A Study Comparing Nivolumab, Nivolumab in Combination With Ipilimumab and Placebo in Participants With Localized Kidney Cancer Who Underwent Surgery to Remove Part of a Kidney
CompletedPhase 3Results postedLast updated 18 December 2024
What this trial tests
Phase 3 trial testing nivolumab in Carcinoma, Renal Cell in 1,641 participants. Completed in 1 February 2024.
18 and older, any sex, with Carcinoma, Renal Cell. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Disease-Free Survival (DFS) by BICR - Treatment Part A and BPrimary· 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.
Group
Value
95% CI
Treatment Part A: Nivo + Ipi
NA
NA – NA
Treatment Part A: Placebo
NA
65.58 – NA
Treatment Part B: Placebo
NA
NA – NA
Treatment Part B: Nivo
NA
NA – NA
Overall Survival (OS) - Treatment Part A and BSecondary· 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.
Group
Value
95% CI
Treatment Part A: Nivo + Ipi
NA
NA – NA
Treatment Part A: Placebo
NA
NA – NA
Treatment Part B: Placebo
NA
NA – NA
Treatment Part B: Nivo
NA
NA – NA
Overall Survival (OS) Rate (5 Years) - Treatment Part A and BSecondary· At 5 years
Overall survival rate at 5 years is defined as the percentage of participants who are alive at 5 years.
Group
Value
95% CI
Treatment Part A: Nivo + Ipi
85.0
80.8 – 88.3
Treatment Part A: Placebo
87.2
82.8 – 90.5
Disease-Free Survival (DFS) Per BICR in Contemporaneously Randomized Combination and Monotherapy Participants - Treatment Part BSecondary· 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.
Group
Value
95% CI
Treatment Part B: Nivo + Ipi
NA
36.17 – NA
Treatment Part B: Nivo
NA
NA – NA
Overall Survival (OS) in the Contemporaneously Randomized Combination and Monotherapy Participants - Treatment Part BSecondary· 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
Group
Value
95% CI
Treatment Part B: Nivo + Ipi
NA
NA – NA
Treatment Part B: Nivo
NA
NA – NA
The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part ASecondary· 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.
Any Grade AE
Group
Value
95% CI
Treatment Part A: Nivo + Ipi
392
Treatment Part A: Placebo
362
Grade 3-4 AE
Group
Value
95% CI
Treatment Part A: Nivo + Ipi
154
Treatment Part A: Placebo
44
Grade 5 AE
Group
Value
95% CI
Treatment Part A: Nivo + Ipi
1
Treatment Part A: Placebo
0
Any Grade Drug-Related AE
Group
Value
95% CI
Treatment Part A: Nivo + Ipi
359
Treatment Part A: Placebo
230
Grade 3-4 Drug-Related AE
Group
Value
95% CI
Treatment Part A: Nivo + Ipi
114
Treatment Part A: Placebo
8
Grade 5 Drug-Related AE
Group
Value
95% CI
Treatment Part A: Nivo + Ipi
0
Treatment Part A: Placebo
0
The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part BSecondary· 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.
Any Grade AE
Group
Value
95% CI
Treatment Part B: Nivo + Ipi
193
Treatment Part B: Placebo
182
Treatment Part B: Nivo
362
Grade 3-4 AE
Group
Value
95% CI
Treatment Part B: Nivo + Ipi
59
Treatment Part B: Placebo
31
Treatment Part B: Nivo
70
Grade 5 AE
Group
Value
95% CI
Treatment Part B: Nivo + Ipi
1
Treatment Part B: Placebo
1
Treatment Part B: Nivo
0
Any Grade Drug-Related AE
Group
Value
95% CI
Treatment Part B: Nivo + Ipi
173
Treatment Part B: Placebo
107
Treatment Part B: Nivo
297
Grade 3-4 Drug-Related AE
Group
Value
95% CI
Treatment Part B: Nivo + Ipi
41
Treatment Part B: Placebo
4
Treatment Part B: Nivo
36
Grade 5 Drug-Related AE
Group
Value
95% CI
Treatment Part B: Nivo + Ipi
0
Treatment Part B: Placebo
0
Treatment Part B: Nivo
0
The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part ASecondary· 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.
Any Grade AE
Group
Value
95% CI
Treatment Part A: Nivo + Ipi
393
Treatment Part A: Placebo
365
Grade 3-4 AE
Group
Value
95% CI
Treatment Part A: Nivo + Ipi
167
Treatment Part A: Placebo
52
Grade 5 AE
Group
Value
95% CI
Treatment Part A: Nivo + Ipi
4
Treatment Part A: Placebo
1
Any Grade Drug-Related AE
Group
Value
95% CI
Treatment Part A: Nivo + Ipi
361
Treatment Part A: Placebo
230
Grade 3-4 Drug-Related AE
Group
Value
95% CI
Treatment Part A: Nivo + Ipi
128
Treatment Part A: Placebo
9
Grade 5 Drug-Related AE
Group
Value
95% CI
Treatment Part A: Nivo + Ipi
2
Treatment Part A: Placebo
0
The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part BSecondary· 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.
Any Grade AE
Group
Value
95% CI
Treatment Part B: Nivo + Ipi
196
Treatment Part B: Placebo
182
Treatment Part B: Nivo
367
Grade 3-4 AE
Group
Value
95% CI
Treatment Part B: Nivo + Ipi
68
Treatment Part B: Placebo
32
Treatment Part B: Nivo
85
Grade 5 AE
Group
Value
95% CI
Treatment Part B: Nivo + Ipi
5
Treatment Part B: Placebo
2
Treatment Part B: Nivo
2
Any Grade Drug-Related AE
Group
Value
95% CI
Treatment Part B: Nivo + Ipi
175
Treatment Part B: Placebo
108
Treatment Part B: Nivo
300
Grade 3-4 Drug-Related AE
Group
Value
95% CI
Treatment Part B: Nivo + Ipi
46
Treatment Part B: Placebo
5
Treatment Part B: Nivo
46
Grade 5 Drug-Related AE
Group
Value
95% CI
Treatment Part B: Nivo + Ipi
0
Treatment Part B: Placebo
0
Treatment Part B: Nivo
0
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part ASecondary· 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.
HEMOGLOBIN
Group
Value
95% CI
Treatment Part A: Nivo + Ipi
1
Treatment Part A: Placebo
1
PLATELET COUNT
Group
Value
95% CI
Treatment Part A: Nivo + Ipi
1
Treatment Part A: Placebo
0
LEUKOCYTES, LOCAL LAB
Group
Value
95% CI
Treatment Part A: Nivo + Ipi
0
Treatment Part A: Placebo
0
LYMPHOCYTES (ABSOLUTE), TOTAL
Group
Value
95% CI
Treatment Part A: Nivo + Ipi
6
Treatment Part A: Placebo
3
ABSOLUTE NEUTROPHIL COUNT
Group
Value
95% CI
Treatment Part A: Nivo + Ipi
2
Treatment Part A: Placebo
0
ALKALINE PHOSPHATASE, LOCAL LAB
Group
Value
95% CI
Treatment Part A: Nivo + Ipi
3
Treatment Part A: Placebo
0
ASPARTATE AMINOTRANSFERASE, LOCAL LAB
Group
Value
95% CI
Treatment Part A: Nivo + Ipi
14
Treatment Part A: Placebo
3
ALANINE AMINOTRANSFERASE, LOCAL LAB
Group
Value
95% CI
Treatment Part A: Nivo + Ipi
16
Treatment Part A: Placebo
5
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part BSecondary· 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.
HEMOGLOBIN
Group
Value
95% CI
Treatment Part B: Nivo + Ipi
0
Treatment Part B: Placebo
3
Treatment Part B: Nivo
0
PLATELET COUNT
Group
Value
95% CI
Treatment Part B: Nivo + Ipi
0
Treatment Part B: Placebo
1
Treatment Part B: Nivo
0
LEUKOCYTES, LOCAL LAB
Group
Value
95% CI
Treatment Part B: Nivo + Ipi
0
Treatment Part B: Placebo
0
Treatment Part B: Nivo
1
LYMPHOCYTES (ABSOLUTE), TOTAL
Group
Value
95% CI
Treatment Part B: Nivo + Ipi
3
Treatment Part B: Placebo
1
Treatment Part B: Nivo
4
ABSOLUTE NEUTROPHIL COUNT
Group
Value
95% CI
Treatment Part B: Nivo + Ipi
0
Treatment Part B: Placebo
0
Treatment Part B: Nivo
1
ALKALINE PHOSPHATASE, LOCAL LAB
Group
Value
95% CI
Treatment Part B: Nivo + Ipi
1
Treatment Part B: Placebo
1
Treatment Part B: Nivo
0
ASPARTATE AMINOTRANSFERASE, LOCAL LAB
Group
Value
95% CI
Treatment Part B: Nivo + Ipi
4
Treatment Part B: Placebo
4
Treatment Part B: Nivo
5
ALANINE AMINOTRANSFERASE, LOCAL LAB
Group
Value
95% CI
Treatment Part B: Nivo + Ipi
7
Treatment Part B: Placebo
3
Treatment Part B: Nivo
8
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part ASecondary· 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.
HEMOGLOBIN
Group
Value
95% CI
Treatment Part A: Nivo + Ipi
1
Treatment Part A: Placebo
1
PLATELET COUNT
Group
Value
95% CI
Treatment Part A: Nivo + Ipi
1
Treatment Part A: Placebo
0
LEUKOCYTES, LOCAL LAB
Group
Value
95% CI
Treatment Part A: Nivo + Ipi
0
Treatment Part A: Placebo
0
LYMPHOCYTES (ABSOLUTE), TOTAL
Group
Value
95% CI
Treatment Part A: Nivo + Ipi
11
Treatment Part A: Placebo
3
ABSOLUTE NEUTROPHIL COUNT
Group
Value
95% CI
Treatment Part A: Nivo + Ipi
2
Treatment Part A: Placebo
0
ALKALINE PHOSPHATASE, LOCAL LAB
Group
Value
95% CI
Treatment Part A: Nivo + Ipi
5
Treatment Part A: Placebo
0
ASPARTATE AMINOTRANSFERASE, LOCAL LAB
Group
Value
95% CI
Treatment Part A: Nivo + Ipi
17
Treatment Part A: Placebo
3
ALANINE AMINOTRANSFERASE, LOCAL LAB
Group
Value
95% CI
Treatment Part A: Nivo + Ipi
20
Treatment Part A: Placebo
6
Adverse events — posted to ClinicalTrials.gov
Time frame: All-cause mortality was assessed from a participants first dose to their study completion (up to approximately 72 months) SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 50 weeks)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Treatment Part A and B: Nivo + Ipi
Serious: 196/608 (32%)
Deaths: 65/611
Treatment Part A and B: Placebo
Serious: 49/614 (8%)
Deaths: 55/619
Treatment Part B: Nivo
Serious: 56/408 (14%)
Deaths: 22/411
Serious adverse events (219 terms)
Reaction
System
Treatment Part A and B: Ni…
Treatment Part A and B: Pl…
Treatment Part B: Nivo
Adrenal insufficiency
Endocrine disorders
—
—
—
Diarrhoea
Gastrointestinal disorders
—
—
—
Acute kidney injury
Renal and urinary disorders
—
—
—
Hypophysitis
Endocrine disorders
—
—
—
Colitis
Gastrointestinal disorders
—
—
—
Pneumonitis
Respiratory, thoracic and mediastinal disorders
—
—
—
Immune-mediated enterocolitis
Gastrointestinal disorders
—
—
—
Pneumonia
Infections and infestations
—
—
—
Hyponatraemia
Metabolism and nutrition disorders
—
—
—
Vomiting
Gastrointestinal disorders
—
—
—
Hyperglycaemia
Metabolism and nutrition disorders
—
—
—
Hypopituitarism
Endocrine disorders
—
—
—
Abdominal pain
Gastrointestinal disorders
—
—
—
Pyrexia
General disorders
—
—
—
Urinary tract infection
Infections and infestations
—
—
—
Type 1 diabetes mellitus
Metabolism and nutrition disorders
—
—
—
Myocarditis
Cardiac disorders
—
—
—
Pancreatitis
Gastrointestinal disorders
—
—
—
Alanine aminotransferase increased
Investigations
—
—
—
Diabetes mellitus
Metabolism and nutrition disorders
—
—
—
Diabetic ketoacidosis
Metabolism and nutrition disorders
—
—
—
Recurrent cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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NCT07223424 — Patient Preference for Subcutaneous vs. Intravenous Immune Therapy
· Phase 2
· recruiting
NCT06410534 — A Phase II Study Evaluating an Organ Preservation Strategy Using Immune Checkpoint Blockade for Participants With Primar
· Phase 2
· withdrawn
NCT06421311 — Observational Study of Muscle Invasive Urothelial Carcinoma Participants Treated With Adjuvant Nivolumab in France
· terminated
NCT05743270 — Study of RP3 in Combination With Nivolumab and Other Therapy in Patients With Locoregionally Advanced or Recurrent SCCHN
· Phase 2
· withdrawn
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NCT06676527 — Vorolanib in the Second-line Treatment of Patients With Unresectable or Metastatic Renal Cell Carcinoma
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Other Bristol-Myers Squibb trials
Trials by the same sponsor.
NCT07441408 — Long-term Extension Study to Evaluate Safety and Tolerability of Admilparant in Participants With Pulmonary Fibrosis
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NCT07459543 — A Study To Assess the Safety, and Tolerability of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) In Untreated, Unre
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NCT07285798 — A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism Spectrum Disorder
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NCT07284745 — A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism
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NCT07492680 — A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic S
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bristol-Myers Squibb
Last refreshed: 18 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03138512.