Trial · NCT02231749
Nivolumab Combined With Ipilimumab Versus Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (CheckMate 214)
NCT02231749, Phase 3, Completed, Bristol-Myers Squibb; results first posted 2018-10-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Nivolumab Combined With Ipilimumab Versus Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (CheckMate 214). Trials, record NCT02231749. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02231749
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nivolumab Combined With Ipilimumab Versus Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (CheckMate 214)
- NCT number
- NCT02231749
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,096 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Advanced Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma
- Interventions
- Nivolumab, Ipilimumab, Sunitinib
- First posted
- 2014-09-04
- Last updated
- 2026-05-27
- Other registries' IDs
- eudract:2014-001750-42
- Results first posted
- 2018-10-16
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) in Intermediate/Poor Risk Participants Per Independent Radiology Review Committee (IRRC) Using RECIST v1.1 | From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assessed up to June 2017, approximately 31 months) | ORR was defined as the proportion of randomized subjects who achieved a best response of complete response (CR) or partial response (PR) using the RECIST v1.1 criteria based on Independent Radiology Review Committee (IRRC) assessment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), greater than or equal to 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR |
| Primary | Overall Survival (OS) in Intermediate/Poor-Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC) | From the date of randomization to the date of death (assessed up to June 2017, approximately 31 months) | OS was defined as the time from randomization to the date of death from any cause. Survival time was censored at the date of last contact ("last known alive date") for subjects who were alive. |
| Primary | Progression-Free Survival (PFS) in Intermediate/Poor-Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC) | From date of first dose to date of documented disease progression or death due to any cause, whichever occurs first (assessed up to June 2017, approximately 31 months) | PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the IRRC (as per RECIST 1.1 criteria), or death due to any cause, whichever occurred first. Subsequent therapy included anticancer therapy, tumor directed radiotherapy, or tumor directed surgery. Subjects who died without a reported progression were considered to have progressed on the date of their death. |
| Secondary | Investigator-assessed Objective Response Rate(ORR) in Any Risk Participants Per IRRC Using RECIST v1.1 | From the date of randomization until date of documented disease progression or subsequent therapy, whichever occurs first (assessed up to approximately 125 months and 6 days) | ORR was defined as the proportion of randomized subjects who achieved a best response of complete response (CR) or partial response (PR) using the RECIST v1.1 criteria based on IRRC assessment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), greater than or equal to 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR |
| Secondary | Overall Survival (OS) in Any Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC) | From the date of randomization to the date of death (assessed up to approximately 125 months and 6 days) | Overall survival is defined as the time from randomization to the date of death from any cause. For subjects that are alive, their survival time will be censored at the date of last contact ("last known alive date"). Overall survival will be censored for subjects at the date of randomization if they were randomized but had no follow-up. Survival follow-up will be conducted every 3 months after subject's off-treatment date. |
| Secondary | Progression-Free Survival (PFS) in Any Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC) | From the date of randomization to date of documented disease progression or death due to any cause, whichever occurs first (assessed up to approximately 125 months and 6 days) | PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the IRRC (as per RECIST 1.1 criteria), or death due to any cause, whichever occurred first. Subsequent therapy included anticancer therapy, tumor directed radiotherapy, or tumor directed surgery. Subjects who died without a reported progression were considered to have progressed on the date of their death. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Investigator-assessed Objective Response Rate(ORR) in Intermediate/Poor Risk Participants Per IRRC Using RECIST v1.1 | From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assessed up to June 2017, approximately 31 months) | All Intermediate/Poor-Risk Participants | percentage of participants | NUMBER |
| PRIMARY | Overall Survival (OS) in Intermediate/Poor-Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC) | From the date of randomization to the date of death (assessed up to June 2017, approximately 31 months) | All Intermediate/Poor-Risk Participants | months | MEDIAN |
| PRIMARY | Progression-Free Survival (PFS) in Intermediate/Poor-Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC) | From date of first dose to date of documented disease progression or death due to any cause, whichever occurs first (assessed up to June 2017, approximately 31 months) | All Intermediate/Poor-Risk Participants | months | MEDIAN |
| SECONDARY | Investigator-assessed Objective Response Rate(ORR) in Any Risk Participants Per IRRC Using RECIST v1.1 | From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assessed up to June 2017, approximately 31 months) | All Randomized | percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) in Any Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC) | From the date of randomization to the date of death (assessed up to June 2017, approximately 31 months) | All Randomized | months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) in Any Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC) | From date of first dose to date of documented disease progression or death due to any cause, whichever occurs first (assessed up to June 2017, approximately 31 months) | All Randomized | months | MEDIAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Investigator-assessed Objective Response Rate(ORR) in Intermediate/Poor Risk Participants Per IRRC Using RECIST v1.1 | Nivolumab + Ipilimumab | 41.6 | 95% Confidence Interval 36.9 to 46.5 | percentage of participants | |
| Investigator-assessed Objective Response Rate(ORR) in Intermediate/Poor Risk Participants Per IRRC Using RECIST v1.1 | Sunitinib | 26.5 | 95% Confidence Interval 22.4 to 31.0 | percentage of participants | |
| Overall Survival (OS) in Intermediate/Poor-Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC) | Nivolumab + Ipilimumab | NA | 95% Confidence Interval 28.16 to NA | months | |
| Overall Survival (OS) in Intermediate/Poor-Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC) | Sunitinib | 25.95 | 95% Confidence Interval 22.08 to NA | months | |
| Progression-Free Survival (PFS) in Intermediate/Poor-Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC) | Nivolumab + Ipilimumab | 11.56 | 95% Confidence Interval 8.71 to 15.51 | months | |
| Progression-Free Survival (PFS) in Intermediate/Poor-Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC) | Sunitinib | 8.38 | 95% Confidence Interval 7.03 to 10.81 | months | |
| Investigator-assessed Objective Response Rate(ORR) in Any Risk Participants Per IRRC Using RECIST v1.1 | Nivolumab + Ipilimumab | 38.7 | 95% Confidence Interval 34.6 to 42.9 | percentage of participants | |
| Investigator-assessed Objective Response Rate(ORR) in Any Risk Participants Per IRRC Using RECIST v1.1 | Sunitinib | 32.2 | 95% Confidence Interval 28.3 to 36.3 | percentage of participants | |
| Overall Survival (OS) in Any Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC) | Nivolumab + Ipilimumab | NA | 95% Confidence Interval NA to NA | months | |
| Overall Survival (OS) in Any Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC) | Sunitinib | 32.92 | 95% Confidence Interval NA to NA | months |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nivolumab + Ipilimumab | 550 | |
| Overall Study | STARTED | Sunitinib | 546 | |
| Overall Study | Received Treatment | Nivolumab + Ipilimumab | 547 | |
| Overall Study | Received Treatment | Sunitinib | 535 | |
| Overall Study | COMPLETED | Nivolumab + Ipilimumab | 128 | |
| Overall Study | COMPLETED | Sunitinib | 97 | |
| Overall Study | NOT COMPLETED | Nivolumab + Ipilimumab | 422 | |
| Overall Study | NOT COMPLETED | Sunitinib | 449 |
Source ClinicalTrials.gov
Adverse events786
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 | Nivolumab + Ipilimumab | 71 | 547 | |
| other | Anaemia | Blood and lymphatic system disorders | Sunitinib | 108 | 535 | |
| other | Leukopenia | Blood and lymphatic system disorders | Nivolumab + Ipilimumab | 1 | 547 | |
| other | Leukopenia | Blood and lymphatic system disorders | Sunitinib | 31 | 535 | |
| other | Neutropenia | Blood and lymphatic system disorders | Nivolumab + Ipilimumab | 3 | 547 | |
| other | Neutropenia | Blood and lymphatic system disorders | Sunitinib | 73 | 535 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Nivolumab + Ipilimumab | 6 | 547 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Sunitinib | 98 | 535 | |
| other | Hyperthyroidism | Endocrine disorders | Nivolumab + Ipilimumab | 63 | 547 | |
| other | Hyperthyroidism | Endocrine disorders | Sunitinib | 16 | 535 |
1 to 10 of 786Source ClinicalTrials.gov
See all 786 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nivolumab + Ipilimumab | 159 | 547 |
| Total, all-cause mortality | Sunitinib | 202 | 535 |
| Total, other adverse events | Nivolumab + Ipilimumab | 530 | 547 |
| Total, other adverse events | Sunitinib | 522 | 535 |
| Total, serious adverse events | Nivolumab + Ipilimumab | 305 | 547 |
| Total, serious adverse events | Sunitinib | 213 | 535 |
Source ClinicalTrials.gov
Papers14
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Nivolumab + Ipilimumab vs Sunitinib: deaths from any cause | Trial comparisons |
| Nivolumab + Ipilimumab vs Sunitinib: serious adverse events | Trial comparisons |
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/NCT02231749
GET https://conductscience.org/api/trials/v1/NCT02231749/events?page=2