A Study of Subcutaneous Nivolumab Versus Intravenous Nivolumab in Participants With Previously Treated Clear Cell Renal Cell Carcinoma That is Advanced or Has Spread (CheckMate-67T)

October 8, 2025 updated by: Bristol-Myers Squibb

A Phase 3, Open-label, Randomized, Noninferiority Trial of Subcutaneous Formulation of Nivolumab Versus Intravenous Nivolumab in Participants With Advanced or Metastatic Clear Cell Renal Cell Carcinoma Who Have Received Prior Systemic Therapy

The purpose of this study is to evaluate the drug levels, efficacy, safety, and tolerability of subcutaneous nivolumab versus intravenous nivolumab in participants with previously treated clear cell renal cell carcinoma that is advanced or has spread. The purpose of this study's substudy is to evaluate drug level biocomparability of subcutaneous nivolumab manufactured using two different manufacturing processes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
681

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
No longer available

No longer available

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Contact Backup

  • Name: First line of the email MUST contain NCT # and Site #.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1426ANZ
        • Local Institution - 0038
      • San Juan, Argentina, J5402DIL
        • Local Institution - 0056
    • Buenos Aires
      • Capital Federal, Buenos Aires, Argentina, C1419AHN
        • Local Institution - 0095
      • Mar del Plata, Buenos Aires, Argentina, 7600
        • Local Institution - 0058
      • Pergamino, Buenos Aires, Argentina, B2700CPM
        • Local Institution - 0037
    • Córdoba Province
      • Parana, Córdoba Province, Argentina, 5000
        • Local Institution - 0079
      • Río Cuarto, Córdoba Province, Argentina, 5800
        • Local Institution - 0030
    • Río Negro Province
      • Viedma, Río Negro Province, Argentina, R8500ACE
        • Local Institution - 0066
  • Brazil
      • Rio de Janeiro, Brazil, 20230-130
        • Local Institution - 0090
      • São Paulo, Brazil, 01246-000
        • Local Institution - 0081
      • São Paulo, Brazil, 01327-0001
        • Local Institution - 0096
    • Paraná
      • Curitiba, Paraná, Brazil, 80520-174
        • Local Institution - 0064
    • Rio Grande do Sul
      • Ijuí, Rio Grande do Sul, Brazil, 98700-000
        • Local Institution - 0107
      • Porto Alegre, Rio Grande do Sul, Brazil, 91350-200
        • Local Institution - 0039
    • São Paulo
      • Barretos, São Paulo, Brazil, 014784-000
        • Local Institution - 0071
      • São José do Rio Preto, São Paulo, Brazil, 15090-000
        • Local Institution - 0070
  • Chile
    • Región de Valparaíso
      • Viña del Mar, Región de Valparaíso, Chile, 2520598
        • Local Institution - 0077
    • Región de la Araucanía
      • Temuco, Región de la Araucanía, Chile
        • Local Institution - 0084
    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, Chile
        • Local Institution - 0005
      • Santiago, Santiago Metropolitan, Chile, 7500653
        • Local Institution - 0104
      • Santiago, Santiago Metropolitan, Chile, 7500921
        • Local Institution - 0076
  • Czechia
      • Brno, Czechia, 656 53
        • Local Institution - 0063
      • Hradec Králové, Czechia, 500 05
        • Local Institution - 0036
      • Olomouc, Czechia, 77900
        • Local Institution - 0020
      • Ostrava, Czechia, 708 52
        • Local Institution - 0099
      • Prague, Czechia, 140 59
        • Local Institution - 0010
      • Praha 8 Liben, Czechia, 18081
        • Local Institution - 0106
  • Finland
      • Tampere, Finland, 33521
        • Local Institution - 0017
  • France
      • Nice, France, 6189
        • Local Institution
      • Suresnes, France, 92151
        • Local Institution - 0051
      • Villejuif, France, 94800
        • Local Institution - 0068
  • Ireland
    • Dublin
      • Tallaght, Dublin, Ireland
        • Local Institution - 0060
  • Italy
      • Cremona, Italy, 26100
        • Local Institution - 0033
      • Florence, Italy, 50134
        • Local Institution - 0008
      • Meldola, Italy, 47014
        • Local Institution - 0027
      • Milan, Italy, 20141
        • Local Institution - 0018
      • Milan, Italy, 20133
        • Local Institution
      • Padua, Italy, 35128
        • Local Institution - 0014
      • Parma, Italy, 43126
        • Local Institution - 0082
      • Pavia, Italy, 27100
        • Local Institution - 0092
      • Roma, Italy, 00168
        • Local Institution - 0100
      • Rome, Italy, 00152
        • Local Institution - 0091
      • Terni, Italy, 05100
        • Local Institution - 0057
  • Mexico
      • Querétaro, Mexico, 76000
        • Local Institution - 0065
      • Querétaro, Mexico, 76090
        • Local Institution - 0085
      • San Luis Potosí City, Mexico, 78200
        • Local Institution - 0105
    • Coahuila
      • Torreón, Coahuila, Mexico, 27010
        • Local Institution - 0101
    • Mexico City
      • Tlalpan, Mexico City, Mexico, 14080
        • Local Institution - 0089
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Local Institution - 0103
      • Monterrey, Nuevo León, Mexico, 64710
        • Local Institution - 0031
  • New Zealand
      • Auckland, New Zealand, 1023
        • Local Institution - 0053
      • Hamilton, New Zealand, 3204
        • Local Institution - 0041
      • Palmerston North, New Zealand, 4414
        • Local Institution - 0078
  • Poland
      • Biała Podlaska, Poland, 21-500
        • Local Institution - 0055
      • Bydgoszcz, Poland, 85-796
        • Local Institution - 0062
      • Gdansk, Poland, 80-214
        • Local Institution - 0083
      • Krakow, Poland, 30-688
        • Local Institution - 0021
      • Krakow, Poland, 31-115
        • Local Institution - 0098
      • Poznan, Poland, 60-569
        • Local Institution - 0001
      • Warsaw, Poland, 02-781
        • Local Institution - 0023
  • Portugal
      • Coimbra, Portugal, 3030-075
        • Local Institution - 0050
      • Lisbon, Portugal, 1500-650
        • Local Institution - 0052
  • Romania
      • Bucharest, Romania, 022238
        • Local Institution - 0024
      • Cluj-Napoca, Romania, 400132
        • Local Institution - 0002
      • Cluj-Napoca, Romania, 400641
        • Local Institution - 0040
      • Craiova, Romania, 200347
        • Local Institution - 0016
  • Russia
      • Chelyabinsk, Russia, 454087
        • SBIH Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine
      • Ivanovo, Russia, 153040
        • Ivanovo Regional Oncology Dispensary
      • Moscow, Russia, 125284
        • Hertzen Moscow Oncology Research Center
      • Nizghiy Novgorod, Russia, 603000
        • Local Institution
      • Omsk, Russia, 644013
        • Budgetary Healthcare Institution of Omsk Region - Clinical Oncological Dispensary
      • Saint Petersburg, Russia, 197022
        • LLC Eurocityclinic
  • Spain
      • Barcelona, Spain, 08003
        • Local Institution - 0048
      • Barcelona, Spain, 08035
        • Local Institution - 0102
      • Barcelona, Spain, 08041
        • Local Institution - 0049
      • Madrid, Spain, 28026
        • Local Institution - 0072
      • Madrid, Spain, 28033
        • Local Institution - 0067
      • Madrid, Spain, 28046
        • Local Institution - 0074
      • Madrid, Spain, 28050
        • Local Institution - 0075
      • Sabadell, Spain, 08208
        • Local Institution - 0032
      • Santander, Spain, 39008
        • Local Institution - 0086
      • Seville, Spain, 31013
        • Local Institution - 0059
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06230
        • Local Institution - 0026
      • Ankara, Turkey (Türkiye), 06590
        • Local Institution - 0097
      • Istanbul, Turkey (Türkiye), 34098
        • Local Institution - 0019
    • Bagcilar
      • Istanbul, Bagcilar, Turkey (Türkiye), 34284
        • Local Institution - 0035
  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Local Institution
    • New York
      • Buffalo, New York, United States, 14263
        • Local Institution - 0025
    • Pennsylvania
      • West Reading, Pennsylvania, United States, 19611
        • Local Institution - 0088

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Inclusion Criteria:

  • Histological confirmation of renal cell carcinoma (RCC) with a clear cell component, including participants who may also have sarcomatoid features
  • Advanced RCC (not amenable to curative surgery or radiation therapy) or metastatic RCC (Stage IV)
  • Measurable disease as defined by Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 criteria within 28 days prior to randomization
  • Received no more than 2 prior systemic treatment regimens
  • Intolerance or progression on or after the last treatment regimen received and within 6 months prior to randomization
  • Karnofsky PS ≥ 70 at screening
  • Must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

  • Untreated, symptomatic central nervous system (CNS) metastases
  • Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to randomization
  • Active, known, or suspected autoimmune disease

  • Known human immunodeficiency virus (HIV) positive with an acquired immunodeficiency syndrome (AIDS) defining opportunistic infection within the last year, or a current CD4 count < 350 cells/μL. Participants with HIV are eligible if:

    1. They have received established antiretroviral therapy (ART) for at least 4 weeks prior to randomization
    2. They continue on ART as clinically indicated while enrolled on study
    3. CD4 counts and viral load are monitored per standard of care by a local health care provider
    4. Inclusion of participants with HIV should be based on Investigator clinical judgment in consultation with the Medical Monitor NOTE: Testing for HIV must be performed at sites where mandated locally. HIV-positive participants must be excluded where mandated locally
  • Serious or uncontrolled medical disorders including for example, active severe acute respiratory syndrome coronavirus 2 (SAR-CoV-2) infection within approximately 4 weeks prior to screening. In the case of prior SARS-CoV-2 infection, acute symptoms must have resolved based on investigator clinical judgment and, in consultation with Medical Monitor, there are no sequelae that would place the participant at a higher risk of receiving investigational treatment to be eligible
  • Prior treatment with an programmed death receptor-1 (anti-PD-1), programmed death ligand-1 (anti-PD-L1), or cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways
  • Treatment with any live attenuated vaccine within 30 days of first study treatment

Other protocol-defined inclusion/exclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm A
Biological: Nivolumab and rHuPH20
Specified dose on specified days
Other Names:
  • BMS-986298
Active Comparator: Arm B
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Experimental: Arm C
Biological: Nivolumab and rHuPH20
Specified dose on specified days
Other Names:
  • BMS-986298
Experimental: Arm D
Biological: Nivolumab and rHuPH20
Specified dose on specified days
Other Names:
  • BMS-986298

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Time-averaged serum concentration over 28 days (Cavgd28)
Time Frame: Up to 28 days
Up to 28 days
Trough serum concentration at steady-state (Cminss)
Time Frame: Up to 4 months
Up to 4 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Objective response rate (ORR) by Blinded Independent Central Review (BICR) with a minimum of 6 months follow-up
Time Frame: Up to 2 years 6 months
Up to 2 years 6 months
Trough serum concentration at day 28 (Cmind28)
Time Frame: At 28 days
At 28 days
Maximum serum concentration after the first dose (Cmax1)
Time Frame: Up to 7 days
Up to 7 days
Peak serum concentration at steady-state (Cmaxss)
Time Frame: Up to 4 months
Up to 4 months
Steady-state average serum concentration (Cavgss)
Time Frame: Up to 4 months
Up to 4 months
Incidence of adverse events (AEs)
Time Frame: Up to 2 years 3 months
Up to 2 years 3 months
Incidence of serious adverse events (SAEs)
Time Frame: Up to 2 years 3 months
Up to 2 years 3 months
Incidence of AEs leading to discontinuation
Time Frame: Up to 2 years
Up to 2 years
Incidence of deaths
Time Frame: Up to 5 years
Up to 5 years
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Time Frame: Up to 2 years 3 months
Up to 2 years 3 months
Incidence of clinically significant changes in clinical laboratory results: Chemistry panel tests
Time Frame: Up to 2 years 3 months
Up to 2 years 3 months
Efficacy parameters: disease control rate (DCR) by BICR with a minimum of 6 months follow-up
Time Frame: Up to 2 years 6 months
Up to 2 years 6 months
Efficacy parameters: DCR by BICR with a minimum of 12 months follow-up
Time Frame: Up to 3 years
Up to 3 years
Efficacy parameters: DCR by BICR at end of study
Time Frame: Up to 5 years
Up to 5 years
Efficacy parameters: duration of response (DOR) by BICR with a minimum of 6 months follow-up
Time Frame: Up to 2 years 6 months
Up to 2 years 6 months
Efficacy parameters: DOR by BICR with a minimum of 12 months follow-up
Time Frame: Up to 3 years
Up to 3 years
Efficacy parameters: DOR by BICR at end of study
Time Frame: Up to 5 years
Up to 5 years
Efficacy parameters: time to objective response (TTR) by BICR with a minimum of 6 months follow-up
Time Frame: Up to 2 years 6 months
Up to 2 years 6 months
Efficacy parameters: TTR by BICR with a minimum of 12 months follow-up
Time Frame: Up to 3 years
Up to 3 years
Efficacy parameters: TTR by BICR at end of study
Time Frame: Up to 5 years
Up to 5 years
Efficacy parameters: progression-free survival (PFS) by BICR with a minimum of 6 months follow-up
Time Frame: Up to 2 years 6 months
Up to 2 years 6 months
Efficacy parameters: PFS by BICR with a minimum of 12 months follow-up
Time Frame: Up to 3 years
Up to 3 years
Efficacy parameters: PFS by BICR at end of study
Time Frame: Up to 5 years
Up to 5 years
Efficacy parameters: overall survival (OS) with a minimum of 6 months follow-up
Time Frame: Up to 2 years 6 months
Up to 2 years 6 months
Efficacy parameters: OS with a minimum of 12 months follow-up
Time Frame: Up to 3 years
Up to 3 years
Efficacy parameters: OS at end of study
Time Frame: Up to 5 years
Up to 5 years
Efficacy parameters: ORR by BICR with a minimum of 12 months follow-up
Time Frame: Up to 3 years
Up to 3 years
Efficacy parameters: ORR by BICR at end of study
Time Frame: Up to 5 years
Up to 5 years
Incidence of local injection- or infusion-site reactions
Time Frame: Up to 2 years 3 months
Up to 2 years 3 months
Percentage of participants who develop anti-nivolumab antibodies, if applicable
Time Frame: Up to 2 years 3 months
Up to 2 years 3 months
Percentage of participants who develop neutralizing antibodies, if applicable
Time Frame: Up to 2 years 3 months
Up to 2 years 3 months
Trough concentration (Ctrough)
Time Frame: At week 17
At week 17
Incidence of anaphylactic, hypersensitivity, and systemic infusion reactions/systemic injection reactions
Time Frame: Up to 2 years 3 months
Up to 2 years 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 21, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 29, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 10, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 16, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 22, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 9, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CA209-67T
  • 2020-003655-15 (EudraCT Number)
  • U1111-1255-9514 (Registry Identifier: WHO)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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