An Investigational Immuno-therapy Study to Test Combination Treatments in Patients With Advanced Non-Small Cell Lung Cancer
- Conditions
- Advanced Cancer
- Interventions
- Registration Number
- NCT02750514
- Lead Sponsor
- Bristol-Myers Squibb
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 295
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nivolumab & Relatlimab Relatlimab Nivolumab in combination with Relatlimab Nivolumab Nivolumab Nivolumab Monotherapy - Arm associated with this intervention is closed. Nivolumab is no longer given as an active comparator Nivolumab & Dasatinib Nivolumab Nivolumab in combination with Dasatinib Nivolumab & Relatlimab Nivolumab Nivolumab in combination with Relatlimab Nivolumab & BMS-986205 Nivolumab Nivolumab in combination with BMS- 986205 Nivolumab & Ipilimumab Nivolumab Nivolumab in combination with Ipilimumab Nivolumab & Ipilimumab Ipilimumab Nivolumab in combination with Ipilimumab Nivolumab & BMS-986205 BMS-986205 Nivolumab in combination with BMS- 986205 Nivolumab & Dasatinib Dasatinib Nivolumab in combination with Dasatinib
- Primary Outcome Measures
Name Time Method Objective Response Rate (ORR) 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) 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 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 Outcome Measures
Name Time Method Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests From first dose to 100 days following last dose (approximately 9 months) The following measurements will be considered laboratory abnormalities for hepatic tests:
* ALT or AST \> 3 x ULN, \> 5 x ULN, \> 10 x ULN and \> 20 x ULN
* Total bilirubin \> 2 x ULN
* Concurrent (within 1 day) ALT or AST \> 3 x ULN and total bilirubin \> 2 x ULN
* Concurrent (within 30 days) ALT or AST \> 3 x ULN and total bilirubin \> 2 x ULN ALT=Alanine aminotransferase AST=Aspartate aminotransferase ULN=Upper Limit of NormalPercentage of Participants Experiencing Death From first dose to up to 45 months following first dose This outcome measure describes the percentage of participants who died (due to any cause) during the specified time frame
Number of Participants Experiencing Laboratory Abnormalities in Thyroid Tests From first dose to 100 days following last dose (approximately 9 months) The following measurements will be considered laboratory abnormalities for thyroid tests:
* TSH value \> ULN and
* With baseline TSH value ≤ ULN
* At least one T3/T4 test value \< LLN
* Low TSH \< LLN and
* With baseline TSH value ≥ LLN
* At least one T3/T4 test value \> ULN TSH = thyroid stimulating hormone ULN=Upper Limit of Normal LLN=Lower Limit of Normal T3=Triiodothyronine T4=ThyroxinePercentage of Participants Experiencing Serious Adverse Events (SAEs) From first dose to 100 days following last dose This outcome measure describes the percentage of participants who experienced any grade, all causality SAEs during the specified time frame
Percentage of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation From first dose to 100 days following last dose This outcome measure describes the percentage of participants who experienced all causality AEs leading to discontinuation of study therapy during the specified time frame
Percentage of Participants Experiencing Adverse Events (AEs) From first dose to 100 days following last dose This outcome measure describes the percentage of participants who experienced any grade, all causality AEs during the specified time frame
Related Research Topics
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Trial Locations
- Locations (38)
City of Hope National Medical Center
🇺🇸Duarte, California, United States
University of Southern California (USC)
🇺🇸Los Angeles, California, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
University of Californa, Los Angeles (UCLA)
🇺🇸Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian
🇺🇸Newport Beach, California, United States
University of California San Diego
🇺🇸San Diego, California, United States
University of Colorado Denver
🇺🇸Aurora, Colorado, United States
Yale Cancer Center
🇺🇸New Haven, Connecticut, United States
University of Kansas Cancer Center
🇺🇸Westwood, Kansas, United States
University of Maryland - Marlene and Stewart Greenebaum Cancer Center
🇺🇸Baltimore, Maryland, United States
Scroll for more (28 remaining)City of Hope National Medical Center🇺🇸Duarte, California, United States