18 and older, any sex, with Renal Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Duration of Progression-Free Survival (PFS) by Blinded Independent Radiology Committee (BIRC)Primary· 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.
Group
Value
95% CI
Cabozantinib + Nivolumab + Ipilimumab
NA
14.00 – NA
Placebo + Nivolumab + Ipilimumab
11.30
7.69 – 18.17
Duration of Overall Survival (OS)Secondary· Up to 58 months
Duration of OS (months) = (earliest date of death or censoring - date of randomization + 1)/30.4375.
Group
Value
95% CI
Cabozantinib + Nivolumab + Ipilimumab
41.86
34.79 – 47.87
Placebo + Nivolumab + Ipilimumab
41.99
34.92 – 53.13
Adverse events — posted to ClinicalTrials.gov
Time frame: Day 1 up to 58 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Cabozantinib + Nivolumab + Ipilimumab
Serious: 272/426 (64%)
Deaths: 224/426
Placebo + Nivolumab + Ipilimumab
Serious: 257/423 (61%)
Deaths: 217/423
Serious adverse events (347 terms)
Reaction
System
Cabozantinib + Nivolumab +…
Placebo + Nivolumab + Ipil…
Alanine aminotransferase increased
Investigations
—
—
Aspartate aminotransferase increased
Investigations
—
—
Immune-mediated hepatitis
Hepatobiliary disorders
—
—
Diarrhoea
Gastrointestinal disorders
—
—
COVID-19
Infections and infestations
—
—
Renal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Pneumonia
Infections and infestations
—
—
Adrenal insufficiency
Endocrine disorders
—
—
Colitis
Gastrointestinal disorders
—
—
Vomiting
Gastrointestinal disorders
—
—
Pyrexia
General disorders
—
—
Dyspnoea
Respiratory, thoracic and mediastinal disorders
—
—
Hyponatraemia
Metabolism and nutrition disorders
—
—
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
This is a multicenter, randomized, double-blinded, controlled Phase 3 trial of cabozantinib in combination with nivolumab and ipilimumab versus nivolumab and ipilimumab in combination with matched placebo. Approximately 840 eligible subjects with intermediate- or poor-risk advanced or metastatic RCC by IMDC criteria will be randomized in a 1:1 ratio at approximately 180 sites.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07383441 — Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer
· Phase 3
· not yet recruiting
NCT07293351 — A Study to Evaluate the Safety, Tolerability, and Efficacy of Pumitamig Alone or in Combination With Ipilimumab or Caboz
· Phase 1, PHASE2
· recruiting
NCT07187869 — Modulation of the Bone Immune Microenvironment Following Cabozantinib Treatment of Bone Metastatic Clear Cell Renal Cell
· Phase 1
· not yet recruiting
NCT07405164 — Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043)
· Phase 3
· recruiting
NCT06900595 — Testing the Addition of an Anti-Cancer Drug, Cabozantinib to the Immunotherapy Drug Cemiplimab (REGN2810), in Adolescent
· Phase 2
· recruiting
NCT07195682 — A First-in-Human Study of BMS-986506 in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)
· Phase 1
· recruiting
NCT07285044 — The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Tr
· Phase 2
· recruiting
NCT07227402 — A Clinical Study of Belzutifan and Zanzalintinib in People With Recurrent Kidney Cancer Following Adjuvant Therapy (MK-6
· Phase 3
· recruiting
NCT07123090 — A Study of Sasanlimab, Palbociclib and Axitinib in Metastatic Renal Cell Carcinoma
· Phase 2
· recruiting
Other Exelixis trials
Trials by the same sponsor.
NCT06630247 — A Dose-escalation, Dose-finding, and Expansion Study of XL495 in Participants With Locally Advanced or Metastatic Solid
· Phase 1
· terminated
NCT06545331 — Study of XB010 in Subjects With Solid Tumors
· Phase 1
· recruiting
NCT05932862 — A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
· Phase 1
· recruiting
NCT06191796 — Study of Zanzalintinib (XL092) + AB521 and Zanzalintinib + AB521 + Nivolumab in Participants With Advanced Clear Cell Re
· Phase 1
· terminated
NCT05144347 — Study of XL114 in Subjects With Non-Hodgkin's Lymphoma
· Phase 1
· terminated
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Exelixis
Last refreshed: 10 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03937219.