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

Advanced Cancer Clinical Trial

— FRACTION-Lung  

Official title:

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02750514
• Other study ID #: CA018-001
• Status: Terminated
• Phase: Phase 2
• Start date: May 9, 2016
• Est. completion date: January 29, 2020

Study information

• Verified date: February 2021
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 295
• Est. completion date: January 29, 2020
• Est. primary completion date: January 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Cancer
• Carcinoma, Non-Small-Cell Lung

Intervention

Biological:
• Nivolumab
Arm associated with this intervention is closed. Nivolumab is no longer given as an active comparator.

Drug:
• Dasatinib

Biological:
• Relatlimab

• Ipilimumab

Drug:
• BMS-986205
Specified dose on specified days

Locations

Country	Name	City	State
Australia	Local Institution	Clayton	Victoria
Austria	Local Institution	Salzburg
Canada	Local Institution	Edmonton
Canada	Juravinski Cancer Centre, Hamilton Health Sciences-Mcmaster Univeristy's Faculty Of Health Sciences	Hamilton	Ontario
Canada	University Of Ottawa - The Ottawa Hospital Cancer centre	Ottawa	Ontario
France	Local Institution	Paris
France	Local Institution	Toulouse
France	Local Institution	Villejuif Cedex
Italy	Local Institution	Milan
Italy	Local Institution	Milano
Italy	Local Institution	Rozzano
Spain	Local Institution	Madrid
Spain	Local Institution	Madrid
Spain	Local Institution	Pamplona
Switzerland	Local Institution	Lausanne
United States	University of Michigan Health System (UMHS) - University Hospital (University of Michigan Medical Ce	Ann Arbor	Michigan
United States	University of Colorado Denver	Aurora	Colorado
United States	Sidney Kimmel Comprehensive Cancer Center	Baltimore	Maryland
United States	University of Maryland - Marlene and Stewart Greenebaum Cancer Center	Baltimore	Maryland
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana Farber/Harvard Cancer Center	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Univ of NC Shool of Medicine	Chapel Hill	North Carolina
United States	The Ohio State University	Columbus	Ohio
United States	Sammons Cancer Center (Uso)	Dallas	Texas
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	City of Hope National Medical Center	Duarte	California
United States	Virginia Cancer Specialists, PC	Fairfax	Virginia
United States	Texas Oncology, P.A.	Fort Worth	Texas
United States	The West Clinic, P.C. d/b/a West Cancer Center	Germantown	Tennessee
United States	The University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	University of Californa, Los Angeles (UCLA)	Los Angeles	California
United States	University of Southern California (USC)	Los Angeles	California
United States	Sarah Cannon Cancer Center	Nashville	Tennessee
United States	Yale Cancer Center	New Haven	Connecticut
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Hoag Memorial Hospital Presbyterian	Newport Beach	California
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Northwest Cancer Specialists	Portland	Oregon
United States	Washington University, The Center for Advanced Medicine	Saint Louis	Missouri
United States	Huntsman Cancer Institute	Salt Lake City	Utah
United States	University of California San Diego	San Diego	California
United States	University of Washington-Seattle Cancer Care Alliance	Seattle	Washington
United States	Us Oncology	Tyler	Texas
United States	University of Kansas Cancer Center	Westwood	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Canada,  France,  Italy,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)

External Links

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