Carcinoma, Renal Cell
Conditions
Keywords
localized, resected, adjuvant, Renal Cell Carcinoma, Kidney Cancer, Nephrectomy, Clear cell, High Risk of Relapse/Recurrence
Brief summary
The purpose of this study is to determine whether nivolmab alone or the combination of nivolumab and ipilimumab versus placebo, is safe and effective for delaying or preventing recurrence of cancer in participants who have experienced partial or entire removal of a kidney.
Detailed description
The study has two primary endpoints. The first primary completion date is anticipated to be reached July 2022 (DFS in Part A). The second primary completion date is anticipated to be reached July 2024 (DFS in Part B).
Interventions
BIOLOGICALnivolumab
Specified dose on specified days
BIOLOGICALipilimumab
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Kidney tumor has been completely resected with negative surgical margins obtained. The randomization must occur greater than 4 weeks and less than (or equal to) 12 weeks from the date of nephrectomy * Pathologic tumor, node, and metastasis (TNM) staging meeting one of the following: pT2a, G3 or G4, N0 M0; pT2b, G any, N0 M0; pT3, (a, b, c), G any, N0 M0; pT4, G any, N0 M0; pT any, G any, N1 M0 * Post-nephrectomy tumor shows renal cell cancer (RCC) with a predominantly clear cell histology, including participants with sarcomatoid features * Participants must have no clinical or radiological evidence of macroscopic residual disease or distant metastases after nephrectomy * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1 * Women must agree to follow methods of contraception, if applicable
Exclusion criteria
* Participants with an active known or suspected autoimmune disease * Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) * Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways * Any severe or serious, acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation * History of allergy or hypersensitivity to study drug components * Participants with a condition requiring systemic treatment with corticosteroids * Participants who have received a live/attenuated vaccine within 30 days of first treatment Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-Free Survival (DFS) by BICR - Treatment Part A and B | From randomization to development of local disease recurrence, distance metastasis, or death, whichever came first (up to approximately 72 months) | Disease-Free Survival (DFS) is defined as the time from randomization to development of local disease recurrence (ie, recurrence of primary tumor in situ or occurrence of a secondary renal cell carcinoma (RCC) primary cancer), distance metastasis, or death, whichever came first per Blinded Independent Central Review (BICR) based on Kaplan-Meier estimates. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) Rate (5 Years) - Treatment Part A and B | At 5 years | Overall survival rate at 5 years is defined as the percentage of participants who are alive at 5 years. |
| Disease-Free Survival (DFS) Per BICR in Contemporaneously Randomized Combination and Monotherapy Participants - Treatment Part B | From randomization to development of local disease recurrence, distance metastasis, or death, whichever came first (up to approximately 72 months) | Disease-Free Survival (DFS) is defined as the time from randomization to development of local disease recurrence (ie, recurrence of primary tumor in situ or occurrence of a secondary renal cell carcinoma (RCC) primary cancer), distance metastasis, or death, whichever came first per Blinded Independent Central Review (BICR) based on Kaplan-Meier estimates. |
| Overall Survival (OS) in the Contemporaneously Randomized Combination and Monotherapy Participants - Treatment Part B | From randomization to the date of death (up to approximately 72 months) | Overall Survival (OS) is defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS will be censored on the last date the participants was known to be alive. Based on Kaplan-Meier estimates |
| The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part A | From first dose to 30 days post last dose (up to approximately 40 weeks) | An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Graded according to NCI CTCAE (Version 4) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death. |
| The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part B | From first dose to 30 days post last dose (up to approximately 40 weeks) | An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Graded according to NCI CTCAE (Version 4) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death. |
| Overall Survival (OS) - Treatment Part A and B | From randomization to the date of death (up to approximately 72 months) | Overall Survival (OS) is defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS will be censored on the last date the participants was known to be alive. Based on Kaplan-Meier estimates. |
| The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part B | From first dose to 100 days post last dose (up to approximately 50 weeks) | An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Graded according to NCI CTCAE (Version 4) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death. |
| The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A | From first dose to 30 days post last dose (up to approximately 40 weeks) | Graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE, Version 4.0\] where grade 3 = severe, and grade 4 = life-threatening. Baseline evaluations are defined as evaluations or events that occur before the date and time of the first dose of study treatment. |
| The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | From first dose to 30 days post last dose (up to approximately 40 weeks) | Graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE, Version 4.0\] where grade 3 = severe, and grade 4 = life-threatening. Baseline evaluations are defined as evaluations or events that occur before the date and time of the first dose of study treatment. |
| The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A | From first dose to 100 days post last dose (up to approximately 50 weeks) | Graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE, Version 4.0\] where grade 3 = severe, and grade 4 = life-threatening. Baseline evaluations are defined as evaluations or events that occur before the date and time of the first dose of study treatment. |
| The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | From first dose to 100 days post last dose (up to approximately 50 weeks) | Graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE, Version 4.0\] where grade 3 = severe, and grade 4 = life-threatening. Baseline evaluations are defined as evaluations or events that occur before the date and time of the first dose of study treatment. |
| The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part A | From first dose to 100 days post last dose (up to approximately 50 weeks) | An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Graded according to NCI CTCAE (Version 4) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death. |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czechia, France, Germany, Italy, Japan, Mexico, Netherlands, Poland, Romania, Russia, Singapore, Spain, Switzerland, Turkey (Türkiye), United Kingdom, United States
Participant flow
Pre-assignment details
Part A and B participants are separately randomized and treated.
Participants by arm
| Arm | Count |
|---|---|
| Treatment Part A: Nivo + Ipi Nivolumab 240 mg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks (or every third nivolumab dose if dosing is delayed). | 405 |
| Treatment Part A: Placebo Placebo infusions at the same frequency of nivolumab and ipilimumab infusions. | 411 |
| Treatment Part B: Nivo + Ipi Nivolumab 240 mg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks (or every third nivolumab dose if dosing is delayed). | 206 |
| Treatment Part B: Placebo Placebo infusions at the same frequency of nivolumab and ipilimumab infusions. | 208 |
| Treatment Part B: Nivo Nivolumab 240 mg every 2 weeks and ipilimumab Placebo every 6 weeks (or every third nivolumab dose if dosing is delayed). | 411 |
| Total | 1,641 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Randomization | Other reasons | 1 | 0 | 0 | 0 | 0 |
| Randomization | Participant no longer meets study criteria | 0 | 3 | 1 | 1 | 3 |
| Randomization | Participants withdrew consent | 0 | 1 | 1 | 0 | 0 |
| Treatment Part A | Adverse event unrelated to study drug | 9 | 4 | 0 | 0 | 0 |
| Treatment Part A | Death | 1 | 0 | 0 | 0 | 0 |
| Treatment Part A | Disease recurrence | 10 | 20 | 0 | 0 | 0 |
| Treatment Part A | Lost to Follow-up | 0 | 1 | 0 | 0 | 0 |
| Treatment Part A | Other reasons | 11 | 8 | 0 | 0 | 0 |
| Treatment Part A | Participant request to discontinue treatment | 9 | 4 | 0 | 0 | 0 |
| Treatment Part A | Participant withdrew consent | 2 | 4 | 0 | 0 | 0 |
| Treatment Part A | Poor/non-compliance | 1 | 0 | 0 | 0 | 0 |
| Treatment Part A | Pregnancy | 0 | 1 | 0 | 0 | 0 |
| Treatment Part A | Study Drug Toxicity | 132 | 5 | 0 | 0 | 0 |
| Treatment Part B | Adverse event unrelated to study drug | 0 | 0 | 5 | 2 | 12 |
| Treatment Part B | Death | 0 | 0 | 1 | 0 | 0 |
| Treatment Part B | Disease recurrence | 0 | 0 | 6 | 12 | 10 |
| Treatment Part B | Lost to Follow-up | 0 | 0 | 0 | 1 | 0 |
| Treatment Part B | Other reasons | 0 | 0 | 3 | 1 | 5 |
| Treatment Part B | Participants request to discontinue study treatment | 0 | 0 | 6 | 4 | 6 |
| Treatment Part B | Participant withdrew consent | 0 | 0 | 1 | 1 | 2 |
| Treatment Part B | Poor/non-compliance | 0 | 0 | 1 | 1 | 1 |
| Treatment Part B | Study drug toxicity | 0 | 0 | 63 | 3 | 45 |
Baseline characteristics
| Characteristic | Treatment Part A: Nivo + Ipi | Treatment Part A: Placebo | Treatment Part B: Nivo + Ipi | Treatment Part B: Placebo | Treatment Part B: Nivo | Total |
|---|---|---|---|---|---|---|
| Age, Customized < 65 | 293 Participants | 301 Participants | 132 Participants | 137 Participants | 279 Participants | 1142 Participants |
| Age, Customized >= 65 AND < 75 | 93 Participants | 91 Participants | 64 Participants | 60 Participants | 108 Participants | 416 Participants |
| Age, Customized >= 75 AND < 85 | 19 Participants | 19 Participants | 10 Participants | 11 Participants | 23 Participants | 82 Participants |
| Age, Customized >= 85 | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 41 Participants | 44 Participants | 26 Participants | 34 Participants | 67 Participants | 212 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 189 Participants | 197 Participants | 93 Participants | 79 Participants | 157 Participants | 715 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 175 Participants | 170 Participants | 87 Participants | 95 Participants | 187 Participants | 714 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 3 Participants | 5 Participants | 3 Participants | 14 Participants | 25 Participants |
| Race (NIH/OMB) Asian | 93 Participants | 65 Participants | 20 Participants | 26 Participants | 50 Participants | 254 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 6 Participants | 0 Participants | 1 Participants | 4 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 14 Participants | 8 Participants | 9 Participants | 12 Participants | 49 Participants |
| Race (NIH/OMB) White | 303 Participants | 322 Participants | 173 Participants | 169 Participants | 331 Participants | 1298 Participants |
| Sex: Female, Male Female | 119 Participants | 117 Participants | 59 Participants | 67 Participants | 106 Participants | 468 Participants |
| Sex: Female, Male Male | 286 Participants | 294 Participants | 147 Participants | 141 Participants | 305 Participants | 1173 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 65 / 611 | 55 / 619 | 22 / 411 |
| other Total, other adverse events | 544 / 608 | 469 / 614 | 325 / 408 |
| serious Total, serious adverse events | 196 / 608 | 49 / 614 | 56 / 408 |
Outcome results
Primary
Disease-Free Survival (DFS) by BICR - Treatment Part A and B
Disease-Free Survival (DFS) is defined as the time from randomization to development of local disease recurrence (ie, recurrence of primary tumor in situ or occurrence of a secondary renal cell carcinoma (RCC) primary cancer), distance metastasis, or death, whichever came first per Blinded Independent Central Review (BICR) based on Kaplan-Meier estimates.
Time frame: From randomization to development of local disease recurrence, distance metastasis, or death, whichever came first (up to approximately 72 months)
Population: All randomized participants in Treatment Part A (Nivo + Ipi and Placebo Arms) and Treatment Part B (Placebo and Nivo Arms). The Nivo + Ipi Arm was prespecified to be excluded from the endpoint objective for Treatment Part B.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment Part A: Nivo + Ipi | Disease-Free Survival (DFS) by BICR - Treatment Part A and B | NA Months |
| Treatment Part A: Placebo | Disease-Free Survival (DFS) by BICR - Treatment Part A and B | NA Months |
| Treatment Part B: Placebo | Disease-Free Survival (DFS) by BICR - Treatment Part A and B | NA Months |
| Treatment Part B: Nivo | Disease-Free Survival (DFS) by BICR - Treatment Part A and B | NA Months |
p-value: 0.667695% CI: [0.75, 1.2]Log Rank
p-value: 0.655695% CI: [0.67, 1.28]Log Rank
Secondary
Disease-Free Survival (DFS) Per BICR in Contemporaneously Randomized Combination and Monotherapy Participants - Treatment Part B
Disease-Free Survival (DFS) is defined as the time from randomization to development of local disease recurrence (ie, recurrence of primary tumor in situ or occurrence of a secondary renal cell carcinoma (RCC) primary cancer), distance metastasis, or death, whichever came first per Blinded Independent Central Review (BICR) based on Kaplan-Meier estimates.
Time frame: From randomization to development of local disease recurrence, distance metastasis, or death, whichever came first (up to approximately 72 months)
Population: All randomized Nivo + Ipi and Nivo participants in Treatment Part B. Prespecified to be collected for Treatment Part B only. The Placebo Arm was prespecified to be excluded from the endpoint objective.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment Part A: Nivo + Ipi | Disease-Free Survival (DFS) Per BICR in Contemporaneously Randomized Combination and Monotherapy Participants - Treatment Part B | NA Months |
| Treatment Part A: Placebo | Disease-Free Survival (DFS) Per BICR in Contemporaneously Randomized Combination and Monotherapy Participants - Treatment Part B | NA Months |
95% CI: [0.89, 1.67]
Secondary
Overall Survival (OS) in the Contemporaneously Randomized Combination and Monotherapy Participants - Treatment Part B
Overall Survival (OS) is defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS will be censored on the last date the participants was known to be alive. Based on Kaplan-Meier estimates
Time frame: From randomization to the date of death (up to approximately 72 months)
Population: All randomized Nivo + Ipi and Nivo participants in Treatment Part B. Prespecified to be collected for Treatment Part B only. The Placebo Arm was prespecified to be excluded from the endpoint objective.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment Part A: Nivo + Ipi | Overall Survival (OS) in the Contemporaneously Randomized Combination and Monotherapy Participants - Treatment Part B | NA Months |
| Treatment Part A: Placebo | Overall Survival (OS) in the Contemporaneously Randomized Combination and Monotherapy Participants - Treatment Part B | NA Months |
95% CI: [0.33, 1.68]
Secondary
Overall Survival (OS) Rate (5 Years) - Treatment Part A and B
Overall survival rate at 5 years is defined as the percentage of participants who are alive at 5 years.
Time frame: At 5 years
Population: All randomized participants in Treatment Part A (Nivo + Ipi and Placebo Arms). Data was not collected for Treatment Part B.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Part A: Nivo + Ipi | Overall Survival (OS) Rate (5 Years) - Treatment Part A and B | 85.0 Percent of participants |
| Treatment Part A: Placebo | Overall Survival (OS) Rate (5 Years) - Treatment Part A and B | 87.2 Percent of participants |
Secondary
Overall Survival (OS) - Treatment Part A and B
Overall Survival (OS) is defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS will be censored on the last date the participants was known to be alive. Based on Kaplan-Meier estimates.
Time frame: From randomization to the date of death (up to approximately 72 months)
Population: All randomized participants in Treatment Part A (Nivo + Ipi and Placebo Arms) and Treatment Part B (Placebo and Nivo Arms). The Nivo + Ipi Arm was prespecified to be excluded from the endpoint objective for Treatment Part B.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment Part A: Nivo + Ipi | Overall Survival (OS) - Treatment Part A and B | NA Months |
| Treatment Part A: Placebo | Overall Survival (OS) - Treatment Part A and B | NA Months |
| Treatment Part B: Placebo | Overall Survival (OS) - Treatment Part A and B | NA Months |
| Treatment Part B: Nivo | Overall Survival (OS) - Treatment Part A and B | NA Months |
Comparison: Treatment Part Ap-value: 0.243695% CI: [0.85, 1.85]Log Rank
Comparison: Treatment Part Bp-value: 0.4595% CI: [0.61, 3.07]Log Rank
Secondary
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A
Graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE, Version 4.0\] where grade 3 = severe, and grade 4 = life-threatening. Baseline evaluations are defined as evaluations or events that occur before the date and time of the first dose of study treatment.
Time frame: From first dose to 100 days post last dose (up to approximately 50 weeks)
Population: All treated participants in Treatment Part A with a CTC graded laboratory result for the given parameter from both baseline and on-treatment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A | HEMOGLOBIN | 1 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A | PLATELET COUNT | 1 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A | LEUKOCYTES, LOCAL LAB | 0 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A | LYMPHOCYTES (ABSOLUTE), TOTAL | 11 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A | ABSOLUTE NEUTROPHIL COUNT | 2 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A | ALKALINE PHOSPHATASE, LOCAL LAB | 5 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A | ASPARTATE AMINOTRANSFERASE, LOCAL LAB | 17 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A | ALANINE AMINOTRANSFERASE, LOCAL LAB | 20 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A | BILIRUBIN, TOTAL, LOCAL LAB | 3 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A | CREATININE, LOCAL LAB | 4 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A | HYPERNATREMIA | 0 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A | HYPONATREMIA | 30 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A | HYPERKALEMIA | 6 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A | HYPOKALEMIA | 5 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A | HYPERCALCEMIA | 3 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A | HYPOCALCEMIA | 1 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A | HYPERMAGNESEMIA | 1 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A | HYPOMAGNESEMIA | 1 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A | HYPERGLYCEMIA | 7 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A | HYPOGLYCEMIA | 1 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A | HYPOMAGNESEMIA | 0 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A | HEMOGLOBIN | 1 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A | HYPERNATREMIA | 0 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A | PLATELET COUNT | 0 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A | HYPOCALCEMIA | 0 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A | LEUKOCYTES, LOCAL LAB | 0 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A | HYPONATREMIA | 7 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A | LYMPHOCYTES (ABSOLUTE), TOTAL | 3 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A | HYPOGLYCEMIA | 0 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A | ABSOLUTE NEUTROPHIL COUNT | 0 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A | HYPERKALEMIA | 5 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A | ALKALINE PHOSPHATASE, LOCAL LAB | 0 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A | HYPERMAGNESEMIA | 1 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A | ASPARTATE AMINOTRANSFERASE, LOCAL LAB | 3 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A | HYPOKALEMIA | 1 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A | ALANINE AMINOTRANSFERASE, LOCAL LAB | 6 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A | HYPERGLYCEMIA | 1 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A | BILIRUBIN, TOTAL, LOCAL LAB | 0 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A | HYPERCALCEMIA | 0 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A | CREATININE, LOCAL LAB | 1 Participants |
Secondary
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B
Graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE, Version 4.0\] where grade 3 = severe, and grade 4 = life-threatening. Baseline evaluations are defined as evaluations or events that occur before the date and time of the first dose of study treatment.
Time frame: From first dose to 100 days post last dose (up to approximately 50 weeks)
Population: All treated participants in Treatment Part B with a CTC graded laboratory result for the given parameter from both baseline and on-treatment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | HYPERCALCEMIA | 1 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | ALANINE AMINOTRANSFERASE, LOCAL LAB | 9 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | HEMOGLOBIN | 2 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | HYPOKALEMIA | 1 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | BILIRUBIN, TOTAL, LOCAL LAB | 0 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | LYMPHOCYTES (ABSOLUTE), TOTAL | 3 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | HYPERKALEMIA | 1 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | CREATININE, LOCAL LAB | 4 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | HYPOGLYCEMIA | 0 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | HYPONATREMIA | 12 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | HYPERNATREMIA | 0 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | HYPOMAGNESEMIA | 0 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | ABSOLUTE NEUTROPHIL COUNT | 0 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | HYPERGLYCEMIA | 3 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | HYPERMAGNESEMIA | 3 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | ALKALINE PHOSPHATASE, LOCAL LAB | 2 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | LEUKOCYTES, LOCAL LAB | 0 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | HYPOCALCEMIA | 0 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | ASPARTATE AMINOTRANSFERASE, LOCAL LAB | 6 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | PLATELET COUNT | 0 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | HYPOMAGNESEMIA | 1 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | HEMOGLOBIN | 3 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | PLATELET COUNT | 1 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | LEUKOCYTES, LOCAL LAB | 0 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | LYMPHOCYTES (ABSOLUTE), TOTAL | 2 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | ABSOLUTE NEUTROPHIL COUNT | 0 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | ALKALINE PHOSPHATASE, LOCAL LAB | 1 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | ASPARTATE AMINOTRANSFERASE, LOCAL LAB | 4 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | ALANINE AMINOTRANSFERASE, LOCAL LAB | 3 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | BILIRUBIN, TOTAL, LOCAL LAB | 1 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | CREATININE, LOCAL LAB | 0 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | HYPERNATREMIA | 0 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | HYPONATREMIA | 1 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | HYPERKALEMIA | 2 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | HYPOKALEMIA | 2 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | HYPERCALCEMIA | 0 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | HYPOCALCEMIA | 1 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | HYPERMAGNESEMIA | 2 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | HYPERGLYCEMIA | 1 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | HYPOGLYCEMIA | 0 Participants |
| Treatment Part B: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | PLATELET COUNT | 0 Participants |
| Treatment Part B: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | HYPOKALEMIA | 2 Participants |
| Treatment Part B: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | ASPARTATE AMINOTRANSFERASE, LOCAL LAB | 6 Participants |
| Treatment Part B: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | HYPOGLYCEMIA | 1 Participants |
| Treatment Part B: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | HYPERCALCEMIA | 1 Participants |
| Treatment Part B: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | ALKALINE PHOSPHATASE, LOCAL LAB | 0 Participants |
| Treatment Part B: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | HYPERGLYCEMIA | 4 Participants |
| Treatment Part B: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | HYPOCALCEMIA | 1 Participants |
| Treatment Part B: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | ABSOLUTE NEUTROPHIL COUNT | 2 Participants |
| Treatment Part B: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | HEMOGLOBIN | 1 Participants |
| Treatment Part B: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | HYPERMAGNESEMIA | 3 Participants |
| Treatment Part B: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | LYMPHOCYTES (ABSOLUTE), TOTAL | 7 Participants |
| Treatment Part B: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | HYPERNATREMIA | 0 Participants |
| Treatment Part B: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | CREATININE, LOCAL LAB | 3 Participants |
| Treatment Part B: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | LEUKOCYTES, LOCAL LAB | 2 Participants |
| Treatment Part B: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | HYPONATREMIA | 13 Participants |
| Treatment Part B: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | BILIRUBIN, TOTAL, LOCAL LAB | 0 Participants |
| Treatment Part B: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | HYPOMAGNESEMIA | 1 Participants |
| Treatment Part B: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | HYPERKALEMIA | 4 Participants |
| Treatment Part B: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B | ALANINE AMINOTRANSFERASE, LOCAL LAB | 10 Participants |
Secondary
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A
Graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE, Version 4.0\] where grade 3 = severe, and grade 4 = life-threatening. Baseline evaluations are defined as evaluations or events that occur before the date and time of the first dose of study treatment.
Time frame: From first dose to 30 days post last dose (up to approximately 40 weeks)
Population: All treated participants in Treatment Part A with a CTC graded laboratory result for the given parameter from both baseline and on-treatment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A | HEMOGLOBIN | 1 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A | PLATELET COUNT | 1 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A | LEUKOCYTES, LOCAL LAB | 0 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A | LYMPHOCYTES (ABSOLUTE), TOTAL | 6 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A | ABSOLUTE NEUTROPHIL COUNT | 2 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A | ALKALINE PHOSPHATASE, LOCAL LAB | 3 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A | ASPARTATE AMINOTRANSFERASE, LOCAL LAB | 14 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A | ALANINE AMINOTRANSFERASE, LOCAL LAB | 16 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A | BILIRUBIN, TOTAL, LOCAL LAB | 1 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A | CREATININE, LOCAL LAB | 1 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A | HYPERNATREMIA | 0 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A | HYPONATREMIA | 28 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A | HYPERKALEMIA | 6 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A | HYPOKALEMIA | 3 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A | HYPERCALCEMIA | 3 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A | HYPOCALCEMIA | 1 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A | HYPERMAGNESEMIA | 1 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A | HYPOMAGNESEMIA | 1 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A | HYPERGLYCEMIA | 6 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A | HYPOGLYCEMIA | 1 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A | HYPOMAGNESEMIA | 0 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A | HEMOGLOBIN | 1 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A | HYPERNATREMIA | 0 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A | PLATELET COUNT | 0 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A | HYPOCALCEMIA | 0 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A | LEUKOCYTES, LOCAL LAB | 0 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A | HYPONATREMIA | 7 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A | LYMPHOCYTES (ABSOLUTE), TOTAL | 3 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A | HYPOGLYCEMIA | 0 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A | ABSOLUTE NEUTROPHIL COUNT | 0 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A | HYPERKALEMIA | 5 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A | ALKALINE PHOSPHATASE, LOCAL LAB | 0 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A | HYPERMAGNESEMIA | 1 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A | ASPARTATE AMINOTRANSFERASE, LOCAL LAB | 3 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A | HYPOKALEMIA | 1 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A | ALANINE AMINOTRANSFERASE, LOCAL LAB | 5 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A | HYPERGLYCEMIA | 1 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A | BILIRUBIN, TOTAL, LOCAL LAB | 0 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A | HYPERCALCEMIA | 0 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A | CREATININE, LOCAL LAB | 1 Participants |
Secondary
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B
Graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE, Version 4.0\] where grade 3 = severe, and grade 4 = life-threatening. Baseline evaluations are defined as evaluations or events that occur before the date and time of the first dose of study treatment.
Time frame: From first dose to 30 days post last dose (up to approximately 40 weeks)
Population: All treated participants in Treatment Part B with a CTC graded laboratory result for the given parameter from both baseline and on-treatment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | HYPERCALCEMIA | 1 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | ALANINE AMINOTRANSFERASE, LOCAL LAB | 7 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | HEMOGLOBIN | 0 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | HYPOKALEMIA | 1 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | BILIRUBIN, TOTAL, LOCAL LAB | 0 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | LYMPHOCYTES (ABSOLUTE), TOTAL | 3 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | HYPERKALEMIA | 1 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | CREATININE, LOCAL LAB | 3 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | HYPOGLYCEMIA | 0 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | HYPONATREMIA | 11 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | HYPERNATREMIA | 0 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | HYPOMAGNESEMIA | 0 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | ABSOLUTE NEUTROPHIL COUNT | 0 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | HYPERGLYCEMIA | 3 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | HYPERMAGNESEMIA | 2 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | ALKALINE PHOSPHATASE, LOCAL LAB | 1 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | LEUKOCYTES, LOCAL LAB | 0 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | HYPOCALCEMIA | 0 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | ASPARTATE AMINOTRANSFERASE, LOCAL LAB | 4 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | PLATELET COUNT | 0 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | HYPOMAGNESEMIA | 1 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | HEMOGLOBIN | 3 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | PLATELET COUNT | 1 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | LEUKOCYTES, LOCAL LAB | 0 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | LYMPHOCYTES (ABSOLUTE), TOTAL | 1 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | ABSOLUTE NEUTROPHIL COUNT | 0 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | ALKALINE PHOSPHATASE, LOCAL LAB | 1 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | ASPARTATE AMINOTRANSFERASE, LOCAL LAB | 4 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | ALANINE AMINOTRANSFERASE, LOCAL LAB | 3 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | BILIRUBIN, TOTAL, LOCAL LAB | 1 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | CREATININE, LOCAL LAB | 0 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | HYPERNATREMIA | 0 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | HYPONATREMIA | 1 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | HYPERKALEMIA | 2 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | HYPOKALEMIA | 1 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | HYPERCALCEMIA | 0 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | HYPOCALCEMIA | 1 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | HYPERMAGNESEMIA | 2 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | HYPERGLYCEMIA | 1 Participants |
| Treatment Part A: Placebo | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | HYPOGLYCEMIA | 0 Participants |
| Treatment Part B: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | PLATELET COUNT | 0 Participants |
| Treatment Part B: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | HYPOKALEMIA | 0 Participants |
| Treatment Part B: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | ASPARTATE AMINOTRANSFERASE, LOCAL LAB | 5 Participants |
| Treatment Part B: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | HYPOGLYCEMIA | 1 Participants |
| Treatment Part B: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | HYPERCALCEMIA | 1 Participants |
| Treatment Part B: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | ALKALINE PHOSPHATASE, LOCAL LAB | 0 Participants |
| Treatment Part B: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | HYPERGLYCEMIA | 3 Participants |
| Treatment Part B: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | HYPOCALCEMIA | 0 Participants |
| Treatment Part B: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | ABSOLUTE NEUTROPHIL COUNT | 1 Participants |
| Treatment Part B: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | HEMOGLOBIN | 0 Participants |
| Treatment Part B: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | HYPERMAGNESEMIA | 3 Participants |
| Treatment Part B: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | LYMPHOCYTES (ABSOLUTE), TOTAL | 4 Participants |
| Treatment Part B: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | HYPERNATREMIA | 0 Participants |
| Treatment Part B: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | CREATININE, LOCAL LAB | 0 Participants |
| Treatment Part B: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | LEUKOCYTES, LOCAL LAB | 1 Participants |
| Treatment Part B: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | HYPONATREMIA | 9 Participants |
| Treatment Part B: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | BILIRUBIN, TOTAL, LOCAL LAB | 0 Participants |
| Treatment Part B: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | HYPOMAGNESEMIA | 1 Participants |
| Treatment Part B: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | HYPERKALEMIA | 2 Participants |
| Treatment Part B: Nivo + Ipi | The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B | ALANINE AMINOTRANSFERASE, LOCAL LAB | 8 Participants |
Secondary
The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part A
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Graded according to NCI CTCAE (Version 4) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death.
Time frame: From first dose to 100 days post last dose (up to approximately 50 weeks)
Population: All Treated Participants in Treatment Part A
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Part A: Nivo + Ipi | The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part A | Any Grade AE | 393 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part A | Grade 3-4 AE | 167 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part A | Grade 5 AE | 4 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part A | Any Grade Drug-Related AE | 361 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part A | Grade 3-4 Drug-Related AE | 128 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part A | Grade 5 Drug-Related AE | 2 Participants |
| Treatment Part A: Placebo | The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part A | Grade 3-4 Drug-Related AE | 9 Participants |
| Treatment Part A: Placebo | The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part A | Any Grade AE | 365 Participants |
| Treatment Part A: Placebo | The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part A | Any Grade Drug-Related AE | 230 Participants |
| Treatment Part A: Placebo | The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part A | Grade 3-4 AE | 52 Participants |
| Treatment Part A: Placebo | The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part A | Grade 5 Drug-Related AE | 0 Participants |
| Treatment Part A: Placebo | The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part A | Grade 5 AE | 1 Participants |
Secondary
The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part B
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Graded according to NCI CTCAE (Version 4) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death.
Time frame: From first dose to 100 days post last dose (up to approximately 50 weeks)
Population: All Treated Participants in Treatment Part B
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Part A: Nivo + Ipi | The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part B | Grade 3-4 AE | 68 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part B | Any Grade AE | 196 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part B | Grade 5 Drug-Related AE | 0 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part B | Grade 5 AE | 5 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part B | Grade 3-4 Drug-Related AE | 46 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part B | Any Grade Drug-Related AE | 175 Participants |
| Treatment Part A: Placebo | The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part B | Grade 5 AE | 2 Participants |
| Treatment Part A: Placebo | The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part B | Any Grade Drug-Related AE | 108 Participants |
| Treatment Part A: Placebo | The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part B | Grade 3-4 Drug-Related AE | 5 Participants |
| Treatment Part A: Placebo | The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part B | Grade 5 Drug-Related AE | 0 Participants |
| Treatment Part A: Placebo | The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part B | Any Grade AE | 182 Participants |
| Treatment Part A: Placebo | The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part B | Grade 3-4 AE | 32 Participants |
| Treatment Part B: Nivo + Ipi | The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part B | Any Grade AE | 367 Participants |
| Treatment Part B: Nivo + Ipi | The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part B | Grade 3-4 Drug-Related AE | 46 Participants |
| Treatment Part B: Nivo + Ipi | The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part B | Grade 5 AE | 2 Participants |
| Treatment Part B: Nivo + Ipi | The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part B | Grade 3-4 AE | 85 Participants |
| Treatment Part B: Nivo + Ipi | The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part B | Grade 5 Drug-Related AE | 0 Participants |
| Treatment Part B: Nivo + Ipi | The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part B | Any Grade Drug-Related AE | 300 Participants |
Secondary
The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part A
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Graded according to NCI CTCAE (Version 4) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death.
Time frame: From first dose to 30 days post last dose (up to approximately 40 weeks)
Population: All Treated Participants in Treatment Part A
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Part A: Nivo + Ipi | The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part A | Any Grade AE | 392 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part A | Grade 3-4 AE | 154 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part A | Grade 5 AE | 1 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part A | Any Grade Drug-Related AE | 359 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part A | Grade 3-4 Drug-Related AE | 114 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part A | Grade 5 Drug-Related AE | 0 Participants |
| Treatment Part A: Placebo | The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part A | Grade 3-4 Drug-Related AE | 8 Participants |
| Treatment Part A: Placebo | The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part A | Any Grade AE | 362 Participants |
| Treatment Part A: Placebo | The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part A | Any Grade Drug-Related AE | 230 Participants |
| Treatment Part A: Placebo | The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part A | Grade 3-4 AE | 44 Participants |
| Treatment Part A: Placebo | The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part A | Grade 5 Drug-Related AE | 0 Participants |
| Treatment Part A: Placebo | The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part A | Grade 5 AE | 0 Participants |
Secondary
The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part B
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Graded according to NCI CTCAE (Version 4) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death.
Time frame: From first dose to 30 days post last dose (up to approximately 40 weeks)
Population: All Treated Participants in Treatment Part B
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Part A: Nivo + Ipi | The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part B | Any Grade AE | 193 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part B | Grade 3-4 AE | 59 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part B | Grade 5 AE | 1 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part B | Any Grade Drug-Related AE | 173 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part B | Grade 3-4 Drug-Related AE | 41 Participants |
| Treatment Part A: Nivo + Ipi | The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part B | Grade 5 Drug-Related AE | 0 Participants |
| Treatment Part A: Placebo | The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part B | Grade 5 Drug-Related AE | 0 Participants |
| Treatment Part A: Placebo | The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part B | Any Grade AE | 182 Participants |
| Treatment Part A: Placebo | The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part B | Any Grade Drug-Related AE | 107 Participants |
| Treatment Part A: Placebo | The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part B | Grade 3-4 Drug-Related AE | 4 Participants |
| Treatment Part A: Placebo | The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part B | Grade 3-4 AE | 31 Participants |
| Treatment Part A: Placebo | The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part B | Grade 5 AE | 1 Participants |
| Treatment Part B: Nivo + Ipi | The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part B | Grade 3-4 AE | 70 Participants |
| Treatment Part B: Nivo + Ipi | The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part B | Grade 5 AE | 0 Participants |
| Treatment Part B: Nivo + Ipi | The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part B | Grade 5 Drug-Related AE | 0 Participants |
| Treatment Part B: Nivo + Ipi | The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part B | Any Grade Drug-Related AE | 297 Participants |
| Treatment Part B: Nivo + Ipi | The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part B | Any Grade AE | 362 Participants |
| Treatment Part B: Nivo + Ipi | The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part B | Grade 3-4 Drug-Related AE | 36 Participants |