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)

  • STATUS
    Recruiting
  • End date
    Jan 29, 2026
  • participants needed
    454
  • sponsor
    Bristol-Myers Squibb
Updated on 9 July 2022
measurable disease
carcinoma
nivolumab
curative surgery
clear cell renal cell carcinoma

Summary

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.

Details
Condition Clear Cell Renal Cell Carcinoma
Treatment Nivolumab, Nivolumab and rHuPH20
Clinical Study IdentifierNCT04810078
SponsorBristol-Myers Squibb
Last Modified on9 July 2022

Eligibility

Yes No Not Sure

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 on the study
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
They have received established antiretroviral therapy (ART) for at least 4 weeks prior to randomization
They continue on ART as clinically indicated while enrolled on study
CD4 counts and viral load are monitored per standard of care by a local health care provider
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
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
respiratory syndrome coronavirus 2 (SAR-CoV-2) infection within approximately
Treatment with any live attenuated vaccine within 30 days of first study treatment
weeks prior to screening. In the case of prior SARS-CoV-2 infection, acute
Other protocol-defined inclusion/exclusion criteria apply
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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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