Clinical trial NCT04513522: A Study to Evaluate the Safety and Efficacy of Nivolumab With Ipilimumab in Participants With Untreated Advanced Kidney Cancer Conducted in India
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Neoplasms
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2020-08-14
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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
timeFrame: Up to 54 weeks
Secondary outcomes:
measure: 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
timeFrame: Up to 54 weeks
measure: Time to resolution of all high grade IMAEs assessed using CTCAE v4.0 Grade 3 to Grade 5
timeFrame: Up to 54 weeks
measure: Percentage of participants who received immune modulating medication in all high grade IMAEs assessed using CTCAE v4.0 Grade 3 to Grade 5
timeFrame: Up to 54 weeks
measure: Objective Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
timeFrame: Up to 52 weeks
measure: Time to Response (TTR) using RECIST 1.1
timeFrame: Up to 52 weeks
measure: Duration of Response (DOR) using RECIST 1.1
timeFrame: Up to 52 weeks
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Local Institution - 0007
state: Delhi
city: Ahmedabad
country: India
facility: Local Institution - 0005
state: Gujarat
city: Trivandrum
country: India
facility: Local Institution - 0011
state: Kerala
city: Mumbai
country: India
facility: Local Institution - 0001
state: Maharashtra
city: Bangalore
country: India
facility: Local Institution - 0006
city: Delhi
country: India
facility: Local Institution - 0017
city: Karnataka
country: India
facility: Local Institution - 0002
city: Kolkata
country: India
facility: Local Institution - 0019
city: Mumbai
country: India
facility: Local Institution - 0016
city: Mumbai
country: India
facility: Local Institution - 0013
city: Pune
country: India
facility: Local Institution - 0012
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: