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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)

  • Clinicaltrials.gov identifier

    NCT04513522

  • Recruitment Status

    Recruiting

  • First Posted

    August 14, 2020

  • Last update posted

    April 28, 2022

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.

  • Condition or Disease:Kidney Neoplasms
  • Intervention/Treatment: Biological: Nivolumab
    Biological: Ipilimumab
  • Phase: Phase 4

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 100 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Study to Evaluate the Safety and Efficacy of Nivolumab With Ipilimumab in Participants With Untreated Advanced Kidney Cancer Conducted in India
  • Actual Study Start Date: December 2020
  • Estimated Primary Completion Date: December 2023
  • Estimated Study Completion Date: December 2023

Arms and interventions

Arm Intervention/treatment
Experimental: Nivolumab + ipilimumab
Biological: Nivolumab
Specified dose on specified days

Biological: Ipilimumab
Specified dose on specified days

Outcome Measures

  • Primary Outcome Measures: 1. 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 Measures: 1. 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 ]
  • 2. Time to resolution of all high grade IMAEs assessed using CTCAE v4.0 Grade 3 to Grade 5 [ Time Frame: Up to 54 weeks ]
  • 3. 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 ]
  • 4. Objective Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [ Time Frame: Up to 52 weeks ]
  • 5. Time to Response (TTR) using RECIST 1.1 [ Time Frame: Up to 52 weeks ]
  • 6. Duration of Response (DOR) using RECIST 1.1 [ Time Frame: Up to 52 weeks ]

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Contacts

Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com

Contact: First line of the email MUST contain NCT # and Site #.

Locations

India, Kerala
Local Institution - 0011
Trivandrum

India
Local Institution - 0006
Bangalore

India
Local Institution - 0017
Delhi

India
Local Institution - 0002
Karnataka

India
Local Institution - 0019
Kolkata

India
Local Institution
Mumbai

India
Local Institution - 0016
Mumbai

India
Local Institution - 0013
Mumbai

India
Local Institution - 0007
New Delhi

India
Local Institution - 0012
Pune

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT04513522 History of Changes
  • Other Study ID Numbers: CA209-7C9
  • First Posted: August 14, 2020 Key Record Dates
  • Last Update Posted: April 28, 2022
  • Last Verified: April 2022
  • 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
  • Additional relevant MeSH terms: Kidney Neoplasms
    Urologic Neoplasms
    Urogenital Neoplasms
    Neoplasms by Site
    Neoplasms
    Kidney Diseases
    Urologic Diseases