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A Study to Evaluate the Safety and Efficacy of Nivolumab With Ipilimumab in Participants With Untreated Advanced Kidney Cancer Conducted in India (CheckMate 7C9)

Primary Purpose

Kidney Neoplasms

Status
Active
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Nivolumab
Ipilimumab
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Local Institution - 0007
  • Local Institution - 0005
  • Local Institution - 0011
  • Local Institution - 0001
  • Local Institution - 0006
  • Local Institution - 0017
  • Local Institution - 0002
  • Local Institution - 0019
  • Local Institution - 0016
  • Local Institution - 0013
  • Local Institution - 0012

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nivolumab + ipilimumab

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Time to resolution of all high grade IMAEs assessed using CTCAE v4.0 Grade 3 to Grade 5
Percentage of participants who received immune modulating medication in all high grade IMAEs assessed using CTCAE v4.0 Grade 3 to Grade 5
Objective Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Time to Response (TTR) using RECIST 1.1
Duration of Response (DOR) using RECIST 1.1

Full Information

First Posted
August 13, 2020
Last Updated
October 17, 2023
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT04513522
Brief Title
A Study to Evaluate the Safety and Efficacy of Nivolumab With Ipilimumab in Participants With Untreated Advanced Kidney Cancer Conducted in India
Acronym
CheckMate 7C9
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 17, 2020 (Actual)
Primary Completion Date
December 29, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nivolumab + ipilimumab
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
BMS-936558, Opdivo
Intervention Description
Specified dose on specified days
Intervention Type
Biological
Intervention Name(s)
Ipilimumab
Other Intervention Name(s)
BMS-734016, Yervoy
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
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
Time Frame
Up to 54 weeks
Secondary Outcome Measure Information:
Title
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
Time Frame
Up to 54 weeks
Title
Time to resolution of all high grade IMAEs assessed using CTCAE v4.0 Grade 3 to Grade 5
Time Frame
Up to 54 weeks
Title
Percentage of participants who received immune modulating medication in all high grade IMAEs assessed using CTCAE v4.0 Grade 3 to Grade 5
Time Frame
Up to 54 weeks
Title
Objective Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Time Frame
Up to 52 weeks
Title
Time to Response (TTR) using RECIST 1.1
Time Frame
Up to 52 weeks
Title
Duration of Response (DOR) using RECIST 1.1
Time Frame
Up to 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution - 0007
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110029
Country
India
Facility Name
Local Institution - 0005
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380054
Country
India
Facility Name
Local Institution - 0011
City
Trivandrum
State/Province
Kerala
ZIP/Postal Code
695011
Country
India
Facility Name
Local Institution - 0001
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400012
Country
India
Facility Name
Local Institution - 0006
City
Bangalore
ZIP/Postal Code
560017
Country
India
Facility Name
Local Institution - 0017
City
Delhi
ZIP/Postal Code
110085
Country
India
Facility Name
Local Institution - 0002
City
Karnataka
ZIP/Postal Code
560027
Country
India
Facility Name
Local Institution - 0019
City
Kolkata
ZIP/Postal Code
711103
Country
India
Facility Name
Local Institution - 0016
City
Mumbai
ZIP/Postal Code
400053
Country
India
Facility Name
Local Institution - 0013
City
Mumbai
ZIP/Postal Code
400056
Country
India
Facility Name
Local Institution - 0012
City
Pune
ZIP/Postal Code
411001
Country
India

12. IPD Sharing Statement

Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

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

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