Phase II, Randomized, Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Renal Cell Carcinoma

Bristol-Myers Squibb6 sites in 3 countries104 target enrollmentFebruary 16, 2017

ConditionsRenal Cell Carcinoma

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Renal Cell Carcinoma
Sponsor: Bristol-Myers Squibb
Enrollment: 104
Locations: 6
Primary Endpoint: The Percentage of Participant With Adverse Events (AEs) in the Broad Scope MedDRA Anaphylactic Reaction Standardized MedDRA Queries (SMQ) Within 2 Days After Any Dose in the Combination Period
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate safety and efficacy of different administration regimens of nivolumab plus ipilimumab in subjects with renal cell carcinoma.

Registry

clinicaltrials.gov

Start Date

February 16, 2017

End Date

June 15, 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Advanced Renal Cell Carcinoma
•Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work
•Must have at least 1 lesion with measurable disease

Exclusion Criteria

•Subjects with active central nervous system metastases
•Subjects who received prior therapy with checkpoint inhibitor
•Subjects with active, known or suspected autoimmune disease
•Other protocol defined inclusion/exclusion criteria could apply

Outcomes

Primary Outcomes

The Percentage of Participant With Adverse Events (AEs) in the Broad Scope MedDRA Anaphylactic Reaction Standardized MedDRA Queries (SMQ) Within 2 Days After Any Dose in the Combination Period

Time Frame: From randomization to 2 days following any dose in the combination period (assessed up to November 24th, 2017, approximately 9 months)

The percentage of participants who experienced at least 1 adverse event in the MedDRA Anaphylactic Reaction broad scope SMQ with onset on the day of or within 2 days after any study therapy infusion during the combination period (Part 1).

Secondary Outcomes

Progression Free Survival (PFS)(From randomization to the first date of documented progression or death due to any cause (up to approximately 52 months))
The Percentage of Participant With Adverse Events in the Narrow Scope MedDRA Anaphylactic Reaction Standardized MedDRA Queries (SMQ) Occurring Within 2 Days After Any Dose in the Combination Period(From randomization to 2 days following any dose in the combination period (assessed up to November 24th, 2017, approximately 9 months))
The Percentage of Participants With All Causality Grade 3-5 Adverse Events(From first dose to 30 days after last dose of study therapy (up to approximately 48 months))
Objective Response Rate (ORR)(From randomization to the date of objectively documented progression or the date of first subsequent anti-cancer (up to approximately 52 months))
Geometric Mean End of Infusion (EOI) Concentrations of Nivolumab and Ipilimumab(EOI on day 1 of cycle 1, 2, and 4)
The Percentage of Participants With Drug Related Grade 3-5 Adverse Events(From first dose to 30 days after last dose of study therapy (up to approximately 48 months))
Geometric Mean Trough Concentrations of Nivolumab and Ipilimumab(pre-dose on day 1 of cycle 2 and 4)