Trial · NCT03937219

Study of Cabozantinib in Combination With Nivolumab and Ipilimumab in Patients With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

NCT03937219, Phase 3, Active not recruiting, Exelixis; results first posted 2025-09-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of Cabozantinib in Combination With Nivolumab and Ipilimumab in Patients With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma. Trials, record NCT03937219. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03937219

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of Cabozantinib in Combination With Nivolumab and Ipilimumab in Patients With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma
NCT number: NCT03937219
Status: Active not recruiting
Phases: Phase 3
Enrollment: 855 participants, actual
Lead sponsor: Exelixis
Conditions: Renal Cell Carcinoma
Interventions: Cabozantinib, Nivolumab, Ipilimumab, Cabozantinib-matched placebo
First posted: 2019-05-03
Last updated: 2026-10-20
Results first posted: 2025-09-10

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Duration of Progression-Free Survival (PFS) by Blinded Independent Radiology Committee (BIRC)	Up to 32 months	Duration of PFS was defined as the time from randomization to the earlier of either the date of radiographic progression per BIRC or the date of death due to any cause. PFS (months) = (earliest date of progression, death, censoring - date of randomization + 1)/30.4375. PFS was determined as per Response Evaluation Criteria in Solid Tumors version (RECIST) v1.1.
Secondary	Duration of Overall Survival (OS)	Up to 58 months	Duration of OS (months) = (earliest date of death or censoring - date of randomization + 1)/30.4375.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Duration of Progression-Free Survival (PFS) by Blinded Independent Radiology Committee (BIRC)	Up to 32 months	PFS Intent-to-Treat (PITT) population was defined as the first 550 randomized participants regardless of whether any study treatment or the correct study treatment was received. Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.	months	MEDIAN
SECONDARY	Duration of Overall Survival (OS)	Up to 58 months	The ITT population was defined as all randomized participants regardless of whether any study treatment or the correct study treatment was received. Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.	months	MEDIAN

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Duration of Progression-Free Survival (PFS) by Blinded Independent Radiology Committee (BIRC)	Cabozantinib + Nivolumab + Ipilimumab	NA	95% Confidence Interval 14.00 to NA	months
Duration of Progression-Free Survival (PFS) by Blinded Independent Radiology Committee (BIRC)	Placebo + Nivolumab + Ipilimumab	11.30	95% Confidence Interval 7.69 to 18.17	months
Duration of Overall Survival (OS)	Cabozantinib + Nivolumab + Ipilimumab	41.86	95% Confidence Interval 34.79 to 47.87	months
Duration of Overall Survival (OS)	Placebo + Nivolumab + Ipilimumab	41.99	95% Confidence Interval 34.92 to 53.13	months

Source ClinicalTrials.gov

Participant flow14

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Cabozantinib + Nivolumab + Ipilimumab	428
Overall Study	STARTED	Placebo + Nivolumab + Ipilimumab	427
Overall Study	Received at Least 1 Dose of Study Drug	Cabozantinib + Nivolumab + Ipilimumab	426
Overall Study	Received at Least 1 Dose of Study Drug	Placebo + Nivolumab + Ipilimumab	423
Overall Study	Progression Free Survival (PFS) Intent-to-Treat (PITT) Population	Cabozantinib + Nivolumab + Ipilimumab	276
Overall Study	Progression Free Survival (PFS) Intent-to-Treat (PITT) Population	Placebo + Nivolumab + Ipilimumab	274
Overall Study	Safety Analysis Set	Cabozantinib + Nivolumab + Ipilimumab	426
Overall Study	Safety Analysis Set	Placebo + Nivolumab + Ipilimumab	423
Overall Study	Intent to Treat (ITT) Population	Cabozantinib + Nivolumab + Ipilimumab	428
Overall Study	Intent to Treat (ITT) Population	Placebo + Nivolumab + Ipilimumab	427

1 to 10 of 14Source ClinicalTrials.gov

See all 14 participant flow

Adverse events820

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
other	Anaemia	Blood and lymphatic system disorders	Cabozantinib + Nivolumab + Ipilimumab	77	426
other	Anaemia	Blood and lymphatic system disorders	Placebo + Nivolumab + Ipilimumab	94	423
other	Neutropenia	Blood and lymphatic system disorders	Cabozantinib + Nivolumab + Ipilimumab	29	426
other	Neutropenia	Blood and lymphatic system disorders	Placebo + Nivolumab + Ipilimumab	12	423
other	Thrombocytopenia	Blood and lymphatic system disorders	Cabozantinib + Nivolumab + Ipilimumab	23	426
other	Thrombocytopenia	Blood and lymphatic system disorders	Placebo + Nivolumab + Ipilimumab	6	423
other	Hypothyroidism	Endocrine disorders	Cabozantinib + Nivolumab + Ipilimumab	122	426
other	Hypothyroidism	Endocrine disorders	Placebo + Nivolumab + Ipilimumab	81	423
other	Hyperthyroidism	Endocrine disorders	Cabozantinib + Nivolumab + Ipilimumab	54	426
other	Hyperthyroidism	Endocrine disorders	Placebo + Nivolumab + Ipilimumab	48	423

1 to 10 of 820Source ClinicalTrials.gov

See all 820 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Cabozantinib + Nivolumab + Ipilimumab	224	426
Total, all-cause mortality	Placebo + Nivolumab + Ipilimumab	217	423
Total, other adverse events	Cabozantinib + Nivolumab + Ipilimumab	421	426
Total, other adverse events	Placebo + Nivolumab + Ipilimumab	416	423
Total, serious adverse events	Cabozantinib + Nivolumab + Ipilimumab	272	426
Total, serious adverse events	Placebo + Nivolumab + Ipilimumab	257	423

Source ClinicalTrials.gov

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
33058158	DERIVED	PubMed
34550754	DERIVED	PubMed
35383907	DERIVED	PubMed
37163623	DERIVED	PubMed

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
Cabozantinib + Nivolumab + Ipilimumab vs Placebo + Nivolumab + Ipilimumab: deaths from any cause	Trial comparisons
Cabozantinib + Nivolumab + Ipilimumab vs Placebo + Nivolumab + Ipilimumab: 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT03937219

GET https://conductscience.org/api/trials/v1/NCT03937219/events?page=2

API reference For AI assistants