A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma
NCT03141177 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 701
Last updated 2025-06-06
Summary
The purpose of this study is to determine whether Nivolumab Combined with Cabozantinib is safe and effective compared to Sunitinib in previously untreated advanced or metastatic renal cell carcinoma
Conditions
Interventions
- BIOLOGICAL
-
Specified dose on specified day
- DRUG
-
Specified dose on specified days
- DRUG
-
Sunitinib
Specified dose on specified days.
- BIOLOGICAL
-
Specified dose on specified days
Sponsors & Collaborators
- collaborator INDUSTRY
-
Ono Pharmaceutical Co. Ltd
collaborator INDUSTRY - lead INDUSTRY
Principal Investigators
-
Bristol-Myers Squibb · Bristol-Myers Squibb
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-07-23
- Primary Completion
- 2020-02-12
- Completion
- 2026-01-16
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Australia
- Brazil
- Chile
- Czechia
- Germany
- Greece
- Israel
- Italy
- Japan
- Mexico
- Poland
- Romania
- Russia
- Spain
- Turkey (Türkiye)
- United Kingdom
Study Locations
More Related Trials
-
A Phase II Study of Nivolumab With Ipilimumab and Cabozantinib in Patients With Untreated Renal Cell Carcinoma Brain Metastases
NCT05048212 ·Status: RECRUITING ·Phase: PHASE2
-
Study of XL092 + Nivolumab vs Sunitinib in Subjects With Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma
NCT05678673 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Study of the Effectiveness of Cabozantinib in Combination With Nivolumab as First-line Treatment of Advanced Renal Cell Carcinoma (aRCC) in Adults
NCT05361434 ·Status: ACTIVE_NOT_RECRUITING
-
A Study of Subcutaneous Nivolumab Versus Intravenous Nivolumab in Participants With Previously Treated Clear Cell Renal Cell Carcinoma That is Advanced or Has Spread
NCT04810078 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Retrospective Study on the Safety of Nivolumab in Patients With mRCC and Renal Failure
NCT07117409 ·Status: TERMINATED
-
Cabozantinib-s-malate or Sunitinib Malate in Treating Patients With Previously Untreated Locally Advanced or Metastatic Kidney Cancer
NCT01835158 ·Status: COMPLETED ·Phase: PHASE2
-
Nivolumab in Patients With Metastatic Renal Cell Carcinoma Who Have Progresses During or After Prior Systemic Anti-angiogenic Regimen
NCT03013335 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Front Line Therapy With Nivolumab and Salvage Nivolumab + Ipilimumab in Patients With Advanced Renal Cell Carcinoma
NCT03117309 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Nivolumab Combined With Ipilimumab Versus Nivolumab Alone in Participants With Advanced Kidney Cancer
NCT03873402 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Study of Nivolumab In Combination With Cabozantinib in Patients With Non-Clear Cell Renal Cell Carcinoma
NCT03635892 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Rapid Sequencing of Approved Therapies in Patients with Metastatic or Unresectable Clear Cell Renal Cell Carcinoma
NCT05188118 ·Status: RECRUITING ·Phase: EARLY_PHASE1
-
A Study of Nivolumab Plus Ipilimumab in Participants With Renal Cell Cancer in the Real World Setting in Japan
NCT04043975 ·Status: COMPLETED
-
Sunitinib Before and After Surgery in Treating Patients With Stage IV Kidney Cancer
NCT00717587 ·Status: UNKNOWN ·Phase: PHASE2
-
Safety and Effectiveness of Nivolumab in Recurring Kidney Cancer Participants
NCT03568435 ·Status: COMPLETED
-
Patient Preference Study of Pazopanib Versus Sunitinib in Advanced or Metastatic Kidney Cancer
NCT01064310 ·Status: COMPLETED ·Phase: PHASE3
-
Cabozantinib or Sunitinib Malate in Treating Participants With Metastatic Variant Histology Renal Cell Carcinoma
NCT03541902 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Phase 1b/2 Study of Combination 177Lu Girentuximab Plus Cabozantinib and Nivolumab in Treatment naïve Patients With Advanced Clear Cell RCC
NCT05663710 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
A Non-interventional Retrospective Study to Describe Early Clinical Experience With Cabozantinib in Patients With Advanced Renal Cell Carcinoma (RCC) in the UK
NCT03696407 ·Status: COMPLETED
-
Cabozantinib in the Elderly With Metastatic Renal Cell Carcinoma
NCT04416646 ·Status: COMPLETED
-
Nivolumab Plus Stereotactic Body Radiotherapy in II and III Line of Patients With Metastatic Renal Cell Carcinoma
NCT03469713 ·Status: COMPLETED ·Phase: PHASE2
-
CaboCHECK - Cabozantinib in Adult Patients With Advanced Renal Cell Carcinoma Following Prior Systemic Check Point Inhibition Therapy: a Retrospective, Non-interventional Study
NCT04147143 ·Status: TERMINATED
-
Study of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma
NCT07011719 ·Status: RECRUITING ·Phase: PHASE3
-
Sunitinib Malate With or Without Gemcitabine Hydrochloride in Treating Patients With Advanced Kidney Cancer That Cannot Be Removed By Surgery
NCT01164228 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Evaluate the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Axitinib Versus Sunitinib Monotherapy in Participants With Renal Cell Carcinoma (MK-3475-426/KEYNOTE-426)
NCT02853331 ·Status: COMPLETED ·Phase: PHASE3
-
A Subject Treatment Preference Study of Tivozanib Versus Sunitinib in Subjects With Metastatic RCC
NCT01673386 ·Status: TERMINATED ·Phase: PHASE2