Kidney Neoplasms Clinical Trial
— CheckMate 7C9Official title:
A Phase 4 Study of Nivolumab in Combination With Ipilimumab in Patients With Previously Untreated Advanced Renal Cell Carcinoma and Intermediate-or Poor-risk Factors Conducted in India
| Verified date | February 2024 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to assess the safety and efficacy of nivolumab combined with ipilimumab in intermediate and poor-risk participants with previously untreated advanced renal cell carcinoma (RCC) or metastatic RCC (mRCC) in India.
| Status | Completed |
| Enrollment | 101 |
| Est. completion date | January 4, 2024 |
| Est. primary completion date | January 4, 2024 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Histological confirmation of renal cell carcinoma (RCC) with clear cell component including participants who may have sarcomatoid features - Qualifies as intermediate or poor risk by meeting at least one of the prognostic factors as per the International Metastatic RCC Database Consortium (IMDC) criteria - Indian participants with Indian ethnicity living in India - No prior systemic therapy for RCC - Measurable disease lesion by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria Exclusion Criteria: - Participants with active, untreated, symptomatic central nervous system (CNS) metastases - Major surgery less than 28 days prior to the first dose of study treatment - Participants with an autoimmune disease, or any other condition, requiring systemic treatment with either corticosteroids or other immunosuppressive medications Other protocol-defined inclusion/exclusion criteria apply |
| Country | Name | City | State |
|---|---|---|---|
| India | Local Institution - 0005 | Ahmedabad | Gujarat |
| India | Local Institution - 0006 | Bangalore | |
| India | Local Institution - 0017 | Delhi | |
| India | Local Institution - 0002 | Karnataka | |
| India | Local Institution - 0019 | Kolkata | |
| India | Local Institution - 0001 | Mumbai | Maharashtra |
| India | Local Institution - 0013 | Mumbai | |
| India | Local Institution - 0016 | Mumbai | |
| India | Local Institution - 0007 | New Delhi | Delhi |
| India | Local Institution - 0012 | Pune | |
| India | Local Institution - 0011 | Trivandrum | Kerala |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
India,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of high-grade immune-mediated adverse events (IMAEs) assessed using Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Grade 3 to 4 and Grade 5 | Up to 54 weeks | ||
| Secondary | Time to onset of all high grade immune-mediated adverse events (IMAEs) assessed using Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Grade 3 to Grade 5 | Up to 54 weeks | ||
| Secondary | Time to resolution of all high grade IMAEs assessed using CTCAE v4.0 Grade 3 to Grade 5 | Up to 54 weeks | ||
| Secondary | Percentage of participants who received immune modulating medication in all high grade IMAEs assessed using CTCAE v4.0 Grade 3 to Grade 5 | Up to 54 weeks | ||
| Secondary | Objective Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 | Up to 52 weeks | ||
| Secondary | Time to Response (TTR) using RECIST 1.1 | Up to 52 weeks | ||
| Secondary | Duration of Response (DOR) using RECIST 1.1 | Up to 52 weeks |
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