Nivolumab Combined With Ipilimumab Versus Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (CheckMate 214)

Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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

All Intermediate/Poor-Risk Participants

→

primary · POSTED

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.

All Intermediate/Poor-Risk Participants

→

primary · POSTED

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.

All Intermediate/Poor-Risk Participants

→

secondary · POSTED

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

All Randomized

→

secondary · POSTED

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.

All Randomized

→

secondary · POSTED

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.

All Randomized

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-renal-cell-cancer-vegzelma-dfaad695
nct id: NCT02231749
trial label: Nivolumab Combined With Ipilimumab Versus Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (CheckMate 214)
applicability: unclear
applicability note: Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: regulator-cited
discovery note: Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count: 6
harms Count: 3
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-vegzelma-dfaad695
nct id
NCT02231749
outcome key
om-0000
source section id
NCT02231749-om-0000
source outcome index
0
endpoint
Objective Response Rate (ORR) in Intermediate/Poor Risk Participants Per Independent Radiology Review Committee (IRRC) Using RECIST v1.1
endpoint definition
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
time origin
From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assessed up to June 2017, approximately 31 months)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All Intermediate/Poor-Risk Participants
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-vegzelma-dfaad695
nct id
NCT02231749
outcome key
om-0001
source section id
NCT02231749-om-0001
source outcome index
1
endpoint
Overall Survival (OS) in Intermediate/Poor-Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)
endpoint definition
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.
time origin
From the date of randomization to the date of death (assessed up to June 2017, approximately 31 months)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All Intermediate/Poor-Risk Participants
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-vegzelma-dfaad695
nct id
NCT02231749
outcome key
om-0002
source section id
NCT02231749-om-0002
source outcome index
2
endpoint
Progression-Free Survival (PFS) in Intermediate/Poor-Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)
endpoint definition
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.
time origin
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)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All Intermediate/Poor-Risk Participants
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-vegzelma-dfaad695
nct id
NCT02231749
outcome key
om-0003
source section id
NCT02231749-om-0003
source outcome index
3
endpoint
Investigator-assessed Objective Response Rate(ORR) in Any Risk Participants Per IRRC Using RECIST v1.1
endpoint definition
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
time origin
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)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All Randomized
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-vegzelma-dfaad695
nct id
NCT02231749
outcome key
om-0004
source section id
NCT02231749-om-0004
source outcome index
4
endpoint
Overall Survival (OS) in Any Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)
endpoint definition
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.
time origin
From the date of randomization to the date of death (assessed up to approximately 125 months and 6 days)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All Randomized
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-vegzelma-dfaad695
nct id
NCT02231749
outcome key
om-0005
source section id
NCT02231749-om-0005
source outcome index
5
endpoint
Progression-Free Survival (PFS) in Any Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)
endpoint definition
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.
time origin
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)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All Randomized
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-vegzelma-dfaad695
nct id
NCT02231749
outcome key
om-0000
arm key
OG000
arm label
Nivolumab + Ipilimumab
regimen
Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
analyzed count
425
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02231749-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-vegzelma-dfaad695
nct id
NCT02231749
outcome key
om-0000
arm key
OG001
arm label
Sunitinib
regimen
Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks
analyzed count
422
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02231749-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-vegzelma-dfaad695
nct id
NCT02231749
outcome key
om-0001
arm key
OG000
arm label
Nivolumab + Ipilimumab
regimen
Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
analyzed count
425
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02231749-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-vegzelma-dfaad695
nct id
NCT02231749
outcome key
om-0001
arm key
OG001
arm label
Sunitinib
regimen
Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks
analyzed count
422
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02231749-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-vegzelma-dfaad695
nct id
NCT02231749
outcome key
om-0002
arm key
OG000
arm label
Nivolumab + Ipilimumab
regimen
Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
analyzed count
425
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02231749-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-vegzelma-dfaad695
nct id
NCT02231749
outcome key
om-0002
arm key
OG001
arm label
Sunitinib
regimen
Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks
analyzed count
422
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02231749-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-vegzelma-dfaad695
nct id
NCT02231749
outcome key
om-0003
arm key
OG000
arm label
Nivolumab + Ipilimumab
regimen
Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
analyzed count
550
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02231749-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-vegzelma-dfaad695
nct id
NCT02231749
outcome key
om-0003
arm key
OG001
arm label
Sunitinib
regimen
Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks
analyzed count
546
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02231749-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-vegzelma-dfaad695
nct id
NCT02231749
outcome key
om-0004
arm key
OG000
arm label
Nivolumab + Ipilimumab
regimen
Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
analyzed count
550
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02231749-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-vegzelma-dfaad695
nct id
NCT02231749
outcome key
om-0004
arm key
OG001
arm label
Sunitinib
regimen
Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks
analyzed count
546
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02231749-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-vegzelma-dfaad695
nct id
NCT02231749
outcome key
om-0005
arm key
OG000
arm label
Nivolumab + Ipilimumab
regimen
Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
analyzed count
550
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02231749-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-vegzelma-dfaad695
nct id
NCT02231749
outcome key
om-0005
arm key
OG001
arm label
Sunitinib
regimen
Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks
analyzed count
546
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02231749-om-0005#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-vegzelma-dfaad695
nct id
NCT02231749
harm key
EG000
source section id
NCT02231749-ae
event group key
EG000
event group label
Nivolumab + Ipilimumab
serious affected
367
serious at risk
547
other affected
534
other at risk
547
frequency threshold
5
collection period
Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
event definition
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-vegzelma-dfaad695
nct id
NCT02231749
harm key
EG001
source section id
NCT02231749-ae
event group key
EG001
event group label
Sunitinib
serious affected
277
serious at risk
535
other affected
523
other at risk
535
frequency threshold
5
collection period
Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
event definition
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-vegzelma-dfaad695
nct id
NCT02231749
harm key
EG002
source section id
NCT02231749-ae
event group key
EG002
event group label
Sunitinib Crossover
serious affected
6
serious at risk
25
other affected
25
other at risk
25
frequency threshold
5
collection period
Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
event definition
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice