Trial · NCT03138512
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
NCT03138512, Phase 3, Completed, Bristol-Myers Squibb; results first posted 2024-12-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT03138512. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03138512
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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
- NCT number
- NCT03138512
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,641 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Carcinoma, Renal Cell
- Interventions
- nivolumab, ipilimumab, nivolumab placebo, ipilimumab placebo
- First posted
- 2017-05-03
- Last updated
- 2024-12-18
- Other registries' IDs
- eudract:2016-004502-34
- Results first posted
- 2024-12-18
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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 |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| 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 | 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. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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) | 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. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) - Treatment Part A and B | From randomization to the date of death (up to approximately 72 months) | 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. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) Rate (5 Years) - Treatment Part A and B | At 5 years | All randomized participants in Treatment Part A (Nivo + Ipi and Placebo Arms). Data was not collected for Treatment Part B. | Percent of participants | NUMBER |
| SECONDARY | 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) | 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. | Months | MEDIAN |
| SECONDARY | 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) | 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. | Months | MEDIAN |
| SECONDARY | 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) | All Treated Participants in Treatment Part A | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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) | All Treated Participants in Treatment Part B | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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) | All Treated Participants in Treatment Part A | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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) | All Treated Participants in Treatment Part B | Participants | COUNT_OF_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 | From first dose to 30 days post last dose (up to approximately 40 weeks) | All treated participants in Treatment Part A with a CTC graded laboratory result for the given parameter from both baseline and on-treatment | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group274
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Disease-Free Survival (DFS) by BICR - Treatment Part A and B | Treatment Part A: Nivo + Ipi | NA | 95% Confidence Interval NA to NA | Months | |
| Disease-Free Survival (DFS) by BICR - Treatment Part A and B | Treatment Part A: Placebo | NA | 95% Confidence Interval 65.58 to NA | Months | |
| Disease-Free Survival (DFS) by BICR - Treatment Part A and B | Treatment Part B: Placebo | NA | 95% Confidence Interval NA to NA | Months | |
| Disease-Free Survival (DFS) by BICR - Treatment Part A and B | Treatment Part B: Nivo | NA | 95% Confidence Interval NA to NA | Months | |
| Overall Survival (OS) - Treatment Part A and B | Treatment Part A: Nivo + Ipi | NA | 95% Confidence Interval NA to NA | Months | |
| Overall Survival (OS) - Treatment Part A and B | Treatment Part A: Placebo | NA | 95% Confidence Interval NA to NA | Months | |
| Overall Survival (OS) - Treatment Part A and B | Treatment Part B: Placebo | NA | 95% Confidence Interval NA to NA | Months | |
| Overall Survival (OS) - Treatment Part A and B | Treatment Part B: Nivo | NA | 95% Confidence Interval NA to NA | Months | |
| Overall Survival (OS) Rate (5 Years) - Treatment Part A and B | Treatment Part A: Nivo + Ipi | 85.0 | 95% Confidence Interval 80.8 to 88.3 | Percent of participants | |
| Overall Survival (OS) Rate (5 Years) - Treatment Part A and B | Treatment Part A: Placebo | 87.2 | 95% Confidence Interval 82.8 to 90.5 | Percent of participants |
1 to 10 of 274Source ClinicalTrials.gov
See all 274 results by groupParticipant flow45
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Randomization | STARTED | Treatment Part A: Nivo + Ipi | 405 | |
| Randomization | STARTED | Treatment Part A: Placebo | 411 | |
| Randomization | STARTED | Treatment Part B: Nivo + Ipi | 206 | |
| Randomization | STARTED | Treatment Part B: Placebo | 208 | |
| Randomization | STARTED | Treatment Part B: Nivo | 411 | |
| Randomization | COMPLETED | Treatment Part A: Nivo + Ipi | 404 | |
| Randomization | COMPLETED | Treatment Part A: Placebo | 407 | |
| Randomization | COMPLETED | Treatment Part B: Nivo + Ipi | 204 | |
| Randomization | COMPLETED | Treatment Part B: Placebo | 207 | |
| Randomization | COMPLETED | Treatment Part B: Nivo | 408 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 participant flowAdverse events756
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Treatment Part A and B: Nivo + Ipi | 42 | 608 | |
| other | Anaemia | Blood and lymphatic system disorders | Treatment Part A and B: Placebo | 24 | 614 | |
| other | Anaemia | Blood and lymphatic system disorders | Treatment Part B: Nivo | 21 | 408 | |
| other | Adrenal insufficiency | Endocrine disorders | Treatment Part A and B: Nivo + Ipi | 52 | 608 | |
| other | Adrenal insufficiency | Endocrine disorders | Treatment Part A and B: Placebo | 4 | 614 | |
| other | Adrenal insufficiency | Endocrine disorders | Treatment Part B: Nivo | 13 | 408 | |
| other | Hyperthyroidism | Endocrine disorders | Treatment Part A and B: Nivo + Ipi | 98 | 608 | |
| other | Hyperthyroidism | Endocrine disorders | Treatment Part A and B: Placebo | 8 | 614 | |
| other | Hyperthyroidism | Endocrine disorders | Treatment Part B: Nivo | 47 | 408 | |
| other | Hypothyroidism | Endocrine disorders | Treatment Part A and B: Nivo + Ipi | 131 | 608 |
1 to 10 of 756Source ClinicalTrials.gov
See all 756 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment Part A and B: Nivo + Ipi | 65 | 611 |
| Total, all-cause mortality | Treatment Part A and B: Placebo | 55 | 619 |
| Total, all-cause mortality | Treatment Part B: Nivo | 22 | 411 |
| Total, other adverse events | Treatment Part A and B: Nivo + Ipi | 544 | 608 |
| Total, other adverse events | Treatment Part A and B: Placebo | 469 | 614 |
| Total, other adverse events | Treatment Part B: Nivo | 325 | 408 |
| Total, serious adverse events | Treatment Part A and B: Nivo + Ipi | 196 | 608 |
| Total, serious adverse events | Treatment Part A and B: Placebo | 49 | 614 |
| Total, serious adverse events | Treatment Part B: Nivo | 56 | 408 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03138512
GET https://conductscience.org/api/trials/v1/NCT03138512/results?page=2