Brief Summary

The purpose of this study is to test the effectiveness and safety of various nivolumab combinations compared to nivolumab and ipilimumab in participants with advanced kidney cancer

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

182

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Feb 2017

Longer than P75 for phase_2

Geographic Reach

5 countries

30 active sites

Status

completed

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

4.8 years study duration

First Submitted

Initial submission to the registry

December 15, 2016

Completed

4 days until next milestone

First Posted

Study publicly available on registry

December 19, 2016

Completed

2 months until next milestone

Study Start

First participant enrolled

February 2, 2017

Completed

4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2021

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2021

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

December 19, 2022

Completed

Last Updated

December 19, 2022

Status Verified

November 1, 2022

Enrollment Period

4.8 years

First QC Date

December 15, 2016

Results QC Date

November 18, 2022

Last Update Submit

November 18, 2022

Conditions

Advanced Cancer

Outcome Measures

Primary Outcomes (3)

Objective Response Rate (ORR) Per Investigator
ORR is percent of participants whose best overall response (BOR) is complete response (CR) or partial response (PR). BOR is the best response from the start of the study treatment until objectively documented progression per RECIST v1.1 or subsequent anticancer therapy, whichever occurs first. For participants who received re-treatment or were re-randomized, the re-treatment and re-randomized therapies were considered subsequent anticancer therapy. CR is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) have reduction in short axis to \<10 mm. PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The Response Evaluation Criteria in Solid Tumors (RECIST) is a standard way to measure the response of a tumor to treatment. CR+PR, confidence interval based on Clopper and Pearson method.
From first dose of study treatment until progression or subsequent anticancer therapy, whichever occurs first (assessed up to approximately 247 weeks)
Median Duration of Response (DOR) Per Investigator
Duration of Response is defined as the time between the date of first response and the date of first documented disease progression as determined by RECIST 1.1 or death due to any cause (death occurring after re-treatment or randomization to new combination treatment was not considered), whichever occurred first. Complete Response (CR) is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Median computed using Kaplan -Meier method
From first dose to the date of first documented disease progression or death due to any cause (assessed from an average of 22 weeks up to approximately 247 weeks)
Progression Free Survival Rate (PFSR) at 24 Weeks.
The PFSR at 24 weeks is defined as the proportion of treated participants remaining progression free and surviving at 24 weeks since the first dosing date. Progressive Disease (PD) is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Point estimates are derived from Kaplan-Meier analyses, the 95% CIs are derived from Greenwood formula
24 weeks after first treatment dose.

Secondary Outcomes (8)

Number of Participants With Adverse Events (AEs)
From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks)
Number of Participants With Serious Adverse Events (SAEs)
From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks)
Number of Participants With Adverse Events (AEs) Leading to Discontinuation
From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks)
Number of Participants Who Died
From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks)
Number of Participants With Abnormal Thyroid Test Results - Track 1
From first dose to 30 days after last dose of study therapy (approximately 108 weeks)
+3 more secondary outcomes

Study Arms (4)

Nivolumab + Ipilimumab

ACTIVE COMPARATOR

Nivolumab + Ipilimumab

Biological: NivolumabBiological: Ipilimumab

Nivolumab + Relatlimab

EXPERIMENTAL

Nivolumab + Relatlimab

Biological: NivolumabBiological: Relatlimab

Nivolumab + BMS-986205

EXPERIMENTAL

Nivolumab + BMS-986205

Biological: NivolumabDrug: BMS-986205

Nivolumab + BMS-813160

EXPERIMENTAL

Nivolumab + BMS-813160 (CCR2/5 dual antagonist)

Biological: NivolumabDrug: BMS-813160