Clinical trial NCT02574078: A Study of Nivolumab in Advanced Non-Small Cell Lung Cancer (NSCLC)
Official title: A Master Protocol of Phase 1/2 Studies of Nivolumab in Advanced NSCLC Using Nivolumab as Maintenance After Induction Chemotherapy or as First-line Treatment Alone or in Combination With Standard of Care Therapies (CheckMate 370: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 370)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2015-10-12
Enrollment: 341
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether nivolumab monotherapy or in combination with Standard of care (SOC) therapies will provide clinical benefit (i.e., PFS, OS, and DOR) without unacceptable toxicity in advanced Non-Small Cell Lung Cancer patients.

Detailed description: Epidermal Growth Factor Receptor (EGFR), Anaplastic Lymphoma Kinase (ALK)

\*\*Please note that the study is no longer enrolling patients for Groups A, B, C, and E.

Eligibility criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Histologically confirmed locally advanced or stage IV NSCLC
* Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0-2
* Tumor tissue sections must be available for biomarker evaluation

Exclusion Criteria:

* Untreated or active/progressing Central Nervous system (CNS) metastases
* Active, known or suspected autoimmune disease
* Known history of testing positive for HIV or AIDS
* Active or chronic infection of hepatitis B virus or hepatitis C

Primary outcomes:
measure: Progression-Free Survival (PFS), Groups A-D Only
timeFrame: up to approximately 48 months
measure: Overall Survival (OS), Groups A-C Only
timeFrame: up to approximately 60 months
measure: Percentage of Participants With Treatment-related Adverse Events (AEs) Leading to Both Study Drugs Discontinuation, Group E Only
timeFrame: up to approximately 60 months
Secondary outcomes:
measure: Duration of Response (DOR), Groups A-D Only
timeFrame: up to approximately 48 months
measure: Objective Response Rate (ORR), Groups A-E
timeFrame: up to approximately 48 months
measure: Overall Survival (OS), Group D Only
timeFrame: up to approximately 60 months
measure: Progression-Free Survival (PFS), Group E Only
timeFrame: up to approximately 48 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Oncology
state: Alabama
city: Mobile
country: United States
facility: Southern Cancer Center Pc
state: Alabama
city: Glendale
country: United States
facility: Arizona Oncology Assoc, Pc-Hal
state: Arizona
city: Sedona
country: United States
facility: Northern Arizona Hematology & Oncology Associates
state: Arizona
city: Tucson
country: United States
facility: Arizona Oncol Assoc Dba (Hem Onc Physicians&Extenders) Hope
state: Arizona
city: Tucson
country: United States
facility: Arizona Clinical Research Center, Inc.
state: Arizona
city: Bakersfield
country: United States
facility: Comprehensive Blood And Cancer Center
state: California
city: Fullerton
country: United States
facility: St. Joseph Heritage Medical Group
state: California
city: La Jolla
country: United States
facility: Scripps Cancer Center
state: California
city: Los Angeles
country: United States
facility: UCLA Hematology/Oncology Clinic
state: California
city: San Luis Obispo
country: United States
facility: Coastal Integrative Cancer Care
state: California
city: Santa Maria
country: United States
facility: Central Coast Med Oncology
state: California
city: Solvang
country: United States
facility: Local Institution
state: California
city: Grand Junction
country: United States
facility: St. Mary's Hospital Regional Cancer Center
state: Colorado
city: Lakewood
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Norwich
country: United States
facility: Eastern Ct Hem Onc Assoc
state: Connecticut
city: Stamford
country: United States
facility: Stamford Hospital
state: Connecticut
city: West Haven
country: United States
facility: Va Ct Healthcare System
state: Connecticut
city: Fort Myers
country: United States
facility: Florida Cancer Specialists S.
state: Florida
city: Gainesville
country: United States
facility: University of Florida at Shands
state: Florida
city: Hollywood
country: United States
facility: Memorial Cancer Institute
state: Florida
city: Miami
country: United States
facility: Baptist Health Medical Group Oncology
state: Florida
city: Ocala
country: United States
facility: Ocala Oncology Center
state: Florida
city: Port Saint Lucie
country: United States
facility: Hematology Oncology Associates Of The Treasure Coast
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Memorial Cancer Center
state: Florida
city: Trinity
country: United States
facility: Florida Cancer Affiliates
state: Florida
city: Athens
country: United States
facility: University Cancer Blood Ctr
state: Georgia
city: Newnan
country: United States
facility: Cancer Treatment Centers Of America
state: Georgia
city: Savannah
country: United States
facility: Summit Cancer Care
state: Georgia
city: Thomasville
country: United States
facility: Lewis Hall Singletary Oncology Center
state: Georgia
city: Niles
country: United States
facility: Illinois Cancer Specialists
state: Illinois
city: Anderson
country: United States
facility: Community Clinical Research Center
state: Indiana
city: Fort Wayne
country: United States
facility: Ft. Wayne Med Onco-Hema Inc
state: Indiana
city: Topeka
country: United States
facility: Cotton-O-Neil Clinical Research Center
state: Kansas
city: Paducah
country: United States
facility: West KY Hematology Oncology Group PSC
state: Kentucky
city: Alexandria
country: United States
facility: Christus St. Francis Cabrini Cancer Center
state: Louisiana
city: Metairie
country: United States
facility: East Jefferson General Hospital
state: Louisiana
city: Scarborough
country: United States
facility: New England Cancer Specialists
state: Maine
city: Annapolis
country: United States
facility: Anne Arundel Medical Center
state: Maryland
city: Baltimore
country: United States
facility: University Of Maryland
state: Maryland
city: Baltimore
country: United States
facility: Sinai Hospital Of Baltimore
state: Maryland
city: Bethesda
country: United States
facility: Center For Cancer And Blood Disorders
state: Maryland
city: Columbia
country: United States
facility: Maryland Oncology Hematology, P.A.
state: Maryland
city: Easton
country: United States
facility: Bay Hematology Oncology
state: Maryland
city: Grand Rapids
country: United States
facility: Cancer & Hematology Centers Of Western Michigan
state: Michigan
city: Edina
country: United States
facility: Minnesota Oncology Hematology, P.A.
state: Minnesota
city: Hattiesburg
country: United States
facility: Forrest General Cancer Center
state: Mississippi
city: Jackson
country: United States
facility: Jackson Oncology Associates, Pllc
state: Mississippi
city: Bridgeton
country: United States
facility: St. Louis Cancer Care, Llp
state: Missouri
city: Billings
country: United States
facility: Saint Vincent Frontier Cancer Center
state: Montana
city: Lincoln
country: United States
facility: Southeast Nebraska Cancer Center
state: Nebraska
city: Omaha
country: United States
facility: Nebraska Cancer Specialists
state: Nebraska
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Flemington
country: United States
facility: Hunterdon Medical Center
state: New Jersey
city: Morristown
country: United States
facility: Summit Medical Group
state: New Jersey
city: Summit
country: United States
facility: Atlantic Health System
state: New Jersey
city: Summit
country: United States
facility: Morristown Medical Center
state: New Jersey
city: Farmington
country: United States
facility: San Juan Oncology Associates
state: New Mexico
city: Albany
country: United States
facility: New York Oncology Hematology, Pc
state: New York
city: Glens Falls
country: United States
facility: Glens Falls Hospital
state: New York
city: Johnson City
country: United States
facility: Broome Oncology
state: New York
city: Mount Kisco
country: United States
facility: Northern Westchester Hospital
state: New York
city: New York
country: United States
facility: Columbia University Medical Center (Cumc)
state: New York
city: Nyack
country: United States
facility: Hematology-Oncology Associates Of Rockland
state: New York
city: White Plains
country: United States
facility: White Plains Hospital
state: New York
city: Greensboro
country: United States
facility: Cone Health Cancer Center
state: North Carolina
city: Greensboro
country: United States
facility: Moses Cone Health System
state: North Carolina
city: Greensboro
country: United States
facility: Randolph Cancer Center
state: North Carolina
city: Pinehurst
country: United States
facility: First Health Of The Carolinas
state: North Carolina
city: Salisbury
country: United States
facility: W.G. Bill Hefner VA Medical Center
state: North Carolina
city: Bismarck
country: United States
facility: Cancer Care Center
state: North Dakota
city: Fargo
country: United States
facility: Sanford Health
state: North Dakota
city: Cincinnati
country: United States
facility: Oncology Hematology Care, Inc.
state: Ohio
city: Cleveland
country: United States
facility: Louis Stokes Cleveland VA Medical Center
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Columbus
country: United States
facility: Mid Ohio Oncology Hematology
state: Ohio
city: Tulsa
country: United States
facility: Oklahoma Cancer Specialists and Research Institute, LLC-Clinical Research
state: Oklahoma
city: Eugene
country: United States
facility: Oncology Associates Of Oregon, Pc
state: Oregon
city: Medford
country: United States
facility: Hematology Oncology Associates
state: Oregon
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
city: Bethlehem
country: United States
facility: St. Luke's University Hospital Bethlehem
state: Pennsylvania
city: Erie
country: United States
facility: Erie Regional Cancer Center
state: Pennsylvania
city: Horsham
country: United States
facility: Abington Hematology Oncology Associates, Inc
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Hematology Oncology Associates, Pa
state: South Carolina
city: Greenville
country: United States
facility: Greenville Health System
state: South Carolina
city: Sioux Falls
country: United States
facility: Sanford Research
state: South Dakota
city: Chattanooga
country: United States
facility: Chattanooga Oncology Hematology Associates
state: Tennessee
city: Germantown
country: United States
facility: The Jones Clinic, PC
state: Tennessee
city: Germantown
country: United States
facility: West Cancer Center
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC - SCRI - PPDS
state: Tennessee
city: Abilene
country: United States
facility: Texas Oncology-Abilene
state: Texas
city: Amarillo
country: United States
facility: Texas Oncology - Amarillo
state: Texas
city: Arlington
country: United States
facility: Texas Oncology-Arlington North
state: Texas
city: Austin
country: United States
facility: Texas Oncology-Central Austin Cancer Center
state: Texas
city: Beaumont
country: United States
facility: Texas Oncology-Beaumont
state: Texas
city: Bedford
country: United States
facility: Texas Oncology
state: Texas
city: Dallas
country: United States
facility: Texas Oncology/Methodist Charlton Cancer Ctr
state: Texas
city: Dallas
country: United States
facility: Texas Oncology
state: Texas
city: Dallas
country: United States
facility: Texas Oncology
state: Texas
city: Dallas
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Denton
country: United States
facility: Texas Oncology
state: Texas
city: El Paso
country: United States
facility: Texas Oncology
state: Texas
city: Flower Mound
country: United States
facility: Texas Oncology
state: Texas
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology
state: Texas
city: Fort Worth
country: United States
facility: The Center For Cancer And Blood Disorders
state: Texas
city: Houston
country: United States
facility: Texas Oncology
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Mesquite
country: United States
facility: Texas Cancer Center Of Mesquite
state: Texas
city: Midland
country: United States
facility: Texas Oncology, Pa
state: Texas
city: New Braunfels
country: United States
facility: Texas Oncology
state: Texas
city: Paris
country: United States
facility: Texas Oncology
state: Texas
city: Plano
country: United States
facility: Texas Oncology-Plano East
state: Texas
city: Plano
country: United States
facility: Texas Oncology Plano West Cancer Center
state: Texas
city: San Antonio
country: United States
facility: Cancer Centers of South Texas
state: Texas
city: Sherman
country: United States
facility: Texas Cancer Center - Sherman
state: Texas
city: Sugar Land
country: United States
facility: Texas Oncology Cancer Center - Sugar Land
state: Texas
city: Tyler
country: United States
facility: Texas Oncology-Tyler
state: Texas
city: Waco
country: United States
facility: Texas Oncology Cancer Care And Research Center
state: Texas
city: Webster
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Weslaco
country: United States
facility: Texas Oncology
state: Texas
city: Wichita Falls
country: United States
facility: Texas Oncology-Wichita Falls
state: Texas
city: Blacksburg
country: United States
facility: Oncology & Hematology Associates Of Southwest Virginia, Inc.
state: Virginia
city: Fairfax
country: United States
facility: Virginia Cancer Specialists, Pc
state: Virginia
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Richmond
country: United States
facility: Virginia Cancer Institute
state: Virginia
city: Winchester
country: United States
facility: Shenandoah Oncology
state: Virginia
city: Everett
country: United States
facility: Providence Regional Cancer Partnership
state: Washington
city: Spokane Valley
country: United States
facility: Cancer Care Northwest
state: Washington
city: Vancouver
country: United States
facility: Northwest Cancer Specialists, Pc
state: Washington
city: Yakima
country: United States
facility: Yakima Valley Memorial Hospital/North Star Lodge
state: Washington
city: Huntington
country: United States
facility: Edwards Comprehensive Cancer Center
state: West Virginia
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol Myers Squibb
role: STUDY_DIRECTOR
References: