg will be administered intramuscularly followed by electroporation (EP) using CELLECTRA®5P device.
Other Names:
Device: CELLECTRA®5P device
MEDI0457 7 mg will be administered intramuscularly followed by EP using CELLECTRA®5P device.
Other Names:
Drug: Durvalumab
Durvalumab will be administered intravenously at a dose of 1500 mg every 4 weeks.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) [Day 1 through 90 days after the last dose of study drug (approximately 45 months)]
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. There will be no updated results for this outcome measures at the time of end of study.
- Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs [Day 1 through 90 days after the last dose of study drug (approximately 45 months)]
Any laboratory abnormality during analysis of hematology, clinical chemistry, thyroid function tests, and urinalysis that was new in onset or worsened in severity or frequency from the baseline condition and required therapeutic intervention or diagnostic tests, led to discontinuation of study treatment, had accompanying or inducing symptoms or signs, or judged by the Investigator as clinically significant was recorded as AE. Participants with abnormal laboratory parameters reported as TEAEs are reported.
- Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs [Day 1 through 90 days after the last dose of study drug (approximately 45 months)]
Participants with ECG abnormalities reported as TEAEs are reported.
- Number of Participants With Abnormal Vital Signs and/or Physical Examination Reported as TEAEs [Day 1 through 90 days after the last dose of study drug (approximately 45 months)]
Vital sign assessment included body temperature, respiration rate, pulse oximetry, blood pressure, heart rate, and weight. Participants with abnormal vital sign and/or abnormal physical examination reported as TEAEs are reported.
- Number of Participants Who Received Any Concomitant Medications During the Study [Day 1 through 90 days after the last dose of study drug (approximately 45 months)]
Participants who received concomitant medications which were ongoing at the start of treatment or started after the study treatment are included.
- Number of Participants With Shift >=3 Changed From Baseline in Eastern Cooperative Oncology Group Performance (ECOG) Status [Day 1 through 90 days after the last dose of study drug (approximately 45 months)]
Participants with shift >=3 changed from baseline in ECOG status are reported. ECOG performance status is used by doctors and researchers to assess how a participant's disease is progressing, assess how the disease affects the daily living activities of the participant and determine appropriate treatment and prognosis. The scores are: 0 = Fully Active, able to carry out all pre-disease performance without restrictions; 1 = Restricted activity but ambulatory and able to carry out light work or work of a sedentary nature; 2 = Ambulatory and capable of self-care but unable to carry out work activities; 3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4 = Completely Disabled, unable to carry out any self-care and totally confined to bed or chair; 5 = Dead.
- Percentage of Participants With Objective Response by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 in Response-evaluable Population [Day 1 through end of study (approximately 45 months)]
The objective response is defined as confirmed complete response (CR) or confirmed partial response (PR) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) guidelines. The CR is defined as disappearance of all target and non-target lesions, no new lesions, and normalization of tumor marker level. The PR is defined as >= 30% decrease in the sum of the diameters of target lesions compared to baseline and no new non-target lesion. A confirmed CR or PR is defined as 2 CRs or 2 PRs that were separated by at least 4 weeks with no evidence of progression or not evaluable response in-between. Percentage of participants with objective response is reported.
Secondary Outcome Measures
- Percentage of Participants With Objective Response by RECIST Version 1.1 in As-treated Population [Day 1 through end of study (approximately 45 months)]
The objective response is defined as confirmed CR or confirmed PR based on RECIST v1.1 guidelines. The CR is defined as disappearance of all target and non-target lesions, no new lesions, and normalization of tumor marker level. The PR is defined as >= 30% decrease in the sum of the diameters of target lesions compared to baseline and no new non-target lesion. A confirmed CR or PR is defined as 2 CRs or 2 PRs that were separated by at least 4 weeks with no evidence of progression or not evaluable response in-between. Percentage of participants with objective response is reported.
- Percentage of Participants With Objective Response by Immune-related RECIST (irRECIST) in Response-evaluable Population [Day 1 through end of study (approximately 45 months)]
The objective response is defined as confirmed CR or confirmed PR based on irRECIST v1.1 guidelines. The irCR is defined as disappearance of all target and non-target lesions, no new lesions, and normalization of tumor marker level. The irPR is defined as >= 50% decrease in the sum of the diameters of target lesions compared to baseline and no new non-target lesion. A confirmed irCR or irPR is defined as 2 irCRs or 2 irPRs that were separated by at least 4 weeks with no evidence of progression or not evaluable response in-between. Percentage of participants with objective response is reported.
- Percentage of Participants With Objective Response by irRECIST in As-treated Population [Day 1 through end of study (approximately 45 months)]
The objective response is defined as confirmed CR or confirmed PR based on irRECIST v1.1 guidelines. The irCR is defined as disappearance of all target and non-target lesions, no new lesions, and normalization of tumor marker level. The irPR is defined as >= 50% decrease in the sum of the diameters of target lesions compared to baseline and no new non-target lesion. A confirmed irCR or irPR is defined as 2 irCRs or 2 irPRs that were separated by at least 4 weeks with no evidence of progression or not evaluable response in-between. Percentage of participants with objective response is reported.
- Disease Control Rate (DCR) at Week 16 by RECIST Version 1.1 in Response-evaluable Population [Week 16]
The DCR is defined percentage of participants with CR, PR, or stable disease (SD) at 16 weeks based on RECIST v1.1 guidelines. A CR is defined as disappearance of all target and non-target lesions, no new lesions, and normalization of tumor marker level. A PR is defined as >= 30% decrease in the sum of longest diameters of target lesions compared to baseline and no new non-target lesion. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression, taking as reference the smallest sum longest diameter since the study treatment started, and persistence of one or more non-target lesion(s) or / and maintenance of tumor marker level above the normal limits.
- DCR at Week 16 by RECIST Version 1.1 in As-treated Population [Week 16]
The DCR is defined percentage of participants with CR, PR, or SD at 16 weeks based on RECIST v1.1 guidelines. A CR is defined as disappearance of all target and non-target lesions, no new lesions, and normalization of tumor marker level. A PR is defined as >= 30% decrease in the sum of longest diameters of target lesions compared to baseline and no new non-target lesion. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression, taking as reference the smallest sum longest diameter since the study treatment started, and persistence of one or more non-target lesion(s) or / and maintenance of tumor marker level above the normal limits.
- Progression Free Survival (PFS) [Day 1 through end of study (approximately 45 months)]
The PFS is defined as the time from the date of start of study treatment until the documentation of disease progression based on RECIST version 1.1 or death due to any cause, whichever occurs first. The progressive disease is defined at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started, the appearance of one or more new lesions, or unequivocal progression of existing non-target lesions. Participants who were not progressed or died at the time of the analysis were censored at the time of the latest date of assessment from their last evaluable RECIST version 1.1 assessment. The PFS was estimated using Kaplan-Meier method.
- Overall Survival (OS) [Day 1 through end of study (approximately 45 months)]
Overall survival is defined as the time from the date of start of study treatment until death due to any cause. Any participant not died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. The OS was estimated using Kaplan-Meier method.
- Number of Participants With Positive Anti-Drug Antibodies (ADA) to Durvalumab [Pre-dose (up to 60 minutes prior to durvalumab administration) on Week 4, Week 8, and Week 16]
Number of participants with positive ADA titer to durvalumab are reported. ADA prevalence is defined as ADA positive at any point (baseline and post-baseline); persistent positive is defined as ADA positive at Week 16, and transient positive is defined as positive at Week 8 but not at Week 16, regardless of baseline positivity.
- Serum Concentrations of Durvalumab [Pre-dose (up to 60 minutes prior to durvalumab administration) on Week 4, Week 8, and Week 16]
Serum concentrations of durvalumab is reported.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Male and female participants 18 years and older
-
Histologically or cytologically confirmed diagnosis of HNSCC associated with HPV by a p16 immunohistochemistry (IHC) assay or HPV-16 or HPV-18 positive by nucleic acid testing.
-
Recurrent or metastatic disease that has been treated with at least one platinum-containing regimen and lacking a curative treatment option.
-
Participants who are platinum ineligible may be enrolled if they have received and failed an approved treatment and lack a treatment option with curative potential.
Exclusion criteria:
-
Any concurrent chemotherapy, immune-mediated therapy or biologic or hormonal therapy for cancer treatment Active or prior documented autoimmune disease with some exceptions.
-
Current or prior use of immunosuppressive medication within 14 days prior to first study dose, with the exception of intranasal and inhaled corticosteroids or systemic corticosteroids at doses not to exceed 10 mg/day of prednisone or equivalent. Steroids as premedication for hypersensitivity reactions due to radiographic contrast agents are allowed.
-
No prior exposure to immune-mediated therapy defined as prior exposure to T-cell and natural killer cell directed therapy (e.g., anti-PD-1, anti-PD-L1, anti-CD137, and anti-CTLA4, etc).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | San Francisco | California | United States | 94115 |
| 2 | Research Site | Orlando | Florida | United States | 32806 |
| 3 | Research Site | Atlanta | Georgia | United States | 30308 |
| 4 | Research Site | Indianapolis | Indiana | United States | 46202 |
| 5 | Research Site | Baltimore | Maryland | United States | 21201 |
| 6 | Research Site | Baltimore | Maryland | United States | 21287 |
| 7 | Research Site | Detroit | Michigan | United States | 48201 |
| 8 | Research Site | Minneapolis | Minnesota | United States | 55414 |
| 9 | Research Site | Saint Louis | Missouri | United States | 63110 |
| 10 | Research Site | Morristown | New Jersey | United States | 07960 |
| 11 | Research Site | Bronx | New York | United States | 10461 |
| 12 | Research Site | Winston-Salem | North Carolina | United States | 27157 |
| 13 | Research Site | Columbus | Ohio | United States | 43210 |
| 14 | Research Site | Philadelphia | Pennsylvania | United States | 19104 |
Sponsors and Collaborators
- MedImmune LLC
Investigators
- Study Director: MedImmune LLC, Study Director
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.Responsible Party:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT03162224
Other Study ID Numbers:
- D8860C00005
First Posted:
May 22, 2017
Last Update Posted:
Aug 25, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by MedImmune LLC
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | The data are reported per the data cut-off (DCO) date of 19Mar2021 and the data after DCO will not be entered into the clinical study database and hence, will not be analyzed. |
| Arm/Group Title | First-line Recurrent/Metastatic (1L R/M) Platinum Non-refractory | 1L R/M Platinum Refractory | Second-line (2L) + R/M |
|---|---|---|---|
| Arm/Group Description | Participants with recurrent or metastatic disease and were non-refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then every 8 weeks (Q8W) and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then every 4 weeks (Q4W) until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first. | Participants with R/M disease and were refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first. | Participants with R/M disease and were treated with 1 or more lines of platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first. |
| Period Title: Overall Study | |||
| STARTED | 15 | 9 | 11 |
| COMPLETED | 4 | 1 | 1 |
| NOT COMPLETED | 11 | 8 | 10 |
Baseline Characteristics
| Arm/Group Title | 1L R/M Platinum Non-refractory | 1L R/M Platinum Refractory | 2L+R/M | Total |
|---|---|---|---|---|
| Arm/Group Description | Participants with recurrent or metastatic disease and were non-refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first. | Participants with R/M disease and were refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first. | Participants with R/M disease and were treated with 1 or more lines of platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first. | Total of all reporting groups |
| Overall Participants | 15 | 9 | 11 | 35 |
| Age (Years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [Years] |
63.6
(8.60)
|
57.3
(7.98)
|
60.4
(5.28)
|
61.0
(7.77)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
0
0%
|
1
11.1%
|
0
0%
|
1
2.9%
|
| Male |
15
100%
|
8
88.9%
|
11
100%
|
34
97.1%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Not Hispanic or Latino |
15
100%
|
9
100%
|
11
100%
|
35
100%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | ||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
1
11.1%
|
0
0%
|
1
2.9%
|
| Black or African American |
0
0%
|
1
11.1%
|
0
0%
|
1
2.9%
|
| White |
15
100%
|
7
77.8%
|
11
100%
|
33
94.3%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) |
|---|---|
| Description | An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. There will be no updated results for this outcome measures at the time of end of study. |
| Time Frame | Day 1 through 90 days after the last dose of study drug (approximately 45 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| As-treated population included all participants who received at least one dose of any study drug. |
| Arm/Group Title | 1L R/M Platinum Non-refractory | 1L R/M Platinum Refractory | 2L+R/M |
|---|---|---|---|
| Arm/Group Description | Participants with recurrent or metastatic disease and were non-refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first. | Participants with R/M disease and were refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first. | Participants with R/M disease and were treated with 1 or more lines of platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first. |
| Measure Participants | 15 | 9 | 11 |
| Any TEAE |
15
100%
|
9
100%
|
11
100%
|
| Any TESAE |
4
26.7%
|
4
44.4%
|
6
54.5%
|
| Title | Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs |
|---|---|
| Description | Any laboratory abnormality during analysis of hematology, clinical chemistry, thyroid function tests, and urinalysis that was new in onset or worsened in severity or frequency from the baseline condition and required therapeutic intervention or diagnostic tests, led to discontinuation of study treatment, had accompanying or inducing symptoms or signs, or judged by the Investigator as clinically significant was recorded as AE. Participants with abnormal laboratory parameters reported as TEAEs are reported. |
| Time Frame | Day 1 through 90 days after the last dose of study drug (approximately 45 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| As-treated population included all participants who received at least one dose of any study drug. |
| Arm/Group Title | 1L R/M Platinum Non-refractory | 1L R/M Platinum Refractory | 2L+R/M |
|---|---|---|---|
| Arm/Group Description | Participants with recurrent or metastatic disease and were non-refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first. | Participants with R/M disease and were refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first. | Participants with R/M disease and were treated with 1 or more lines of platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first. |
| Measure Participants | 15 | 9 | 11 |
| Lymphocyte count decreased |
2
13.3%
|
1
11.1%
|
3
27.3%
|
| Aspartate aminotransferase increased |
1
6.7%
|
1
11.1%
|
3
27.3%
|
| Alanine aminotransferase increased |
2
13.3%
|
1
11.1%
|
1
9.1%
|
| Lipase increased |
2
13.3%
|
1
11.1%
|
1
9.1%
|
| Neutrophil count decreased |
1
6.7%
|
1
11.1%
|
1
9.1%
|
| Platelet count decreased |
2
13.3%
|
1
11.1%
|
0
0%
|
| White blood cell count decreased |
1
6.7%
|
1
11.1%
|
1
9.1%
|
| Blood creatinine increased |
1
6.7%
|
1
11.1%
|
0
0%
|
| Blood thyroid stimulating hormone increased |
0
0%
|
1
11.1%
|
1
9.1%
|
| Blood urea increased |
2
13.3%
|
0
0%
|
0
0%
|
| Amylase increased |
0
0%
|
0
0%
|
1
9.1%
|
| Blood alkaline phosphatase increased |
0
0%
|
0
0%
|
1
9.1%
|
| Blood bilirubin increased |
0
0%
|
1
11.1%
|
0
0%
|
| Blood creatine phosphokinase increased |
0
0%
|
0
0%
|
1
9.1%
|
| Red blood cell count decreased |
1
6.7%
|
0
0%
|
0
0%
|
| Tri-iodothyronine decreased |
0
0%
|
1
11.1%
|
0
0%
|
| Troponin T increased |
1
6.7%
|
0
0%
|
0
0%
|
| White blood cell count increased |
0
0%
|
1
11.1%
|
0
0%
|
| Hyponatraemia |
1
6.7%
|
3
33.3%
|
2
18.2%
|
| Hyperglycaemia |
3
20%
|
1
11.1%
|
1
9.1%
|
| Hypokalaemia |
0
0%
|
3
33.3%
|
1
9.1%
|
| Hypoalbuminaemia |
0
0%
|
0
0%
|
2
18.2%
|
| Hypomagnesaemia |
0
0%
|
1
11.1%
|
1
9.1%
|
| Hypocalcaemia |
0
0%
|
0
0%
|
1
9.1%
|
| Hypoglycaemia |
0
0%
|
1
11.1%
|
0
0%
|
| Hypophosphataemia |
0
0%
|
1
11.1%
|
0
0%
|
| Hypothyroidism |
3
20%
|
2
22.2%
|
2
18.2%
|
| Hyperthyroidism |
0
0%
|
1
11.1%
|
2
18.2%
|
| Anaemia |
3
20%
|
5
55.6%
|
4
36.4%
|
| Neutropenia |
0
0%
|
1
11.1%
|
0
0%
|
| Lymphopenia |
0
0%
|
0
0%
|
1
9.1%
|
| Title | Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs |
|---|---|
| Description | Participants with ECG abnormalities reported as TEAEs are reported. |
| Time Frame | Day 1 through 90 days after the last dose of study drug (approximately 45 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| As-treated population included all participants who received at least one dose of any study drug. |
| Arm/Group Title | 1L R/M Platinum Non-refractory | 1L R/M Platinum Refractory | 2L+R/M |
|---|---|---|---|
| Arm/Group Description | Participants with recurrent or metastatic disease and were non-refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first. | Participants with R/M disease and were refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first. | Participants with R/M disease and were treated with 1 or more lines of platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first. |
| Measure Participants | 15 | 9 | 11 |
| Atrial fibrillation |
1
6.7%
|
2
22.2%
|
1
9.1%
|
| Bradycardia |
0
0%
|
0
0%
|
3
27.3%
|
| Sinus tachycardia |
1
6.7%
|
1
11.1%
|
1
9.1%
|
| Sinus bradycardia |
1
6.7%
|
1
11.1%
|
0
0%
|
| Cardiac failure |
1
6.7%
|
0
0%
|
0
0%
|
| Left ventricular hypertrophy |
0
0%
|
1
11.1%
|
0
0%
|
| Myocarditis |
1
6.7%
|
0
0%
|
0
0%
|
| Pericardial effusion |
0
0%
|
1
11.1%
|
0
0%
|
| Supraventricular tachycardia |
0
0%
|
1
11.1%
|
0
0%
|
| Title | Number of Participants With Abnormal Vital Signs and/or Physical Examination Reported as TEAEs |
|---|---|
| Description | Vital sign assessment included body temperature, respiration rate, pulse oximetry, blood pressure, heart rate, and weight. Participants with abnormal vital sign and/or abnormal physical examination reported as TEAEs are reported. |
| Time Frame | Day 1 through 90 days after the last dose of study drug (approximately 45 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| As-treated population included all participants who received at least one dose of any study drug. |
| Arm/Group Title | 1L R/M Platinum Non-refractory | 1L R/M Platinum Refractory | 2L+R/M |
|---|---|---|---|
| Arm/Group Description | Participants with recurrent or metastatic disease and were non-refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first. | Participants with R/M disease and were refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first. | Participants with R/M disease and were treated with 1 or more lines of platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first. |
| Measure Participants | 15 | 9 | 11 |
| Pyrexia |
1
6.7%
|
4
44.4%
|
2
18.2%
|
| Weight decreased |
4
26.7%
|
2
22.2%
|
2
18.2%
|
| Weight increased |
2
13.3%
|
0
0%
|
0
0%
|
| Breath sounds abnormal |
0
0%
|
0
0%
|
1
9.1%
|
| Dyspnoea |
4
26.7%
|
4
44.4%
|
3
27.3%
|
| Hypertension |
5
33.3%
|
1
11.1%
|
4
36.4%
|
| Hypotension |
1
6.7%
|
0
0%
|
2
18.2%
|
| Blood pressure increased |
1
6.7%
|
0
0%
|
0
0%
|
| Title | Number of Participants Who Received Any Concomitant Medications During the Study |
|---|---|
| Description | Participants who received concomitant medications which were ongoing at the start of treatment or started after the study treatment are included. |
| Time Frame | Day 1 through 90 days after the last dose of study drug (approximately 45 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| As-treated population included all participants who received at least one dose of any study drug. |
| Arm/Group Title | 1L R/M Platinum Non-refractory | 1L R/M Platinum Refractory | 2L+R/M |
|---|---|---|---|
| Arm/Group Description | Participants with recurrent or metastatic disease and were non-refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first. | Participants with R/M disease and were refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first. | Participants with R/M disease and were treated with 1 or more lines of platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first. |
| Measure Participants | 15 | 9 | 11 |
| Count of Participants [Participants] |
15
100%
|
9
100%
|
11
100%
|
| Title | Number of Participants With Shift >=3 Changed From Baseline in Eastern Cooperative Oncology Group Performance (ECOG) Status |
|---|---|
| Description | Participants with shift >=3 changed from baseline in ECOG status are reported. ECOG performance status is used by doctors and researchers to assess how a participant's disease is progressing, assess how the disease affects the daily living activities of the participant and determine appropriate treatment and prognosis. The scores are: 0 = Fully Active, able to carry out all pre-disease performance without restrictions; 1 = Restricted activity but ambulatory and able to carry out light work or work of a sedentary nature; 2 = Ambulatory and capable of self-care but unable to carry out work activities; 3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4 = Completely Disabled, unable to carry out any self-care and totally confined to bed or chair; 5 = Dead. |
| Time Frame | Day 1 through 90 days after the last dose of study drug (approximately 45 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| As-treated population included all participants who received at least one dose of any study drug. |
| Arm/Group Title | 1L R/M Platinum Non-refractory | 1L R/M Platinum Refractory | 2L+R/M |
|---|---|---|---|
| Arm/Group Description | Participants with recurrent or metastatic disease and were non-refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first. | Participants with R/M disease and were refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first. | Participants with R/M disease and were treated with 1 or more lines of platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first. |
| Measure Participants | 15 | 9 | 11 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
1
9.1%
|
| Title | Percentage of Participants With Objective Response by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 in Response-evaluable Population |
|---|---|
| Description | The objective response is defined as confirmed complete response (CR) or confirmed partial response (PR) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) guidelines. The CR is defined as disappearance of all target and non-target lesions, no new lesions, and normalization of tumor marker level. The PR is defined as >= 30% decrease in the sum of the diameters of target lesions compared to baseline and no new non-target lesion. A confirmed CR or PR is defined as 2 CRs or 2 PRs that were separated by at least 4 weeks with no evidence of progression or not evaluable response in-between. Percentage of participants with objective response is reported. |
| Time Frame | Day 1 through end of study (approximately 45 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Response-evaluable population included all participants with confirmed human papilloma virus Type 16 (HPV-16) or HPV-18 associated disease, who received one dose of both study drugs, had a baseline scan (Days -28 to -1) with measurable disease at baseline, and at least one follow-up scan with the opportunity to be followed for >= 16 weeks. |
| Arm/Group Title | 1L R/M Platinum Non-refractory | 1L R/M Platinum Refractory | 2L+R/M |
|---|---|---|---|
| Arm/Group Description | Participants with recurrent or metastatic disease and were non-refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first. | Participants with R/M disease and were refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first. | Participants with R/M disease and were treated with 1 or more lines of platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first. |
| Measure Participants | 12 | 7 | 10 |
| Number (95% Confidence Interval) [Percentage of participants] |
33.3
222%
|
28.6
317.8%
|
20.0
181.8%
|
| Title | Percentage of Participants With Objective Response by RECIST Version 1.1 in As-treated Population |
|---|---|
| Description | The objective response is defined as confirmed CR or confirmed PR based on RECIST v1.1 guidelines. The CR is defined as disappearance of all target and non-target lesions, no new lesions, and normalization of tumor marker level. The PR is defined as >= 30% decrease in the sum of the diameters of target lesions compared to baseline and no new non-target lesion. A confirmed CR or PR is defined as 2 CRs or 2 PRs that were separated by at least 4 weeks with no evidence of progression or not evaluable response in-between. Percentage of participants with objective response is reported. |
| Time Frame | Day 1 through end of study (approximately 45 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| As-treated population included all participants who received at least one dose of any study drug. |
| Arm/Group Title | 1L R/M Platinum Non-refractory | 1L R/M Platinum Refractory | 2L+R/M |
|---|---|---|---|
| Arm/Group Description | Participants with recurrent or metastatic disease and were non-refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first. | Participants with R/M disease and were refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first. | Participants with R/M disease and were treated with 1 or more lines of platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first. |
| Measure Participants | 15 | 9 | 11 |
| Number (95% Confidence Interval) [Percentage of participants] |
33.3
222%
|
22.2
246.7%
|
18.2
165.5%
|
| Title | Percentage of Participants With Objective Response by Immune-related RECIST (irRECIST) in Response-evaluable Population |
|---|---|
| Description | The objective response is defined as confirmed CR or confirmed PR based on irRECIST v1.1 guidelines. The irCR is defined as disappearance of all target and non-target lesions, no new lesions, and normalization of tumor marker level. The irPR is defined as >= 50% decrease in the sum of the diameters of target lesions compared to baseline and no new non-target lesion. A confirmed irCR or irPR is defined as 2 irCRs or 2 irPRs that were separated by at least 4 weeks with no evidence of progression or not evaluable response in-between. Percentage of participants with objective response is reported. |
| Time Frame | Day 1 through end of study (approximately 45 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Response-evaluable population included all participants with confirmed HPV-16 or HPV-18 associated disease, who received one dose of both study drugs, had a baseline scan (Days -28 to -1) with measurable disease at baseline, and at least one follow-up scan with the opportunity to be followed for >= 16 weeks. |
| Arm/Group Title | 1L R/M Platinum Non-refractory | 1L R/M Platinum Refractory | 2L+R/M |
|---|---|---|---|
| Arm/Group Description | Participants with recurrent or metastatic disease and were non-refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first. | Participants with R/M disease and were refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first. | Participants with R/M disease and were treated with 1 or more lines of platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first. |
| Measure Participants | 12 | 7 | 10 |
| Number (95% Confidence Interval) [Percentage of participants] |
41.7
278%
|
28.6
317.8%
|
20.0
181.8%
|
| Title | Percentage of Participants With Objective Response by irRECIST in As-treated Population |
|---|---|
| Description | The objective response is defined as confirmed CR or confirmed PR based on irRECIST v1.1 guidelines. The irCR is defined as disappearance of all target and non-target lesions, no new lesions, and normalization of tumor marker level. The irPR is defined as >= 50% decrease in the sum of the diameters of target lesions compared to baseline and no new non-target lesion. A confirmed irCR or irPR is defined as 2 irCRs or 2 irPRs that were separated by at least 4 weeks with no evidence of progression or not evaluable response in-between. Percentage of participants with objective response is reported. |
| Time Frame | Day 1 through end of study (approximately 45 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| As-treated population included all participants who received at least one dose of any study drug. |
| Arm/Group Title | 1L R/M Platinum Non-refractory | 1L R/M Platinum Refractory | 2L+R/M |
|---|---|---|---|
| Arm/Group Description | Participants with recurrent or metastatic disease and were non-refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first. | Participants with R/M disease and were refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first. | Participants with R/M disease and were treated with 1 or more lines of platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first. |
| Measure Participants | 15 | 9 | 11 |
| Number (95% Confidence Interval) [Percentage of participants] |
40.0
266.7%
|
22.2
246.7%
|
18.2
165.5%
|
| Title | Disease Control Rate (DCR) at Week 16 by RECIST Version 1.1 in Response-evaluable Population |
|---|---|
| Description | The DCR is defined percentage of participants with CR, PR, or stable disease (SD) at 16 weeks based on RECIST v1.1 guidelines. A CR is defined as disappearance of all target and non-target lesions, no new lesions, and normalization of tumor marker level. A PR is defined as >= 30% decrease in the sum of longest diameters of target lesions compared to baseline and no new non-target lesion. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression, taking as reference the smallest sum longest diameter since the study treatment started, and persistence of one or more non-target lesion(s) or / and maintenance of tumor marker level above the normal limits. |
| Time Frame | Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Response-evaluable population included all participants with confirmed HPV-16 or HPV-18 associated disease, who received one dose of both study drugs, had a baseline scan (Days -28 to -1) with measurable disease at baseline, and at least one follow-up scan with the opportunity to be followed for >= 16 weeks. |
| Arm/Group Title | 1L R/M Platinum Non-refractory | 1L R/M Platinum Refractory | 2L+R/M |
|---|---|---|---|
| Arm/Group Description | Participants with recurrent or metastatic disease and were non-refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first. | Participants with R/M disease and were refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first. | Participants with R/M disease and were treated with 1 or more lines of platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first. |
| Measure Participants | 12 | 7 | 10 |
| Number (95% Confidence Interval) [Percentage of participants] |
50.0
333.3%
|
28.6
317.8%
|
50.0
454.5%
|
| Title | DCR at Week 16 by RECIST Version 1.1 in As-treated Population |
|---|---|
| Description | The DCR is defined percentage of participants with CR, PR, or SD at 16 weeks based on RECIST v1.1 guidelines. A CR is defined as disappearance of all target and non-target lesions, no new lesions, and normalization of tumor marker level. A PR is defined as >= 30% decrease in the sum of longest diameters of target lesions compared to baseline and no new non-target lesion. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression, taking as reference the smallest sum longest diameter since the study treatment started, and persistence of one or more non-target lesion(s) or / and maintenance of tumor marker level above the normal limits. |
| Time Frame | Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| As-treated population included all participants who received at least one dose of any study drug. |
| Arm/Group Title | 1L R/M Platinum Non-refractory | 1L R/M Platinum Refractory | 2L+R/M |
|---|---|---|---|
| Arm/Group Description | Participants with recurrent or metastatic disease and were non-refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first. | Participants with R/M disease and were refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first. | Participants with R/M disease and were treated with 1 or more lines of platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first. |
| Measure Participants | 15 | 9 | 11 |
| Number (95% Confidence Interval) [Percentage of participants] |
53.3
355.3%
|
33.3
370%
|
45.5
413.6%
|
| Title | Progression Free Survival (PFS) |
|---|---|
| Description | The PFS is defined as the time from the date of start of study treatment until the documentation of disease progression based on RECIST version 1.1 or death due to any cause, whichever occurs first. The progressive disease is defined at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started, the appearance of one or more new lesions, or unequivocal progression of existing non-target lesions. Participants who were not progressed or died at the time of the analysis were censored at the time of the latest date of assessment from their last evaluable RECIST version 1.1 assessment. The PFS was estimated using Kaplan-Meier method. |
| Time Frame | Day 1 through end of study (approximately 45 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| As-treated population included all participants who received at least one dose of any study drug. |
| Arm/Group Title | 1L R/M Platinum Non-refractory | 1L R/M Platinum Refractory | 2L+R/M |
|---|---|---|---|
| Arm/Group Description | Participants with recurrent or metastatic disease and were non-refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first. | Participants with R/M disease and were refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first. | Participants with R/M disease and were treated with 1 or more lines of platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first. |
| Measure Participants | 15 | 9 | 11 |
| Median (95% Confidence Interval) [Months] |
9.5
|
2.3
|
3.8
|
| Title | Overall Survival (OS) |
|---|---|
| Description | Overall survival is defined as the time from the date of start of study treatment until death due to any cause. Any participant not died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. The OS was estimated using Kaplan-Meier method. |
| Time Frame | Day 1 through end of study (approximately 45 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| As-treated population included all participants who received at least one dose of any study drug. |
| Arm/Group Title | 1L R/M Platinum Non-refractory | 1L R/M Platinum Refractory | 2L+R/M |
|---|---|---|---|
| Arm/Group Description | Participants with recurrent or metastatic disease and were non-refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first. | Participants with R/M disease and were refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first. | Participants with R/M disease and were treated with 1 or more lines of platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first. |
| Measure Participants | 15 | 9 | 11 |
| Median (95% Confidence Interval) [Months] |
NA
|
29.2
|
19.2
|
| Title | Number of Participants With Positive Anti-Drug Antibodies (ADA) to Durvalumab |
|---|---|
| Description | Number of participants with positive ADA titer to durvalumab are reported. ADA prevalence is defined as ADA positive at any point (baseline and post-baseline); persistent positive is defined as ADA positive at Week 16, and transient positive is defined as positive at Week 8 but not at Week 16, regardless of baseline positivity. |
| Time Frame | Pre-dose (up to 60 minutes prior to durvalumab administration) on Week 4, Week 8, and Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The ADA evaluable population included all participants who had non-missing baseline ADAs (on Day 1) and at least one non-missing post-baseline ADA result. |
| Arm/Group Title | 1L R/M Platinum Non-refractory | 1L R/M Platinum Refractory | 2L+R/M |
|---|---|---|---|
| Arm/Group Description | Participants with recurrent or metastatic disease and were non-refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first. | Participants with R/M disease and were refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first. | Participants with R/M disease and were treated with 1 or more lines of platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first. |
| Measure Participants | 15 | 9 | 11 |
| ADA prevalence |
0
0%
|
0
0%
|
1
9.1%
|
| Persistent positive ADA |
0
0%
|
0
0%
|
0
0%
|
| Transient positive ADA |
0
0%
|
0
0%
|
0
0%
|
| Title | Serum Concentrations of Durvalumab |
|---|---|
| Description | Serum concentrations of durvalumab is reported. |
| Time Frame | Pre-dose (up to 60 minutes prior to durvalumab administration) on Week 4, Week 8, and Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacokinetics population included all participants who received at least one dose of durvalumab and had at least one evaluable post-dose serum concentration measurement of durvalumab. 'Number analyzed' denotes the number of participants evaluated for the specified time point. |
| Arm/Group Title | 1L R/M Platinum Non-refractory | 1L R/M Platinum Refractory | 2L+R/M |
|---|---|---|---|
| Arm/Group Description | Participants with recurrent or metastatic disease and were non-refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first. | Participants with R/M disease and were refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first. | Participants with R/M disease and were treated with 1 or more lines of platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first. |
| Measure Participants | 12 | 7 | 10 |
| Week 4 pre-dose |
0.767
(NA)
|
1.505
(NA)
|
|
| Week 8 pre-dose |
92.163
(37.823)
|
89.094
(69.586)
|
94.665
(50.546)
|
| Week 16 pre-dose |
190.061
(94.466)
|
127.269
(56.927)
|
121.728
(79.189)
|
Adverse Events
| Time Frame | Day 1 through 90 days after the last dose of study drug (approximately 45 months) | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | 1L R/M Platinum Non-refractory | 1L R/M Platinum Refractory | 2L+ R/M | |||
| Arm/Group Description | Description (Arm-group) | Description (Arm-group) | Description (Arm-group) | |||
All Cause Mortality |
||||||
| 1L R/M Platinum Non-refractory | 1L R/M Platinum Refractory | 2L+ R/M | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/15 (26.7%) | 5/9 (55.6%) | 8/11 (72.7%) | |||
Serious Adverse Events |
||||||
| 1L R/M Platinum Non-refractory | 1L R/M Platinum Refractory | 2L+ R/M | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/15 (26.7%) | 4/9 (44.4%) | 6/11 (54.5%) | |||
| Blood and lymphatic system disorders | ||||||
| Anaemia | 0/15 (0%) | 0 | 0/9 (0%) | 0 | 1/11 (9.1%) | 1 |
| Cardiac disorders | ||||||
| Myocarditis | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Atrial fibrillation | 0/15 (0%) | 0 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Cardiac failure | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Gastrointestinal disorders | ||||||
| Dysphagia | 0/15 (0%) | 0 | 0/9 (0%) | 0 | 1/11 (9.1%) | 1 |
| Oesophageal stenosis | 0/15 (0%) | 0 | 0/9 (0%) | 0 | 1/11 (9.1%) | 1 |
| Oesophagitis | 0/15 (0%) | 0 | 0/9 (0%) | 0 | 1/11 (9.1%) | 1 |
| Vomiting | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Immune system disorders | ||||||
| Anaphylactic reaction | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Infections and infestations | ||||||
| Muscle abscess | 0/15 (0%) | 0 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Pneumonia | 0/15 (0%) | 0 | 1/9 (11.1%) | 1 | 2/11 (18.2%) | 2 |
| Injury, poisoning and procedural complications | ||||||
| Fall | 0/15 (0%) | 0 | 0/9 (0%) | 0 | 1/11 (9.1%) | 1 |
| Pelvic fracture | 0/15 (0%) | 0 | 0/9 (0%) | 0 | 1/11 (9.1%) | 1 |
| Tracheal obstruction | 0/15 (0%) | 0 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Investigations | ||||||
| Alanine aminotransferase increased | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Aspartate aminotransferase increased | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Nervous system disorders | ||||||
| Seizure | 0/15 (0%) | 0 | 0/9 (0%) | 0 | 1/11 (9.1%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Bronchial haemorrhage | 0/15 (0%) | 0 | 0/9 (0%) | 0 | 1/11 (9.1%) | 1 |
| Haemoptysis | 0/15 (0%) | 0 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Laryngeal oedema | 0/15 (0%) | 0 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Respiratory failure | 0/15 (0%) | 0 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Stridor | 0/15 (0%) | 0 | 0/9 (0%) | 0 | 1/11 (9.1%) | 1 |
Other (Not Including Serious) Adverse Events |
||||||
| 1L R/M Platinum Non-refractory | 1L R/M Platinum Refractory | 2L+ R/M | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 15/15 (100%) | 9/9 (100%) | 11/11 (100%) | |||
| Blood and lymphatic system disorders | ||||||
| Anaemia | 3/15 (20%) | 3 | 5/9 (55.6%) | 7 | 4/11 (36.4%) | 8 |
| Lymph node pain | 0/15 (0%) | 0 | 0/9 (0%) | 0 | 1/11 (9.1%) | 1 |
| Lymphadenopathy | 0/15 (0%) | 0 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Lymphopenia | 0/15 (0%) | 0 | 0/9 (0%) | 0 | 1/11 (9.1%) | 1 |
| Neutropenia | 0/15 (0%) | 0 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Cardiac disorders | ||||||
| Left ventricular hypertrophy | 0/15 (0%) | 0 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Myocarditis | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Pericardial effusion | 0/15 (0%) | 0 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Sinus bradycardia | 1/15 (6.7%) | 1 | 1/9 (11.1%) | 2 | 0/11 (0%) | 0 |
| Sinus tachycardia | 1/15 (6.7%) | 1 | 1/9 (11.1%) | 3 | 1/11 (9.1%) | 1 |
| Supraventricular tachycardia | 0/15 (0%) | 0 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Atrial fibrillation | 1/15 (6.7%) | 3 | 1/9 (11.1%) | 1 | 1/11 (9.1%) | 2 |
| Bradycardia | 0/15 (0%) | 0 | 0/9 (0%) | 0 | 3/11 (27.3%) | 3 |
| Ear and labyrinth disorders | ||||||
| Deafness bilateral | 0/15 (0%) | 0 | 0/9 (0%) | 0 | 1/11 (9.1%) | 1 |
| Ear pain | 0/15 (0%) | 0 | 1/9 (11.1%) | 1 | 1/11 (9.1%) | 1 |
| Tinnitus | 0/15 (0%) | 0 | 2/9 (22.2%) | 2 | 1/11 (9.1%) | 1 |
| Endocrine disorders | ||||||
| Hyperthyroidism | 0/15 (0%) | 0 | 1/9 (11.1%) | 1 | 2/11 (18.2%) | 2 |
| Hypothyroidism | 3/15 (20%) | 3 | 2/9 (22.2%) | 2 | 2/11 (18.2%) | 2 |
| Eye disorders | ||||||
| Cataract | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Corneal thinning | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Ocular hyperaemia | 1/15 (6.7%) | 2 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Retinal detachment | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 1/11 (9.1%) | 2 |
| Retinal tear | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Vision blurred | 2/15 (13.3%) | 2 | 0/9 (0%) | 0 | 1/11 (9.1%) | 1 |
| Visual impairment | 0/15 (0%) | 0 | 0/9 (0%) | 0 | 1/11 (9.1%) | 2 |
| Eye irritation | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Eye swelling | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Gastrointestinal disorders | ||||||
| Abdominal distension | 0/15 (0%) | 0 | 0/9 (0%) | 0 | 1/11 (9.1%) | 1 |
| Abdominal pain | 0/15 (0%) | 0 | 0/9 (0%) | 0 | 1/11 (9.1%) | 3 |
| Abdominal pain lower | 0/15 (0%) | 0 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Anal incontinence | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Constipation | 2/15 (13.3%) | 2 | 3/9 (33.3%) | 3 | 3/11 (27.3%) | 3 |
| Diarrhoea | 2/15 (13.3%) | 5 | 2/9 (22.2%) | 6 | 2/11 (18.2%) | 9 |
| Dry mouth | 2/15 (13.3%) | 2 | 0/9 (0%) | 0 | 2/11 (18.2%) | 2 |
| Dyspepsia | 1/15 (6.7%) | 1 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Glossodynia | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 1/11 (9.1%) | 1 |
| Large intestine polyp | 0/15 (0%) | 0 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Lip dry | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Mouth haemorrhage | 0/15 (0%) | 0 | 0/9 (0%) | 0 | 1/11 (9.1%) | 1 |
| Nausea | 5/15 (33.3%) | 5 | 2/9 (22.2%) | 4 | 3/11 (27.3%) | 3 |
| Salivary hypersecretion | 2/15 (13.3%) | 2 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Vomiting | 2/15 (13.3%) | 2 | 3/9 (33.3%) | 4 | 1/11 (9.1%) | 1 |
| Dysphagia | 2/15 (13.3%) | 2 | 2/9 (22.2%) | 3 | 2/11 (18.2%) | 2 |
| Eructation | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Flatulence | 0/15 (0%) | 0 | 0/9 (0%) | 0 | 1/11 (9.1%) | 1 |
| Mouth swelling | 0/15 (0%) | 0 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Odynophagia | 2/15 (13.3%) | 2 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| General disorders | ||||||
| Administration site bruise | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Administration site induration | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Administration site pain | 2/15 (13.3%) | 7 | 1/9 (11.1%) | 2 | 1/11 (9.1%) | 8 |
| Administration site reaction | 1/15 (6.7%) | 1 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Administration site swelling | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Catheter site pruritus | 0/15 (0%) | 0 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Chest pain | 0/15 (0%) | 0 | 0/9 (0%) | 0 | 1/11 (9.1%) | 3 |
| Chills | 2/15 (13.3%) | 2 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Face oedema | 0/15 (0%) | 0 | 1/9 (11.1%) | 2 | 1/11 (9.1%) | 1 |
| Facial pain | 0/15 (0%) | 0 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Fatigue | 9/15 (60%) | 16 | 6/9 (66.7%) | 6 | 4/11 (36.4%) | 4 |
| Fibrosis | 0/15 (0%) | 0 | 0/9 (0%) | 0 | 1/11 (9.1%) | 1 |
| Gait disturbance | 0/15 (0%) | 0 | 0/9 (0%) | 0 | 1/11 (9.1%) | 1 |
| Influenza like illness | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Injection site discomfort | 1/15 (6.7%) | 2 | 0/9 (0%) | 0 | 1/11 (9.1%) | 1 |
| Injection site pain | 4/15 (26.7%) | 12 | 4/9 (44.4%) | 13 | 1/11 (9.1%) | 1 |
| Injection site swelling | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Localised oedema | 0/15 (0%) | 0 | 0/9 (0%) | 0 | 1/11 (9.1%) | 1 |
| Non-cardiac chest pain | 3/15 (20%) | 4 | 0/9 (0%) | 0 | 2/11 (18.2%) | 3 |
| Oedema peripheral | 2/15 (13.3%) | 2 | 0/9 (0%) | 0 | 1/11 (9.1%) | 1 |
| Pain | 0/15 (0%) | 0 | 2/9 (22.2%) | 2 | 0/11 (0%) | 0 |
| Pyrexia | 1/15 (6.7%) | 1 | 4/9 (44.4%) | 4 | 2/11 (18.2%) | 2 |
| Swelling face | 0/15 (0%) | 0 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Vaccination site pain | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Infections and infestations | ||||||
| Bronchitis | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Conjunctivitis | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Diverticulitis | 0/15 (0%) | 0 | 0/9 (0%) | 0 | 1/11 (9.1%) | 1 |
| Epididymitis | 0/15 (0%) | 0 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Herpes zoster | 0/15 (0%) | 0 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Hordeolum | 0/15 (0%) | 0 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Kidney infection | 0/15 (0%) | 0 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Laryngitis | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Nasopharyngitis | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Ophthalmic herpes zoster | 1/15 (6.7%) | 3 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Oral herpes | 0/15 (0%) | 0 | 1/9 (11.1%) | 2 | 0/11 (0%) | 0 |
| Oral infection | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Pilonidal cyst | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Pneumonia | 1/15 (6.7%) | 2 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Upper respiratory tract infection | 1/15 (6.7%) | 1 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Wound infection | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Candida infection | 0/15 (0%) | 0 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Influenza | 0/15 (0%) | 0 | 0/9 (0%) | 0 | 1/11 (9.1%) | 1 |
| Oral candidiasis | 1/15 (6.7%) | 2 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Sinusitis | 1/15 (6.7%) | 1 | 1/9 (11.1%) | 1 | 2/11 (18.2%) | 2 |
| Injury, poisoning and procedural complications | ||||||
| Fall | 1/15 (6.7%) | 1 | 2/9 (22.2%) | 2 | 0/11 (0%) | 0 |
| Incision site erythema | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Infusion related reaction | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Joint injury | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Nasal injury | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Osteoradionecrosis | 0/15 (0%) | 0 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Pelvic fracture | 0/15 (0%) | 0 | 0/9 (0%) | 0 | 1/11 (9.1%) | 1 |
| Rib fracture | 0/15 (0%) | 0 | 1/9 (11.1%) | 1 | 1/11 (9.1%) | 1 |
| Skin abrasion | 1/15 (6.7%) | 2 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Contusion | 1/15 (6.7%) | 1 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Arthropod bite | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Investigations | ||||||
| Alanine aminotransferase increased | 2/15 (13.3%) | 2 | 1/9 (11.1%) | 2 | 1/11 (9.1%) | 1 |
| Amylase increased | 0/15 (0%) | 0 | 0/9 (0%) | 0 | 1/11 (9.1%) | 1 |
| Aspartate aminotransferase increased | 1/15 (6.7%) | 1 | 1/9 (11.1%) | 5 | 3/11 (27.3%) | 3 |
| Blood alkaline phosphatase increased | 0/15 (0%) | 0 | 0/9 (0%) | 0 | 1/11 (9.1%) | 2 |
| Blood bilirubin increased | 0/15 (0%) | 0 | 1/9 (11.1%) | 3 | 0/11 (0%) | 0 |
| Blood creatine phosphokinase increased | 0/15 (0%) | 0 | 0/9 (0%) | 0 | 1/11 (9.1%) | 3 |
| Blood creatinine increased | 1/15 (6.7%) | 1 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Blood pressure increased | 1/15 (6.7%) | 2 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Blood thyroid stimulating hormone increased | 0/15 (0%) | 0 | 1/9 (11.1%) | 1 | 1/11 (9.1%) | 2 |
| Blood urea increased | 2/15 (13.3%) | 3 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Breath sounds abnormal | 0/15 (0%) | 0 | 0/9 (0%) | 0 | 1/11 (9.1%) | 1 |
| Lipase increased | 2/15 (13.3%) | 2 | 1/9 (11.1%) | 1 | 1/11 (9.1%) | 1 |
| Lymphocyte count decreased | 2/15 (13.3%) | 7 | 1/9 (11.1%) | 3 | 3/11 (27.3%) | 7 |
| Neutrophil count decreased | 1/15 (6.7%) | 1 | 1/9 (11.1%) | 1 | 1/11 (9.1%) | 1 |
| Platelet count decreased | 2/15 (13.3%) | 3 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Red blood cell count decreased | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Tri-iodothyronine decreased | 0/15 (0%) | 0 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Troponin t increased | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Weight decreased | 4/15 (26.7%) | 4 | 2/9 (22.2%) | 3 | 2/11 (18.2%) | 6 |
| Weight increased | 2/15 (13.3%) | 3 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| White blood cell count decreased | 1/15 (6.7%) | 1 | 1/9 (11.1%) | 1 | 1/11 (9.1%) | 2 |
| White blood cell count increased | 0/15 (0%) | 0 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||
| Decreased appetite | 3/15 (20%) | 3 | 1/9 (11.1%) | 1 | 2/11 (18.2%) | 3 |
| Dehydration | 2/15 (13.3%) | 2 | 2/9 (22.2%) | 2 | 0/11 (0%) | 0 |
| Diabetes mellitus | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Hyperglycaemia | 3/15 (20%) | 3 | 1/9 (11.1%) | 1 | 1/11 (9.1%) | 6 |
| Hypoalbuminaemia | 0/15 (0%) | 0 | 0/9 (0%) | 0 | 2/11 (18.2%) | 4 |
| Hypocalcaemia | 0/15 (0%) | 0 | 0/9 (0%) | 0 | 1/11 (9.1%) | 1 |
| Hypoglycaemia | 0/15 (0%) | 0 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Hypokalaemia | 0/15 (0%) | 0 | 3/9 (33.3%) | 6 | 1/11 (9.1%) | 1 |
| Hypomagnesaemia | 0/15 (0%) | 0 | 1/9 (11.1%) | 1 | 1/11 (9.1%) | 1 |
| Hyponatraemia | 1/15 (6.7%) | 2 | 3/9 (33.3%) | 5 | 2/11 (18.2%) | 2 |
| Hypophosphataemia | 0/15 (0%) | 0 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||
| Arthralgia | 2/15 (13.3%) | 3 | 2/9 (22.2%) | 11 | 2/11 (18.2%) | 3 |
| Back pain | 2/15 (13.3%) | 2 | 2/9 (22.2%) | 4 | 4/11 (36.4%) | 4 |
| Flank pain | 0/15 (0%) | 0 | 0/9 (0%) | 0 | 1/11 (9.1%) | 1 |
| Joint effusion | 0/15 (0%) | 0 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Joint range of motion decreased | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Muscle spasms | 0/15 (0%) | 0 | 1/9 (11.1%) | 1 | 1/11 (9.1%) | 1 |
| Musculoskeletal chest pain | 0/15 (0%) | 0 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Musculoskeletal stiffness | 0/15 (0%) | 0 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Myalgia | 2/15 (13.3%) | 5 | 1/9 (11.1%) | 2 | 1/11 (9.1%) | 1 |
| Myositis | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Neck pain | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 1/11 (9.1%) | 1 |
| Osteopenia | 0/15 (0%) | 0 | 0/9 (0%) | 0 | 1/11 (9.1%) | 1 |
| Pain in extremity | 0/15 (0%) | 0 | 2/9 (22.2%) | 6 | 3/11 (27.3%) | 5 |
| Pain in jaw | 1/15 (6.7%) | 1 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Rotator cuff syndrome | 0/15 (0%) | 0 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Trismus | 0/15 (0%) | 0 | 2/9 (22.2%) | 3 | 1/11 (9.1%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Gastrointestinal tract adenoma | 0/15 (0%) | 0 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Melanocytic naevus | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Nervous system disorders | ||||||
| Accessory nerve disorder | 0/15 (0%) | 0 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Carotid artery stenosis | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Dizziness | 1/15 (6.7%) | 1 | 2/9 (22.2%) | 3 | 2/11 (18.2%) | 2 |
| Dizziness postural | 1/15 (6.7%) | 1 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Headache | 3/15 (20%) | 3 | 3/9 (33.3%) | 4 | 1/11 (9.1%) | 1 |
| Memory impairment | 1/15 (6.7%) | 2 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Migraine | 0/15 (0%) | 0 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Muscle spasticity | 0/15 (0%) | 0 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Peripheral sensory neuropathy | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Post herpetic neuralgia | 0/15 (0%) | 0 | 1/9 (11.1%) | 2 | 0/11 (0%) | 0 |
| Presyncope | 0/15 (0%) | 0 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Syncope | 0/15 (0%) | 0 | 1/9 (11.1%) | 3 | 0/11 (0%) | 0 |
| Taste disorder | 0/15 (0%) | 0 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Tremor | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Vertebral artery stenosis | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Vocal cord paralysis | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Product Issues | ||||||
| Device leakage | 0/15 (0%) | 0 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Psychiatric disorders | ||||||
| Abnormal dreams | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Agitation | 0/15 (0%) | 0 | 0/9 (0%) | 0 | 1/11 (9.1%) | 1 |
| Anxiety | 3/15 (20%) | 4 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Confusional state | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Depression | 2/15 (13.3%) | 2 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Insomnia | 3/15 (20%) | 3 | 0/9 (0%) | 0 | 2/11 (18.2%) | 2 |
| Sleep disorder | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 1/11 (9.1%) | 1 |
| Renal and urinary disorders | ||||||
| Dysuria | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Nocturia | 0/15 (0%) | 0 | 2/9 (22.2%) | 2 | 0/11 (0%) | 0 |
| Reproductive system and breast disorders | ||||||
| Prostatomegaly | 0/15 (0%) | 0 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Scrotal erythema | 0/15 (0%) | 0 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Aspiration | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Atelectasis | 0/15 (0%) | 0 | 0/9 (0%) | 0 | 1/11 (9.1%) | 1 |
| Cough | 5/15 (33.3%) | 7 | 4/9 (44.4%) | 6 | 7/11 (63.6%) | 8 |
| Dysphonia | 2/15 (13.3%) | 2 | 1/9 (11.1%) | 2 | 1/11 (9.1%) | 1 |
| Dyspnoea | 4/15 (26.7%) | 4 | 4/9 (44.4%) | 5 | 3/11 (27.3%) | 4 |
| Dyspnoea exertional | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Epistaxis | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Haemoptysis | 2/15 (13.3%) | 5 | 1/9 (11.1%) | 1 | 2/11 (18.2%) | 2 |
| Hiccups | 2/15 (13.3%) | 2 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Nasal congestion | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 1/11 (9.1%) | 3 |
| Oropharyngeal pain | 2/15 (13.3%) | 2 | 1/9 (11.1%) | 1 | 1/11 (9.1%) | 1 |
| Paranasal sinus hypersecretion | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Pleural effusion | 0/15 (0%) | 0 | 0/9 (0%) | 0 | 1/11 (9.1%) | 1 |
| Pneumothorax | 0/15 (0%) | 0 | 0/9 (0%) | 0 | 1/11 (9.1%) | 1 |
| Productive cough | 1/15 (6.7%) | 1 | 2/9 (22.2%) | 2 | 0/11 (0%) | 0 |
| Pulmonary embolism | 0/15 (0%) | 0 | 0/9 (0%) | 0 | 2/11 (18.2%) | 2 |
| Respiration abnormal | 0/15 (0%) | 0 | 0/9 (0%) | 0 | 1/11 (9.1%) | 1 |
| Respiratory distress | 0/15 (0%) | 0 | 0/9 (0%) | 0 | 1/11 (9.1%) | 1 |
| Rhinitis allergic | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 1/11 (9.1%) | 1 |
| Rhinorrhoea | 2/15 (13.3%) | 2 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Sinus congestion | 0/15 (0%) | 0 | 1/9 (11.1%) | 2 | 0/11 (0%) | 0 |
| Stridor | 0/15 (0%) | 0 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Upper-airway cough syndrome | 1/15 (6.7%) | 1 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Wheezing | 1/15 (6.7%) | 1 | 1/9 (11.1%) | 2 | 1/11 (9.1%) | 1 |
| Skin and subcutaneous tissue disorders | ||||||
| Dermatitis | 0/15 (0%) | 0 | 2/9 (22.2%) | 2 | 0/11 (0%) | 0 |
| Dermatitis acneiform | 2/15 (13.3%) | 2 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Dry skin | 1/15 (6.7%) | 1 | 3/9 (33.3%) | 3 | 0/11 (0%) | 0 |
| Eczema | 0/15 (0%) | 0 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Erythema | 1/15 (6.7%) | 1 | 2/9 (22.2%) | 2 | 0/11 (0%) | 0 |
| Hyperhidrosis | 0/15 (0%) | 0 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Hyperkeratosis | 0/15 (0%) | 0 | 1/9 (11.1%) | 4 | 0/11 (0%) | 0 |
| Night sweats | 0/15 (0%) | 0 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Pemphigoid | 1/15 (6.7%) | 3 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Pruritus | 2/15 (13.3%) | 8 | 2/9 (22.2%) | 4 | 0/11 (0%) | 0 |
| Rash | 3/15 (20%) | 3 | 3/9 (33.3%) | 3 | 1/11 (9.1%) | 1 |
| Rash erythematous | 0/15 (0%) | 0 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Rash papular | 1/15 (6.7%) | 2 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Reactive perforating collagenosis | 0/15 (0%) | 0 | 1/9 (11.1%) | 2 | 0/11 (0%) | 0 |
| Skin mass | 0/15 (0%) | 0 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Skin ulcer | 1/15 (6.7%) | 1 | 0/9 (0%) | 0 | 0/11 (0%) | 0 |
| Telangiectasia | 0/15 (0%) | 0 | 0/9 (0%) | 0 | 1/11 (9.1%) | 1 |
| Vascular disorders | ||||||
| Aortic aneurysm | 0/15 (0%) | 0 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Hot flush | 0/15 (0%) | 0 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
| Hypertension | 5/15 (33.3%) | 8 | 1/9 (11.1%) | 3 | 4/11 (36.4%) | 11 |
| Hypotension | 1/15 (6.7%) | 2 | 0/9 (0%) | 0 | 2/11 (18.2%) | 2 |
| Lymphoedema | 1/15 (6.7%) | 1 | 1/9 (11.1%) | 1 | 1/11 (9.1%) | 1 |
| Thrombosis | 0/15 (0%) | 0 | 1/9 (11.1%) | 1 | 0/11 (0%) | 0 |
Limitations/Caveats
The expected response in terms of efficacy was not achieved at the time of DCO. It was therefore decided to stop further enrollment of participants and the study was terminated. There were no safety concerns were noted with the combination of MEDI0457 and durvalumab.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
Results Point of Contact
| Name/Title | Global Clinical Lead |
|---|---|
| Organization | Global Clinical Lead |
| Phone | 1-877-240-9479 |
| information.center@astrazeneca.com |
Responsible Party:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT03162224
Other Study ID Numbers:
- D8860C00005
First Posted:
May 22, 2017
Last Update Posted:
Aug 25, 2022
Last Verified:
Aug 1, 2022