A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

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

PFS is defined as the time from date of randomization to the first documented tumor progression date or death due to any cause, whichever occurs first based on BICR assessment using RECIST v1.1. Participants who die without a reported progression will be considered to have progressed on the date of their death. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment on or prior to initiation of subsequent anti-cancer therapy. Progressive disease (PD); 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study

All Randomized Participants of treatment A and treatment C

→

secondary · POSTED

Overall Survival is defined as the time between the date of randomization and the date of death due to any cause. For participants that are alive, their survival time will be censored at the date of last contact date (or "last known alive date").

All Randomized Participants of treatment A and treatment C

→

secondary · POSTED

Objective Response Rate (ORR) is defined as the percentage of randomized participants who achieve a best response of confirmed complete response (CR) or confirmed partial response (PR) based on BICR assessments (using RECIST v1.1 criteria) divided by the number of all randomized participants. Complete response (CR): Disappearance of all target lesions. Partial response (PR): 30% decrease in the sum of diameters of target lesions.

All Randomized Participants

→

secondary · POSTED

Number of participants experiencing various types of any grade adverse events (AEs) during the specified time frame.

All Treated Participants

→

secondary · POSTED

Number of participants experiencing various types of any grade serious adverse events (SAEs) during the specified time frame.

All Treated Participants

→

secondary · POSTED

Number of participants experiencing various types of any grade adverse events (AEs) leading to discontinuation during the specified time frame.

All Treated Participants

→

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-welireg-ac99f5fa
nct id: NCT03141177
trial label: A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma
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-welireg-ac99f5fa
nct id
NCT03141177
outcome key
om-0000
source section id
NCT03141177-om-0000
source outcome index
0
endpoint
Progression Free Survival (PFS)
endpoint definition
PFS is defined as the time from date of randomization to the first documented tumor progression date or death due to any cause, whichever occurs first based on BICR assessment using RECIST v1.1. Participants who die without a reported progression will be considered to have progressed on the date of their death. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment on or prior to initiation of subsequent anti-cancer therapy. Progressive disease (PD); 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study
time origin
From randomization date to date of first documented tumor progression or death, whichever occurs first (Up to 31 months)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All Randomized Participants of treatment A and treatment C
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-welireg-ac99f5fa
nct id
NCT03141177
outcome key
om-0001
source section id
NCT03141177-om-0001
source outcome index
1
endpoint
Overall Survival (OS)
endpoint definition
Overall Survival is defined as the time between the date of randomization and the date of death due to any cause. For participants that are alive, their survival time will be censored at the date of last contact date (or "last known alive date").
time origin
From randomization date to death date (Up to 31 months)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All Randomized Participants of treatment A and treatment C
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-welireg-ac99f5fa
nct id
NCT03141177
outcome key
om-0002
source section id
NCT03141177-om-0002
source outcome index
2
endpoint
Objective Response Rate (ORR)
endpoint definition
Objective Response Rate (ORR) is defined as the percentage of randomized participants who achieve a best response of confirmed complete response (CR) or confirmed partial response (PR) based on BICR assessments (using RECIST v1.1 criteria) divided by the number of all randomized participants. Complete response (CR): Disappearance of all target lesions. Partial response (PR): 30% decrease in the sum of diameters of target lesions.
time origin
Up to 31 Months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All Randomized 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-welireg-ac99f5fa
nct id
NCT03141177
outcome key
om-0003
source section id
NCT03141177-om-0003
source outcome index
3
endpoint
Number of Participants Experiencing Adverse Events (AEs)
endpoint definition
Number of participants experiencing various types of any grade adverse events (AEs) during the specified time frame.
time origin
From first dose to 100 days following last dose (Up to 32 Months)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All Treated 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-welireg-ac99f5fa
nct id
NCT03141177
outcome key
om-0004
source section id
NCT03141177-om-0004
source outcome index
4
endpoint
Number of Participants Experiencing Serious Adverse Events (SAEs)
endpoint definition
Number of participants experiencing various types of any grade serious adverse events (SAEs) during the specified time frame.
time origin
From first to dose to 100 days following last dose (Up to 32 months)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All Treated 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-welireg-ac99f5fa
nct id
NCT03141177
outcome key
om-0005
source section id
NCT03141177-om-0005
source outcome index
5
endpoint
Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
endpoint definition
Number of participants experiencing various types of any grade adverse events (AEs) leading to discontinuation during the specified time frame.
time origin
From first dose to 30 days following last dose (Up to 30 months)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All Treated Participants
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-welireg-ac99f5fa
nct id
NCT03141177
outcome key
om-0000
arm key
OG000
arm label
Treatment A
regimen
Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD
analyzed count
323
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03141177-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-welireg-ac99f5fa
nct id
NCT03141177
outcome key
om-0000
arm key
OG001
arm label
Treatment C
regimen
Sunitinib 50 mg PO QD for 4 weeks, followed by 2 weeks off, per cycle
analyzed count
328
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03141177-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-welireg-ac99f5fa
nct id
NCT03141177
outcome key
om-0001
arm key
OG000
arm label
Treatment A
regimen
Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD
analyzed count
323
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03141177-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-welireg-ac99f5fa
nct id
NCT03141177
outcome key
om-0001
arm key
OG001
arm label
Treatment C
regimen
Sunitinib 50 mg PO QD for 4 weeks, followed by 2 weeks off, per cycle
analyzed count
328
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03141177-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-welireg-ac99f5fa
nct id
NCT03141177
outcome key
om-0002
arm key
OG000
arm label
Treatment A
regimen
Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD
analyzed count
323
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03141177-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-welireg-ac99f5fa
nct id
NCT03141177
outcome key
om-0002
arm key
OG001
arm label
Treatment B
regimen
Nivolumab 3 mg/kg IV Q3W (x4 doses) + Cabozantinib 40 mg PO QD + Ipilimumab 1 mg/kg IV Q3W (x4 doses) Then Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD
analyzed count
50
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03141177-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-welireg-ac99f5fa
nct id
NCT03141177
outcome key
om-0002
arm key
OG002
arm label
Treatment C
regimen
Sunitinib 50 mg PO QD for 4 weeks, followed by 2 weeks off, per cycle
analyzed count
328
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03141177-om-0002#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-welireg-ac99f5fa
nct id
NCT03141177
outcome key
om-0003
arm key
OG000
arm label
Treatment A
regimen
Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD
analyzed count
320
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03141177-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-welireg-ac99f5fa
nct id
NCT03141177
outcome key
om-0003
arm key
OG001
arm label
Treatment B
regimen
Nivolumab 3 mg/kg IV Q3W (x4 doses) + Cabozantinib 40 mg PO QD + Ipilimumab 1 mg/kg IV Q3W (x4 doses) Then Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD
analyzed count
50
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03141177-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-welireg-ac99f5fa
nct id
NCT03141177
outcome key
om-0003
arm key
OG002
arm label
Treatment C
regimen
Sunitinib 50 mg PO QD for 4 weeks, followed by 2 weeks off, per cycle
analyzed count
320
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03141177-om-0003#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-welireg-ac99f5fa
nct id
NCT03141177
outcome key
om-0004
arm key
OG000
arm label
Treatment A
regimen
Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD
analyzed count
320
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03141177-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-welireg-ac99f5fa
nct id
NCT03141177
outcome key
om-0004
arm key
OG001
arm label
Treatment B
regimen
Nivolumab 3 mg/kg IV Q3W (x4 doses) + Cabozantinib 40 mg PO QD + Ipilimumab 1 mg/kg IV Q3W (x4 doses) Then Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD
analyzed count
50
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03141177-om-0004#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-welireg-ac99f5fa
nct id
NCT03141177
harm key
EG000
source section id
NCT03141177-ae
event group key
EG000
event group label
Treatment A
serious affected
160
serious at risk
320
other affected
316
other at risk
320
frequency threshold
5
collection period
All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
event definition
Source null
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-welireg-ac99f5fa
nct id
NCT03141177
harm key
EG001
source section id
NCT03141177-ae
event group key
EG001
event group label
Treatment B
serious affected
28
serious at risk
50
other affected
48
other at risk
50
frequency threshold
5
collection period
All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
event definition
Source null
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-welireg-ac99f5fa
nct id
NCT03141177
harm key
EG002
source section id
NCT03141177-ae
event group key
EG002
event group label
Treatment C
serious affected
144
serious at risk
320
other affected
306
other at risk
320
frequency threshold
5
collection period
All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
event definition
Source null
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