A Study to Evaluate the Safety and Efficacy of Nivolumab With Ipilimumab in Participants With Untreated Advanced Kidney Cancer Conducted in India

Phase 4

Completed

• Conditions: Kidney Neoplasms
• Interventions: Biological: Nivolumab; Biological: Ipilimumab

• Registration Number: NCT04513522
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-13
• Study First Submitted QC: 2020-08-13
• Study First Posted: 2020-08-14
• Study Start: 2020-12-17
• Primary Completion: 2024-01-04
• Study Completion: 2024-01-04
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-12
• Last Update Posted: 2024-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nivolumab + ipilimumab	Ipilimumab	-
Nivolumab + ipilimumab	Nivolumab	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Time to Response (TTR) using RECIST 1.1	Up to 52 weeks
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
Objective Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1	Up to 52 weeks
Time to resolution of all high grade IMAEs assessed using CTCAE v4.0 Grade 3 to Grade 5	Up to 54 weeks
Duration of Response (DOR) using RECIST 1.1	Up to 52 weeks

Trial Locations

Locations (11)

Local Institution - 0002; 🇮🇳 Karnataka, India

Local Institution - 0007; 🇮🇳 New Delhi, Delhi, India

Local Institution - 0011; 🇮🇳 Trivandrum, Kerala, India

Local Institution - 0013; 🇮🇳 Mumbai, India

Local Institution - 0006; 🇮🇳 Bangalore, India

Local Institution - 0016; 🇮🇳 Mumbai, India

Local Institution - 0001; 🇮🇳 Mumbai, Maharashtra, India

Local Institution - 0017; 🇮🇳 Delhi, India

Local Institution - 0005; 🇮🇳 Ahmedabad, Gujarat, India

Local Institution - 0019; 🇮🇳 Kolkata, India

Local Institution - 0012; 🇮🇳 Pune, India