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Clinical Trials/NCT02750514
NCT02750514
Terminated
Phase 2

A Phase 2, Fast Real Time Assessment of Combination Therapies in Immuno-Oncology Study in Subjects With Advanced Non-Small Cell Lung Cancer (FRACTION-Lung)

Bristol-Myers Squibb38 sites in 3 countries295 target enrollmentMay 9, 2016

Overview

Phase
Phase 2
Intervention
Relatlimab
Conditions
Advanced Cancer
Sponsor
Bristol-Myers Squibb
Enrollment
295
Locations
38
Primary Endpoint
Objective Response Rate (ORR)
Status
Terminated
Last Updated
5 years ago

Overview

Brief Summary

The purpose of this study is to determine whether Nivolumab, in combination with other therapies, is effective in patients with advanced Non-Small Cell lung cancer

Registry
clinicaltrials.gov
Start Date
May 9, 2016
End Date
January 29, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Advanced Non Small Cell Lung Cancer (NSCLC)
  • Eastern Cooperative Oncology Group (ECOG) Performance status of ≤ 1
  • Life expectancy of at least 3 months from most recent chemotherapy or immunotherapy treatment
  • Must have at least 1 lesion with measurable disease

Exclusion Criteria

  • Subjects with certain mutations that have not been treated with a targeted therapy prior to enrollment
  • Subjects who need daily oxygen therapy
  • People with autoimmune disease
  • Other protocol defined inclusion/exclusion criteria could apply

Arms & Interventions

Nivolumab & Relatlimab

Nivolumab in combination with Relatlimab

Intervention: Relatlimab

Nivolumab

Nivolumab Monotherapy - Arm associated with this intervention is closed. Nivolumab is no longer given as an active comparator

Intervention: Nivolumab

Nivolumab & Dasatinib

Nivolumab in combination with Dasatinib

Intervention: Nivolumab

Nivolumab & Dasatinib

Nivolumab in combination with Dasatinib

Intervention: Dasatinib

Nivolumab & Relatlimab

Nivolumab in combination with Relatlimab

Intervention: Nivolumab

Nivolumab & Ipilimumab

Nivolumab in combination with Ipilimumab

Intervention: Nivolumab

Nivolumab & Ipilimumab

Nivolumab in combination with Ipilimumab

Intervention: Ipilimumab

Nivolumab & BMS-986205

Nivolumab in combination with BMS- 986205

Intervention: Nivolumab

Nivolumab & BMS-986205

Nivolumab in combination with BMS- 986205

Intervention: BMS-986205

Outcomes

Primary Outcomes

Objective Response Rate (ORR)

Time Frame: From first dose to 2 years following last dose (up to 30 months)

ORR is defined as the percentage of participants whose confirmed best overall response (BOR) is either a complete response (CR) or partial response (PR). BOR was assessed by investigator per RECIST1.1. Results are presented by study track. Track 1 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = participants with prior anti-PD-1/PD-L1 therapy Track 4 = participants naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = participants with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3). Results for each study track are presented only for treatment groups who received a treatment in that specific track.

Duration of Response (DOR)

Time Frame: From first dose to 2 years following last dose (up to 30 months)

DOR, computed for all treated participants with a confirmed BOR of CR or PR, 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. Results are presented by study track. Track 1 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = participants with prior anti-PD-1/PD-L1 therapy Track 4 = participants naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = participants with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3). Results for each study track are presented only for treatment groups who received a treatment in that specific track.

Progression Free Survival Rate (PFSR) at 24 Weeks

Time Frame: From first dose to 24 weeks after first dose

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. Results are presented by study track. Track 1 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 positive (\>=1%) Track 2 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 negative (\<1%) Track 3 = participants with prior anti-PD-1/PD-L1 therapy Track 4 = participants naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = participants with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3). Results for each study track are presented only for treatment groups who received a treatment in that specific track.

Secondary Outcomes

  • Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests(From first dose to 100 days following last dose (approximately 9 months))
  • Percentage of Participants Experiencing Death(From first dose to up to 45 months following first dose)
  • Number of Participants Experiencing Laboratory Abnormalities in Thyroid Tests(From first dose to 100 days following last dose (approximately 9 months))
  • Percentage of Participants Experiencing Serious Adverse Events (SAEs)(From first dose to 100 days following last dose)
  • Percentage of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation(From first dose to 100 days following last dose)
  • Percentage of Participants Experiencing Adverse Events (AEs)(From first dose to 100 days following last dose)

Study Sites (38)

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