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)
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
Investigators
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)