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NCT Number: NCT03873402

A Study of Nivolumab Combined With Ipilimumab Versus Nivolumab Alone in Participants With Advanced Kidney Cancer

The purpose of this study is to test the effectiveness and safety of nivolumab combined with ipilimumab compared to nivolumab monotherapy in participants with previously untreated kidney cancer that has spread.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Renal Cell Carcinoma Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Local Institution - 0100, Capital Federal, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion criteria

  • Histological confirmation of renal carcinoma with clear cell component including participants who may have sarcomatoid features.
  • Advanced (not amenable to curative surgery or radiation therapy) renal cell carcinoma (RCC) or metastatic RCC (mRCC).
  • Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) criteria.
  • No prior systemic therapy for RCC
  • Must be intermediate or poor risk as per International Metastatic RCC Database Consortium (IMDC).

Exclusion criteria

  • Any active central nervous system (CNS) metastases.
  • Active, known, or suspected autoimmune disease.
  • Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibody, or any other agents specifically targeting T-cell co-stimulation or checkpoint pathways

Other protocol-defined inclusion/exclusion criteria apply

Treatment and study plan

Nivolumab

Biological

Specified dose on specified days

Other names: Opdivo

Ipilimumab

Biological

Specified dose on specified days

Other names: Yervoy

Ipilimumab placebo

Other

Specified dose on specified days

Primary outcomes

  1. Progression free survival (PFS) by blinded independent central review (BICR)

    Time frame: Up to 34 months

  2. Objective response rate (ORR) by BICR

    Time frame: Up to 23 months

Secondary outcomes

  1. Overall survival (OS)

    Time frame: Up to 4 years

  2. Overall response rate (ORR) by investigator

    Time frame: Up to 4 years

  3. Disease control rate (DCR) by investigator

    Time frame: Up to 4 years

  4. Duration of response (DoR) by investigator

    Time frame: Up to 4 years

  5. Time to objective response (TTR) by investigator

    Time frame: Up to 4 years

  6. Progression Free Survival (PFS) by investigator

    Time frame: Up to 4 years

  7. Progression free survival secondary objective (PFS2) by investigator

    Time frame: Up to 4 years

  8. Disease control rate (DCR) by BICR

    Time frame: Up to 4 years

  9. Duration of response (DoR) by BICR

    Time frame: Up to 4 years

  10. Time to objective response (TTR) by BICR

    Time frame: Up to 4 years

  11. Incidence of Adverse Events (AEs)

    Time frame: Up to 4 years

  12. Incidence of drug-related AEs

    Time frame: Up to 4 years

  13. Incidence of Severe Adverse Events (SAEs)

    Time frame: Up to 4 years

  14. Incidence of drug-related SAEs

    Time frame: Up to 4 years

  15. Incidence of clinically significant changes in clinical laboratory results: Hematology tests

    Time frame: Up to 4 years

  16. Incidence of clinically significant changes in clinical laboratory results: Coagulation tests

    Time frame: Up to 4 years

  17. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests

    Time frame: Up to 4 years

  18. Incidence of clinically significant changes in clinical laboratory results: Serology tests

    Time frame: Up to 4 years

  19. PFS based on gene expression (GEP) signatures

    Time frame: Up to 4 years

  20. Objective response rate (ORR) based on GEP signatures

    Time frame: Up to 4 years

  21. OS based on GEP signatures

    Time frame: Up to 4 years

  22. OS based on programmed cell death protein ligand-1 (PD-L1) expression

    Time frame: Up to 4 years

  23. ORR by BICR based on PD-L1 expression

    Time frame: Up to 4 years

  24. PFS by BICR based on PD-L1 expression

    Time frame: Up to 4 years

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 3b, Randomized, Double-blind Study of Nivolumab Combined With Ipilimumab Versus Nivolumab Monotherapy for Patients With Previously Untreated Advanced Renal Cell Carcinoma and Intermediate- or Poor-Risk Factors

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Mar 13, 2019
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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