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

Phase 1

Recruiting

Conditions: Advanced Renal Cell Carcinoma with Intermediate- or Poor-Risk Factors
MedDRA version: 21.1Level: PTClassification code: 10067946Term: Renal cell carcinoma Class: 100000004864
Therapeutic area: Diseases [C] - Neoplasms [C04]

Registration Number: CTIS2023-508264-29-00

Lead Sponsor: Bristol Myers Squibb International Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 448

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: - To compare the PFS using RECIST 1.1 of nivolumab combined with ipilimumab and nivolumab and placebo in all randomized participants<br>- To compare the ORR using RECIST 1.1 of nivolumab combined with ipilimumab and nivolumab and placebo in all randomized participants;Secondary Objective: To compare the OS of nivolumab combined with ipilimumab and nivolumab and placebo in all randomized participants, To evaluate additional efficacy measures in all randomized participants., To estimate the incidence of AEs of nivolumab combined with ipilimumab and nivolumab and placebo in all treated participants, To investigate whether gene expression (GEP) signatures related to clear cell RCC (ccRCC) enrich for clinical benefit with nivolumab combined with ipilimumab and nivolumab and placebo in all randomized participants, To explore association of baseline PD-L1 expression on tumor with clinical benefit;Primary end point(s): Progression free survival (PFS) by BICR, Overall Response Rate (ORR) by BICR

Secondary Outcome Measures