A Study to Evaluate the Safety and Efficacy of Nivolumab With Ipilimumab in Participants With Untreated Advanced Kidney Cancer Conducted in India
CheckMate 7C9
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
1 other identifier
interventional
101
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Dec 2020
Typical duration for phase_4
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 13, 2020
CompletedFirst Posted
Study publicly available on registry
August 14, 2020
CompletedStudy Start
First participant enrolled
December 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 4, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 4, 2024
CompletedResults Posted
Study results publicly available
July 11, 2025
CompletedJuly 11, 2025
July 1, 2025
3 years
August 13, 2020
December 10, 2024
July 9, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Total Number of Participants Experiencing High Grade Immune-Mediated Adverse Events (IMAE)
IMAEs are a type of adverse event that occurs when the immune system reacts against the body's own tissues, including diarrhea/colitis, hepatitis, pneumonitis, nephritis and renal dysfunction, rash, and endocrine (adrenal insufficiency, hypophysitis, hypothyroidism/thyroiditis, hyperthyroidism, and diabetes mellitus). IMAE analyses includes events, regardless of causality, which occurred during the study and follow-up. Only participants who received immune-modulating medication for treatment of the event are reported, with the exception of endocrine events, which will be included regardless of treatment since these events are often managed without immunosuppression. High grade (Grade 3 to 4 and Grade 5) IMAEs are reported. IMAEs are graded on a scale from 1 to 5, in which Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events may require hospitalization; Grade 5 events are fatal.
From first dose until 100 days after the last dose or for a maximum of 52 weeks from the date of the first on-study dose of nivolumab, whichever occurs earlier.
Secondary Outcomes (6)
Time to Onset of High Grade Immune-Mediated Adverse Event (IMAE)
From first dose until onset of IMAE (up to approximately 15 months)
Time to Resolution of High Grade Immune-Mediated Adverse Event (IMAE)
From first dose until resolution of IMAE (up to approximately 15 months)
The Number of Participants Who Received Immune-Modulating Medication
From first dose up to 100 days after last dose (up to approximately 15 months)
Objective Response Rate (ORR)
From first dose up to 100 days after last dose (up to approximately 15 months)
Time to Response (TTR)
From first dose to the date of CR or PR (up to approximately 15 months)
- +1 more secondary outcomes
Study Arms (1)
Nivolumab + ipilimumab
EXPERIMENTALInterventions
Specified dose on specified days
Specified dose on specified days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Local Institution - 0005
Ahmedabad, Gujarat, 380054, India
Local Institution - 0011
Trivandrum, Kerala, 695011, India
Local Institution - 0013
Mumbai, Maharashtra, 400 057, India
Local Institution - 0001
Mumbai, Maharashtra, 400012, India
Local Institution - 0007
New Delhi, National Capital Territory of Delhi, 110029, India
Local Institution - 0006
Bangalore, 560017, India
Local Institution - 0017
Delhi, 110085, India
Local Institution - 0002
Karnataka, 560027, India
Local Institution - 0019
Kolkata, 711103, India
Local Institution - 0016
Mumbai, 400053, India
Local Institution - 0012
Pune, 411001, India
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2020
First Posted
August 14, 2020
Study Start
December 17, 2020
Primary Completion
January 4, 2024
Study Completion
January 4, 2024
Last Updated
July 11, 2025
Results First Posted
July 11, 2025
Record last verified: 2025-07