An Investigational Immuno-therapy Study to Test Combination Treatments in Patients With Advanced Non-Small Cell Lung Cancer (FRACTION-Lung)

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)

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

Study Overview

• Status: Terminated
• Conditions: Advanced Cancer
• Intervention / Treatment: Drug: BMS-986205; Drug: Dasatinib; Biological: Relatlimab; Biological: Ipilimumab; Biological: Nivolumab

• Study Type: Interventional
• Enrollment (Actual): 295
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Clayton, Victoria, Australia
      • Local Institution
• Austria
  • Salzburg, Austria, 5020
    • Local Institution
• Canada
  • Edmonton, Canada, T6G 1Z2
    • Local Institution
  • Ontario
    • Hamilton, Ontario, Canada, L8V 5C2
      • Juravinski Cancer Centre, Hamilton Health Sciences-Mcmaster Univeristy's Faculty Of Health Sciences
    • Ottawa, Ontario, Canada, K1H 8L6
      • University Of Ottawa - The Ottawa Hospital Cancer centre
• France
  • Paris, France, 75005
    • Local Institution
  • Toulouse, France, 31059
    • Local Institution
  • Villejuif Cedex, France, 94805
    • Local Institution
• Italy
  • Milan, Italy, 20141
    • Local Institution
  • Milano, Italy, 20132
    • Local Institution
  • Rozzano, Italy, 20089
    • Local Institution
• Spain
  • Madrid, Spain, 28041
    • Local Institution
  • Madrid, Spain, 28050
    • Local Institution
  • Pamplona, Spain, 31008
    • Local Institution
• Switzerland
  • Lausanne, Switzerland, CH-1011
    • Local Institution
• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope National Medical Center
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
    • Los Angeles, California, United States, 90033
      • University of Southern California (USC)
    • Los Angeles, California, United States, 90095
      • University of Californa, Los Angeles (UCLA)
    • Newport Beach, California, United States, 92658
      • Hoag Memorial Hospital Presbyterian
    • San Diego, California, United States, 92122
      • University of California San Diego
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Yale Cancer Center
  • Kansas
    • Westwood, Kansas, United States, 66205
      • University of Kansas Cancer Center
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Sidney Kimmel Comprehensive Cancer Center
    • Baltimore, Maryland, United States, 21201
      • University of Maryland - Marlene and Stewart Greenebaum Cancer Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02215
      • Dana Farber/Harvard Cancer Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Health System (UMHS) - University Hospital (University of Michigan Medical Ce
    • Detroit, Michigan, United States, 48201
      • Karmanos Cancer Institute
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University, The Center for Advanced Medicine
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • Comprehensive Cancer Centers of Nevada
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • Univ of NC Shool of Medicine
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University
  • Oregon
    • Portland, Oregon, United States, 97225
      • Northwest Cancer Specialists
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
    • Philadelphia, Pennsylvania, United States, 19111-2497
      • Fox Chase Cancer Center
    • Pittsburgh, Pennsylvania, United States, 15217
      • University of Pittsburgh Medical Center
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • The West Clinic, P.C. d/b/a West Cancer Center
    • Nashville, Tennessee, United States, 37203
      • Sarah Cannon Cancer Center
  • Texas
    • Dallas, Texas, United States, 75246
      • Sammons Cancer Center (Uso)
    • Fort Worth, Texas, United States, 76104
      • Texas Oncology, P.A.
    • Houston, Texas, United States, 77030
      • The University of Texas MD Anderson Cancer Center
    • Tyler, Texas, United States, 75702
      • US Oncology
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Virginia Cancer Specialists, PC
  • Washington
    • Seattle, Washington, United States, 98109
      • University of Washington-Seattle Cancer Care Alliance

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Nivolumab; Nivolumab Monotherapy - Arm associated with this intervention is closed. Nivolumab is no longer given as an active comparator	Biological: Nivolumab; Arm associated with this intervention is closed. Nivolumab is no longer given as an active comparator.; Other Names: BMS-936558; MDX-1106; OPDIVO
EXPERIMENTAL: Nivolumab & Dasatinib; Nivolumab in combination with Dasatinib	Drug: Dasatinib; Other Names: BMS-354825; SPRYCEL; Biological: Nivolumab; Arm associated with this intervention is closed. Nivolumab is no longer given as an active comparator.; Other Names: BMS-936558; MDX-1106; OPDIVO
EXPERIMENTAL: Nivolumab & Relatlimab; Nivolumab in combination with Relatlimab	Biological: Relatlimab; Other Names: BMS-986016; Biological: Nivolumab; Arm associated with this intervention is closed. Nivolumab is no longer given as an active comparator.; Other Names: BMS-936558; MDX-1106; OPDIVO
EXPERIMENTAL: Nivolumab & Ipilimumab; Nivolumab in combination with Ipilimumab	Biological: Ipilimumab; Other Names: BMS-734016; Yervoy; Biological: Nivolumab; Arm associated with this intervention is closed. Nivolumab is no longer given as an active comparator.; Other Names: BMS-936558; MDX-1106; OPDIVO
EXPERIMENTAL: Nivolumab & BMS-986205; Nivolumab in combination with BMS- 986205	Drug: BMS-986205; Specified dose on specified days; Biological: Nivolumab; Arm associated with this intervention is closed. Nivolumab is no longer given as an active comparator.; Other Names: BMS-936558; MDX-1106; OPDIVO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)	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.	From first dose to 2 years following last dose (up to 30 months)
Duration of Response (DOR)	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.	From first dose to 2 years following last dose (up to 30 months)
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. 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.	From first dose to 24 weeks after first dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Experiencing Adverse Events (AEs)	This outcome measure describes the percentage of participants who experienced any grade, all causality AEs during the specified time frame	From first dose to 100 days following last dose
Percentage of Participants Experiencing Serious Adverse Events (SAEs)	This outcome measure describes the percentage of participants who experienced any grade, all causality SAEs during the specified time frame	From first dose to 100 days following last dose
Percentage of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation	This outcome measure describes the percentage of participants who experienced all causality AEs leading to discontinuation of study therapy during the specified time frame	From first dose to 100 days following last dose
Percentage of Participants Experiencing Death	This outcome measure describes the percentage of participants who died (due to any cause) during the specified time frame	From first dose to up to 45 months following first dose
Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests	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 Normal	From first dose to 100 days following last dose (approximately 9 months)
Number of Participants Experiencing Laboratory Abnormalities in Thyroid Tests	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=Thyroxine	From first dose to 100 days following last dose (approximately 9 months)

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 9, 2016
• Primary Completion (ACTUAL): January 29, 2020
• Study Completion (ACTUAL): January 29, 2020

Study Registration Dates

• First Submitted: April 21, 2016
• First Submitted That Met QC Criteria: April 22, 2016
• First Posted (ESTIMATE): April 25, 2016

Study Record Updates

• Last Update Posted (ACTUAL): March 22, 2021
• Last Update Submitted That Met QC Criteria: February 23, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Immunological; Protein Kinase Inhibitors; Immune Checkpoint Inhibitors; Nivolumab; Ipilimumab; Dasatinib; Linrodostat
• Other Study ID Numbers: CA018-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No