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An Immunotherapy Study of Nivolumab Plus Ipilimumab Versus Nivolumab Alone in Participants With Advanced Kidney Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03873402
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : March 17, 2020
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Biological: Nivolumab Biological: Ipilimumab Other: Ipilimumab placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 418 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : April 29, 2019
Estimated Primary Completion Date : January 28, 2022
Estimated Study Completion Date : January 27, 2025

Arm Intervention/treatment
Experimental: Nivolumab + ipilimumab Biological: Nivolumab
Specified dose on specified days
Other Name: Opdivo

Biological: Ipilimumab
Specified dose on specified days
Other Name: Yervoy

Experimental: Nivolumab + ipilimumab placebo Other: Ipilimumab placebo
Specified dose on specified days

Primary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: Up to 34 months ]
    Blinded independent central review (BICR) assessed per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1

  2. Objective Response Rate (ORR) [ Time Frame: Up to 23 months ]
    Including Complete Response (CR), by BICR per RECIST 1.1

Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: Up to 4 years ]
  2. Overall response rate (ORR) [ Time Frame: Up to 4 years ]
    BICR and investigator assessed per RECIST 1.1

  3. Disease control rate (DCR) [ Time Frame: Up to 4 years ]
  4. Duration of response (DoR) [ Time Frame: Up to 4 years ]
  5. Time to objective response (TTR) [ Time Frame: Up to 4 years ]
  6. PFS [ Time Frame: Up to 4 years ]
    investigator assessed per RECIST 1.1

  7. Incidence of adverse events (AEs) [ Time Frame: Up to 4 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit

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 CT or MRI per 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 could apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03873402

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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:
Contact: First line of the email MUST contain NCT # and Site #.

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Sponsors and Collaborators
Bristol-Myers Squibb
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb Identifier: NCT03873402    
Other Study ID Numbers: CA209-8Y8
2018-004695-35 ( EudraCT Number )
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual patient level data from this study may be shared with qualified researchers, upon request, following the timelines and process detailed on

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents