Ipilimumab vs Ipilimumab Plus Nivolumab in Patients With Stage III-IV Melanoma Who Have Progressed or Relapsed on PD-1 Inhibitor Therapy
Study Details
Study Description
Brief Summary
The purpose of this research study is to learn whether patients whose disease grows after being treated with nivolumab or pembrolizumab respond to ipilimumab (Yervoy®) alone or in combination with nivolumab (Opdivo®).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ipilimumab and nivolumab For patients in the combination arm, nivolumab will first be administered intravenously at a dose of 1 mg/kg of body weight over a period of 60 minutes, once every 3 weeks for four doses. Thirty minutes after the completion of each nivolumab infusion, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes. |
Drug: ipilimumab
Other Names:
Drug: nivolumab
Other Names:
|
| Experimental: ipilimumab In the ipilimumab monotherapy group, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes once every 3 weeks for four doses. |
Drug: ipilimumab
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Overall Response Rate (ORR) as Defined by RECIST v1.1 at Week 18 [Week 18]
Overall Response Rate was defined as any participant who had a Complete Response (CR) or Partial Response (PR) as defined by RECIST v1.1 by week 18 of treatment.
Secondary Outcome Measures
- Disease Control Rate (DCR) Status at Week 18 [Week 18]
Disease Control Rate was defined as any participant who achieved a complete response (CR), partial response (PR), or who remained stable (SD) as defined in Recist v1.1 at week 18.
- Time to Treatment Failure (TTF) [The time from treatment initiation until a subsequent therapy is started or death.]
Time to Treatment Failure is defined as the time from treatment initiation until the participant starts a subsequent therapy or death, whichever comes first.
- Overall Survival (OS) [Death]
Overall Survival is defined as the time of treatment initiation to death by any cause
- Number of Participants With Grade 3 or 4 Adverse Events [AE were monitored during each treatment cycle and could be reported until 30 days after the last dose of study treatment had been administered.]
The occurrence of Grade 3 and Grade 4 adverse events (AE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
- Disease Control Rate (DCR) Status at Week 12 [Week 12]
Disease Control Rate was defined as any participant who achieved a complete response (CR), partial response (PR), or who remained stable (SD) as defined in Recist v1.1 at week 12.
Eligibility Criteria
Criteria
Main Inclusion Criteria:
-
American Joint Committee on Cancer (AJCC) (2009) Stage IV cutaneous melanoma or Stage III cutaneous, acral or mucosal melanoma that is judged inoperable. Patients with a history of uveal melanoma are not eligible.
-
Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with computerized tomography (CT) scan. Patients must have at least one measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) and a separate lesion amenable to biopsy.
-
Histologic proof of melanoma reviewed and confirmed by the enrolling site.
-
Previous treatment with a programmed cell death protein 1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor with documented progression of disease on most recent CT scan. Progression of disease is defined as 1) the appearance of a new measureable lesion (>10 mm) on cross-sectional imaging or physical examination OR 2) enlargement of previously detected lesions on two consecutive imaging studies OR 3) enlargement of a previously detected lesion with correlative symptomatology on one cross-sectional imaging study. Patients remain eligible if they had a previous response to a PD-1 inhibitor, including patients who had a complete response, partial response or stable disease (SD). Primary progressing patients are defined as those who received anti-PD-1 therapy within 2 months of study enrollment. Patients with relapsed disease are defined as those who received their last dose of PD-1 blocking antibody ≥2 months prior to enrollment.
-
Patients who received adjuvant PD-1 therapy who then develop measurable disease are eligible. However, they must have received their last dose of PD-1/PD-L1 blockade within two months of enrollment in this study. They will be stratified with patients who have primary progressive disease.
-
Life expectancy of greater than 3 months.
-
Age ≥ 18 years old.
-
Eastern Cooperative Oncology Group performance status = 0 or 1 or Karnofsky Performance Status equivalent.
-
Patients must have adequate organ and marrow function as defined below:
-
White blood cells >2, 000/microliter (mcL)
-
Absolute neutrophil count >1,500/mcL
-
Platelets >100,000/mcL
-
Hemoglobin > 9.0 g/dL
-
Total bilirubin ≤ 1.5 X institution's upper limit of normal
-
Aspartate aminotransferase (serum glutamic oxaloacetic transaminase)/alanine aminotransferase (serum glutamic pyruvic transaminase) ≤ 2.5 X institution's upper limit of normal for patients with no concurrent liver metastases, OR ≤ 5 X institution's upper limit of normal for patients with concurrent liver metastases
-
Serum creatinine < 1.5x OR creatinine clearance of at least 40
-
Women of childbearing potential must have a negative serum pregnancy test within 24 hours prior to the start of study drug. A woman of childbearing potential is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over age 50 in the absence of other biologic or physiologic causes.
-
Women with child bearing potential and men with reproductive potential must be willing to practice acceptable methods of contraception.
-
Ability to understand and the willingness to sign a written informed consent document.
-
Willingness to undergo biopsy of metastatic site or site of unresectable disease prior to randomization.
Main Exclusion Criteria:
-
History of another malignancy except for those who have been disease-free for 3 years, or patients with a history of completely resected non-melanoma skin cancer and/or patients with indolent secondary malignancies not requiring active therapy, are eligible. Consult the study Medical Monitor if unsure whether second malignancies meet the requirements specified above.
-
Any major surgical procedures or external beam radiotherapy within 14 days prior to study drug administration.
-
Use of other investigational drugs within 28 days prior to study drug administration.
-
Symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression. Treated brain metastases must have been stable for at least 1 month and require treatment with less than 10mg/day prednisone equivalent for at least 2 weeks prior to study drug administration.
-
Prior exposure to either ipilimumab or combined checkpoint blockade.
-
Any diagnosis of autoimmune disease. Patients with Type I diabetes mellitus, hypothyroidism only requiring hormone replacement, adrenal insufficiency on replacement dose steroids, skin disorders (such as vitiligo, psoriasis or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
-
Pregnant women and lactating women.
-
History of uveal melanoma.
-
Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection (with the exception of chronic or cleared HBV or HCV infection, which will be allowed). Once-documented negative result for HIV, HBV, and HCV is sufficient.
-
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection and psychiatric illness/social situations that would limit compliance with study requirements.
-
Patients with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement steroid doses > 10 mg daily prednisone equivalent are permitted.
-
Patients with history of any grade 4 toxicity during previous anti PD-1 treatment or history of Grade 3 or higher pneumonitis.
-
Patients with a history of Grade ≥2 neuropathy.
-
Prisoners or patients who are involuntarily incarcerated.
-
Children under the age of 18.
-
Patients who require hemodialysis.
-
Patients with a history of allergy to study drug components or history of a severe hypersensitivity reaction to any monoclonal antibody.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of California, Los Angeles | Los Angeles | California | United States | 90095 |
| 2 | University of California, San Francisco | San Francisco | California | United States | 94134 |
| 3 | Memorial Sloan Kettering Basking Ridge | Basking Ridge | New Jersey | United States | 07920 |
| 4 | Memorial Sloan Kettering Westchester | Harrison | New York | United States | 10604 |
| 5 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
| 6 | Lehigh Valley Health Network | Allentown | Pennsylvania | United States | 18103 |
| 7 | University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
Sponsors and Collaborators
- Parker Institute for Cancer Immunotherapy
- Bristol-Myers Squibb
Investigators
- Study Director: Ramy Ibrahim, MD, Parker Institute for Cancer Immunotherapy
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- PICI0001
- 16-043
Study Results
Participant Flow
| Recruitment Details | Participants were recruited at four institutions in the United States. Recruitment occurred between June 2016 to May 2018. |
|---|---|
| Pre-assignment Detail | 33 participants were assessed for eligibility. Out of the 33 participants, 20 patients met the inclusion/exclusion criteria and were randomized to the study arms. |
| Arm/Group Title | Ipilimumab and Nivolumab | Ipilimumab |
|---|---|---|
| Arm/Group Description | For patients in the combination arm, nivolumab will first be administered intravenously at a dose of 1 mg/kg of body weight over a period of 60 minutes, once every 3 weeks for four doses. Thirty minutes after the completion of each nivolumab infusion, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes. ipilimumab nivolumab | In the ipilimumab monotherapy group, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes once every 3 weeks for four doses. ipilimumab |
| Period Title: Overall Study | ||
| STARTED | 10 | 10 |
| COMPLETED | 1 | 2 |
| NOT COMPLETED | 9 | 8 |
Baseline Characteristics
| Arm/Group Title | Ipilimumab and Nivolumab | Ipilimumab | Total |
|---|---|---|---|
| Arm/Group Description | For patients in the combination arm, nivolumab will first be administered intravenously at a dose of 1 mg/kg of body weight over a period of 60 minutes, once every 3 weeks for four doses. Thirty minutes after the completion of each nivolumab infusion, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes. ipilimumab nivolumab | In the ipilimumab monotherapy group, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes once every 3 weeks for four doses. ipilimumab | Total of all reporting groups |
| Overall Participants | 10 | 9 | 19 |
| Age (years) [Median (Full Range) ] | |||
| Median (Full Range) [years] |
66
|
56
|
60
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
1
10%
|
3
33.3%
|
4
21.1%
|
| Male |
9
90%
|
6
66.7%
|
15
78.9%
|
| Race/Ethnicity, Customized (Count of Participants) | |||
| Asian |
1
10%
|
0
0%
|
1
5.3%
|
| White |
7
70%
|
9
100%
|
16
84.2%
|
| Other |
2
20%
|
0
0%
|
2
10.5%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
10
100%
|
9
100%
|
19
100%
|
| ECOG Performance Status (Count of Participants) | |||
| ECOG Score = 0 |
7
70%
|
6
66.7%
|
13
68.4%
|
| ECOG Score = 1 |
3
30%
|
3
33.3%
|
6
31.6%
|
| M stage (Count of Participants) | |||
| M0 |
1
10%
|
3
33.3%
|
4
21.1%
|
| M1a |
2
20%
|
1
11.1%
|
3
15.8%
|
| M1b |
3
30%
|
2
22.2%
|
5
26.3%
|
| M1c - without brain metastases |
4
40%
|
3
33.3%
|
7
36.8%
|
| Type of Melanoma (Count of Participants) | |||
| Acral |
1
10%
|
1
11.1%
|
2
10.5%
|
| Cutaneous |
8
80%
|
7
77.8%
|
15
78.9%
|
| Mucosal |
1
10%
|
1
11.1%
|
2
10.5%
|
| Genomic Driver (Count of Participants) | |||
| v-RAF murine sarcoma viral oncogene homolog B1 (BRAF) |
3
30%
|
2
22.2%
|
5
26.3%
|
| Neuroblastoma RAS viral oncogene homolog (NRAS) |
2
20%
|
4
44.4%
|
6
31.6%
|
| Other/Unknown |
5
50%
|
3
33.3%
|
8
42.1%
|
| Prior Treatment (Count of Participants) | |||
| Anti-PD-1 |
10
100%
|
9
100%
|
19
100%
|
| Other |
3
30%
|
1
11.1%
|
4
21.1%
|
| Best response to prior anti-PD-1 treatment (Count of Participants) | |||
| Stable Disease |
0
0%
|
1
11.1%
|
1
5.3%
|
| Progressive Disease |
9
90%
|
6
66.7%
|
15
78.9%
|
| Unknown |
1
10%
|
2
22.2%
|
3
15.8%
|
| Median lactate dehydrogenase (units/L) [Median (Full Range) ] | |||
| Median (Full Range) [units/L] |
214
|
208
|
211
|
| Median time since last anti-PD-1 treatment (weeks) [Median (Full Range) ] | |||
| Median (Full Range) [weeks] |
4.3
|
6.0
|
5.1
|
Outcome Measures
| Title | Overall Response Rate (ORR) as Defined by RECIST v1.1 at Week 18 |
|---|---|
| Description | Overall Response Rate was defined as any participant who had a Complete Response (CR) or Partial Response (PR) as defined by RECIST v1.1 by week 18 of treatment. |
| Time Frame | Week 18 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy-Evaluable Population. The efficacy-evaluable population includes all participants who were randomly allocated to receive either combination ipilimumab/nivolumab or ipilimumab alone and received at least one dose of any study intervention (ipilimumab or nivolumab). For analyses based on this population, participant treatment groups are defined according to the treatment that was assigned at randomization. |
| Arm/Group Title | Ipilimumab and Nivolumab | Ipilimumab |
|---|---|---|
| Arm/Group Description | For patients in the combination arm, nivolumab will first be administered intravenously at a dose of 1 mg/kg of body weight over a period of 60 minutes, once every 3 weeks for four doses. Thirty minutes after the completion of each nivolumab infusion, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes. ipilimumab nivolumab | In the ipilimumab monotherapy group, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes once every 3 weeks for four doses. ipilimumab |
| Measure Participants | 10 | 9 |
| Number (95% Confidence Interval) [percentage of participants] |
20
200%
|
56
622.2%
|
| Title | Disease Control Rate (DCR) Status at Week 18 |
|---|---|
| Description | Disease Control Rate was defined as any participant who achieved a complete response (CR), partial response (PR), or who remained stable (SD) as defined in Recist v1.1 at week 18. |
| Time Frame | Week 18 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy-Evaluable Population. The efficacy-evaluable population includes all participants who were randomly allocated to receive either combination ipilimumab/nivolumab or ipilimumab alone and received at least one dose of any study intervention (ipilimumab or nivolumab). For analyses based on this population, participant treatment groups are defined according to the treatment that was assigned at randomization. |
| Arm/Group Title | Ipilimumab and Nivolumab | Ipilimumab |
|---|---|---|
| Arm/Group Description | For patients in the combination arm, nivolumab will first be administered intravenously at a dose of 1 mg/kg of body weight over a period of 60 minutes, once every 3 weeks for four doses. Thirty minutes after the completion of each nivolumab infusion, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes. ipilimumab nivolumab | In the ipilimumab monotherapy group, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes once every 3 weeks for four doses. ipilimumab |
| Measure Participants | 10 | 9 |
| Number (95% Confidence Interval) [percentage of participants] |
60
600%
|
67
744.4%
|
| Title | Time to Treatment Failure (TTF) |
|---|---|
| Description | Time to Treatment Failure is defined as the time from treatment initiation until the participant starts a subsequent therapy or death, whichever comes first. |
| Time Frame | The time from treatment initiation until a subsequent therapy is started or death. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy-Evaluable Population. The efficacy-evaluable population includes all participants who were randomly allocated to receive either combination ipilimumab/nivolumab or ipilimumab alone and received at least one dose of any study intervention (ipilimumab or nivolumab). For analyses based on this population, participant treatment groups are defined according to the treatment that was assigned at randomization. |
| Arm/Group Title | Ipilimumab and Nivolumab | Ipilimumab |
|---|---|---|
| Arm/Group Description | For patients in the combination arm, nivolumab will first be administered intravenously at a dose of 1 mg/kg of body weight over a period of 60 minutes, once every 3 weeks for four doses. Thirty minutes after the completion of each nivolumab infusion, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes. ipilimumab nivolumab | In the ipilimumab monotherapy group, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes once every 3 weeks for four doses. ipilimumab |
| Measure Participants | 10 | 9 |
| Median (95% Confidence Interval) [months] |
26.9
|
13.6
|
| Title | Overall Survival (OS) |
|---|---|
| Description | Overall Survival is defined as the time of treatment initiation to death by any cause |
| Time Frame | Death |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy-Evaluable Population. The efficacy-evaluable population includes all participants who were randomly allocated to receive either combination ipilimumab/nivolumab or ipilimumab alone and received at least one dose of any study intervention (ipilimumab or nivolumab). For analyses based on this population, participant treatment groups are defined according to the treatment that was assigned at randomization. |
| Arm/Group Title | Ipilimumab and Nivolumab | Ipilimumab |
|---|---|---|
| Arm/Group Description | For patients in the combination arm, nivolumab will first be administered intravenously at a dose of 1 mg/kg of body weight over a period of 60 minutes, once every 3 weeks for four doses. Thirty minutes after the completion of each nivolumab infusion, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes. ipilimumab nivolumab | In the ipilimumab monotherapy group, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes once every 3 weeks for four doses. ipilimumab |
| Measure Participants | 10 | 9 |
| Count of Participants [Participants] |
2
20%
|
1
11.1%
|
| Title | Number of Participants With Grade 3 or 4 Adverse Events |
|---|---|
| Description | The occurrence of Grade 3 and Grade 4 adverse events (AE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. |
| Time Frame | AE were monitored during each treatment cycle and could be reported until 30 days after the last dose of study treatment had been administered. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety-Evaluable Population. The safety-evaluable population includes all participants who received at least one dose of any study intervention. For analyses based on this population, participant treatment groups will be defined according to the treatment that was assigned at randomization. However, if a participant received the incorrect study drug for the entire period of treatment, the participant's treatment group will be defined as the treatment the participant actually received. |
| Arm/Group Title | Ipilimumab and Nivolumab | Ipilimumab |
|---|---|---|
| Arm/Group Description | For patients in the combination arm, nivolumab will first be administered intravenously at a dose of 1 mg/kg of body weight over a period of 60 minutes, once every 3 weeks for four doses. Thirty minutes after the completion of each nivolumab infusion, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes. ipilimumab nivolumab | In the ipilimumab monotherapy group, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes once every 3 weeks for four doses. ipilimumab |
| Measure Participants | 10 | 9 |
| Count of Participants [Participants] |
4
40%
|
5
55.6%
|
| Title | Disease Control Rate (DCR) Status at Week 12 |
|---|---|
| Description | Disease Control Rate was defined as any participant who achieved a complete response (CR), partial response (PR), or who remained stable (SD) as defined in Recist v1.1 at week 12. |
| Time Frame | Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy-Evaluable Population. The efficacy-evaluable population includes all participants who were randomly allocated to receive either combination ipilimumab/nivolumab or ipilimumab alone and received at least one dose of any study intervention (ipilimumab or nivolumab). For analyses based on this population, participant treatment groups are defined according to the treatment that was assigned at randomization. |
| Arm/Group Title | Ipilimumab and Nivolumab | Ipilimumab |
|---|---|---|
| Arm/Group Description | For patients in the combination arm, nivolumab will first be administered intravenously at a dose of 1 mg/kg of body weight over a period of 60 minutes, once every 3 weeks for four doses. Thirty minutes after the completion of each nivolumab infusion, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes. ipilimumab nivolumab | In the ipilimumab monotherapy group, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes once every 3 weeks for four doses. ipilimumab |
| Measure Participants | 10 | 9 |
| Number (95% Confidence Interval) [Percentage of participants] |
60.0
600%
|
55.6
617.8%
|
Adverse Events
| Time Frame | Adverse events were monitored during each cycle. Adverse events were reported until 30 days after the last dose of study treatment had been administered. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Ipilimumab and Nivolumab | Ipilimumab | ||
| Arm/Group Description | For patients in the combination arm, nivolumab will first be administered intravenously at a dose of 1 mg/kg of body weight over a period of 60 minutes, once every 3 weeks for four doses. Thirty minutes after the completion of each nivolumab infusion, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes. ipilimumab nivolumab | In the ipilimumab monotherapy group, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes once every 3 weeks for four doses. ipilimumab | ||
All Cause Mortality |
||||
| Ipilimumab and Nivolumab | Ipilimumab | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/10 (20%) | 1/9 (11.1%) | ||
Serious Adverse Events |
||||
| Ipilimumab and Nivolumab | Ipilimumab | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/10 (20%) | 4/9 (44.4%) | ||
| Cardiac disorders | ||||
| Pericardial effusion | 1/10 (10%) | 0/9 (0%) | ||
| Endocrine disorders | ||||
| Adrenal insufficiency | 0/10 (0%) | 1/9 (11.1%) | ||
| Gastrointestinal disorders | ||||
| Colitis | 0/10 (0%) | 2/9 (22.2%) | ||
| Diarrhoea | 1/10 (10%) | 1/9 (11.1%) | ||
| Abdominal pain | 0/10 (0%) | 1/9 (11.1%) | ||
| Vomiting | 1/10 (10%) | 0/9 (0%) | ||
| Nausea | 1/10 (10%) | 1/9 (11.1%) | ||
| Infections and infestations | ||||
| Urinary tract infection | 0/10 (0%) | 1/9 (11.1%) | ||
| Injury, poisoning and procedural complications | ||||
| Hip fracture | 0/10 (0%) | 1/9 (11.1%) | ||
| Investigations | ||||
| Neutrophil count decreased | 0/10 (0%) | 1/9 (11.1%) | ||
| White blood cell count decreased | 0/10 (0%) | 1/9 (11.1%) | ||
| Nervous system disorders | ||||
| Headache | 0/10 (0%) | 1/9 (11.1%) | ||
| Psychiatric disorders | ||||
| Confusional state | 0/10 (0%) | 2/9 (22.2%) | ||
| Reproductive system and breast disorders | ||||
| Pleural effusion | 1/10 (10%) | 0/9 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Dyspnoea | 1/10 (10%) | 0/9 (0%) | ||
| Vascular disorders | ||||
| Hypertension | 0/10 (0%) | 1/9 (11.1%) | ||
| Hypotension | 1/10 (10%) | 0/9 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Ipilimumab and Nivolumab | Ipilimumab | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 10/10 (100%) | 9/9 (100%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 1/10 (10%) | 1/9 (11.1%) | ||
| Cardiac disorders | ||||
| Bundle branch block left | 0/10 (0%) | 1/9 (11.1%) | ||
| Sinus bradycardia | 0/10 (0%) | 1/9 (11.1%) | ||
| Sinus tachycardia | 0/10 (0%) | 1/9 (11.1%) | ||
| Ventricular tachycardia | 1/10 (10%) | 0/9 (0%) | ||
| Endocrine disorders | ||||
| Hypophysitis | 3/10 (30%) | 1/9 (11.1%) | ||
| Hypothyroidism | 1/10 (10%) | 1/9 (11.1%) | ||
| Hyperthyroidism | 1/10 (10%) | 0/9 (0%) | ||
| Eye disorders | ||||
| Vision blurred | 1/10 (10%) | 0/9 (0%) | ||
| Gastrointestinal disorders | ||||
| Diarrhoea | 5/10 (50%) | 4/9 (44.4%) | ||
| Abdominal pain | 2/10 (20%) | 4/9 (44.4%) | ||
| Nausea | 5/10 (50%) | 0/9 (0%) | ||
| Constipation | 2/10 (20%) | 1/9 (11.1%) | ||
| Dry mouth | 1/10 (10%) | 2/9 (22.2%) | ||
| Vomiting | 1/10 (10%) | 1/9 (11.1%) | ||
| Abdominal distension | 1/10 (10%) | 0/9 (0%) | ||
| Abdominal pain upper | 0/10 (0%) | 1/9 (11.1%) | ||
| Colitis | 1/10 (10%) | 0/9 (0%) | ||
| Faecaloma | 0/10 (0%) | 1/9 (11.1%) | ||
| Flatulence | 0/10 (0%) | 1/9 (11.1%) | ||
| Gastrooesophageal reflux disease | 0/10 (0%) | 1/9 (11.1%) | ||
| Haemorrhoids | 1/10 (10%) | 0/9 (0%) | ||
| General disorders | ||||
| Pyrexia | 3/10 (30%) | 3/9 (33.3%) | ||
| Fatigue | 2/10 (20%) | 3/9 (33.3%) | ||
| Chills | 0/10 (0%) | 2/9 (22.2%) | ||
| Oedema peripheral | 1/10 (10%) | 1/9 (11.1%) | ||
| Influenza like illness | 0/10 (0%) | 1/9 (11.1%) | ||
| Hepatobiliary disorders | ||||
| Biliary colic | 0/10 (0%) | 1/9 (11.1%) | ||
| Cholelithiasis | 0/10 (0%) | 1/9 (11.1%) | ||
| Infections and infestations | ||||
| Skin infection | 1/10 (10%) | 1/9 (11.1%) | ||
| Lung infection | 1/10 (10%) | 0/9 (0%) | ||
| Oral herpes | 1/10 (10%) | 0/9 (0%) | ||
| Proteus infection | 1/10 (10%) | 0/9 (0%) | ||
| Sinusitis | 0/10 (0%) | 1/9 (11.1%) | ||
| Injury, poisoning and procedural complications | ||||
| Post procedural swelling | 1/10 (10%) | 0/9 (0%) | ||
| Investigations | ||||
| Alanine aminotransferase increased | 5/10 (50%) | 2/9 (22.2%) | ||
| Aspartate aminotransferase increased | 4/10 (40%) | 1/9 (11.1%) | ||
| White blood cell count decreased | 2/10 (20%) | 2/9 (22.2%) | ||
| Platelet count decreased | 2/10 (20%) | 1/9 (11.1%) | ||
| Weight decreased | 1/10 (10%) | 2/9 (22.2%) | ||
| Neutrophil count decreased | 1/10 (10%) | 1/9 (11.1%) | ||
| Amylase increased | 0/10 (0%) | 1/9 (11.1%) | ||
| Blood alkaline phosphatase increased | 0/10 (0%) | 1/9 (11.1%) | ||
| Blood bilirubin increased | 1/10 (10%) | 0/9 (0%) | ||
| Lipase increased | 0/10 (0%) | 1/9 (11.1%) | ||
| Lymphocyte count decreased | 0/10 (0%) | 1/9 (11.1%) | ||
| Metabolism and nutrition disorders | ||||
| Hypoalbuminaemia | 3/10 (30%) | 5/9 (55.6%) | ||
| Hyponatraemia | 2/10 (20%) | 2/9 (22.2%) | ||
| Decreased appetite | 1/10 (10%) | 2/9 (22.2%) | ||
| Hypokalaemia | 1/10 (10%) | 2/9 (22.2%) | ||
| Hypocalcaemia | 0/10 (0%) | 2/9 (22.2%) | ||
| Hypercalcaemia | 0/10 (0%) | 1/9 (11.1%) | ||
| Hyperglycaemia | 0/10 (0%) | 1/9 (11.1%) | ||
| Hyperkalaemia | 0/10 (0%) | 1/9 (11.1%) | ||
| Hypernatraemia | 1/10 (10%) | 0/9 (0%) | ||
| Hypoglycaemia | 1/10 (10%) | 0/9 (0%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 1/10 (10%) | 2/9 (22.2%) | ||
| Pain in extremity | 0/10 (0%) | 2/9 (22.2%) | ||
| Back pain | 0/10 (0%) | 1/9 (11.1%) | ||
| Myalgia | 0/10 (0%) | 1/9 (11.1%) | ||
| Nervous system disorders | ||||
| Headache | 3/10 (30%) | 1/9 (11.1%) | ||
| Hypoaesthesia | 1/10 (10%) | 0/9 (0%) | ||
| Peripheral sensory neuropathy | 1/10 (10%) | 0/9 (0%) | ||
| Syncope | 0/10 (0%) | 1/9 (11.1%) | ||
| Renal and urinary disorders | ||||
| Pollakiuria | 0/10 (0%) | 1/9 (11.1%) | ||
| Reproductive system and breast disorders | ||||
| Pelvic pain | 0/10 (0%) | 1/9 (11.1%) | ||
| Vulval disorder | 0/10 (0%) | 1/9 (11.1%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 4/10 (40%) | 2/9 (22.2%) | ||
| Nasal congestion | 2/10 (20%) | 2/9 (22.2%) | ||
| Dysphonia | 1/10 (10%) | 0/9 (0%) | ||
| Oropharyngeal pain | 1/10 (10%) | 0/9 (0%) | ||
| Rhonchi | 0/10 (0%) | 1/9 (11.1%) | ||
| Upper-airway cough syndrome | 0/10 (0%) | 1/9 (11.1%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Pruritus | 7/10 (70%) | 5/9 (55.6%) | ||
| Rash maculo-papular | 5/10 (50%) | 3/9 (33.3%) | ||
| Dry skin | 0/10 (0%) | 1/9 (11.1%) | ||
| Erythema multiforme | 1/10 (10%) | 0/9 (0%) | ||
| Hair color changes | 0/10 (0%) | 1/9 (11.1%) | ||
| Lichenoid keratosis | 1/10 (10%) | 0/9 (0%) | ||
| Skin hypopigmentation | 1/10 (10%) | 0/9 (0%) | ||
| Stasis dermatitis | 0/10 (0%) | 1/9 (11.1%) | ||
| Vascular disorders | ||||
| Hypertension | 4/10 (40%) | 4/9 (44.4%) | ||
| Hypotension | 1/10 (10%) | 0/9 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Trial Site and/or Co-Principal Investigators may publish or present Study Data and other results of the Study from the Trial Site individually upon the first to occur of: (i) twelve (12) months after conclusion, abandonment, or termination of the Study at all Affiliated Research Institutions, or (ii) after Parker Institute for Cancer Immunotherapy [PICI] confirms in writing there will not be a multi-site Study publication.
Results Point of Contact
| Name/Title | Jennifer Ayran |
|---|---|
| Organization | Parker Institute for Cancer Immunotherapy |
| Phone | 628-899-7623 |
| jayran@parkerici.org |
- PICI0001
- 16-043