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Clinical Trials/CTIS2023-508264-29-00
CTIS2023-508264-29-00RecruitingPhase 1

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 - CA209-8Y8

Bristol Myers Squibb International Corporation0 sites448 target enrollmentStarted: December 15, 2023Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Recruiting
Enrollment
448
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18 to 65+ (—)
Sex
All

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

Investigators

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