Clinical trial NCT02066636: A Safety Trial of Nivolumab in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed During or After Receiving At Least One Prior Chemotherapy Regimen
Official title: A Phase IIIb/IV Safety Trial of Nivolumab (BMS-936558) in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed During or After Receiving At Least One Prior Systemic Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non Small Cell Lung Cancer (NSCLC)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2014-02-19
Enrollment: 1428
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 estimate the incidence and characterize the outcome of high grade, select adverse events in subjects with advanced or metastatic NSCLC treated with Nivolumab.


Eligibility criteria: Inclusion Criteria:

1. Target Population

* Subjects with histologically-or cytologically-documented NSCLC \[squamous (SQ) or nonsquamous (NSQ)\] who present with Stage IIIB/Stage IV disease (according to version 7 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology), or with recurrent or progressive disease following multimodal therapy (radiation therapy, surgical resection or definitive chemoradiotherapy for locally advanced disease)
* Subjects must have experienced disease progression or recurrence during or after at least one systemic therapy for advanced or metastatic disease
* Each subsequent line of therapy must be preceded by disease progression. A switch of an agent within a regimen in order to manage toxicity does not define the start of a new line of therapy
* Maintenance therapy following platinum doublet-based chemotherapy is not considered as a separate regimen of therapy
* Subjects who received platinum-containing adjuvant, neoadjuvant or definitive chemoradiation therapy given for locally advanced disease, and developed recurrent (local or metastatic) disease within 6 months of completing therapy are eligible
* Subjects with recurrent disease \>6 months after platinum-containing adjuvant, neoadjuvant or definitive chemoradiation therapy given for locally advanced disease, who also subsequently progressed during or after a platinum doublet-based regimen given to treat the recurrence are eligible
* Subjects with non-squamous histology must be tested for Epithelial Growth Factor Receptor (EGFR) mutations (including, but not limited to, deletions in exon 19 and exon 21 \[L858R\] substitution) and Anaplastic Lymphoma Kinase (ALK) rearrangement if tests have not been previously performed. Subjects with progressive disease during or after EGFR or ALK tyrosine kinase inhibitor (TKI) regimens are eligible. Subjects are eligible if genetic test results are indeterminate or if no tumor tissue is available or accessible for testing as long as they have received one prior systemic therapy
* Experimental therapies when given as separate regimen are considered as separate line of therapy
* Subjects must have measurable disease by CT or MRI per RECIST 1.1 criteria (radiographic tumor assessment performed within 28 days of first dose of study drug) or clinically apparent disease that the investigator can follow for response per RECIST 1.1
* Eastern Cooperative Oncology Arm (ECOG) performance status (PS)
* PS 0 to 1
* PS 2

Exclusion Criteria:

1. Target Disease Exceptions

   * Subjects with active central nervous system (CNS) metastases are excluded
   * Subjects with carcinomatous meningitis
2. Medical History and Concurrent Diseases

   * Subjects with a history of interstitial lung disease
   * Subjects with active, known or suspected autoimmune disease
   * Subject whom participated in either arm of the following clinical trials CA209-017, CA209-057, CA209-026, and CA184-104 or received prior treatment with anti-programmed death 1 (PD-1) or anti-programmed death-ligand 1 (PDL1) experimental agents
3. Prohibited Treatments and/or Restricted Therapies

   * Ongoing or planned administration of anti-cancer therapies other than those specified in this study
   * Use of corticosteroids or other immunosuppressive medications

Primary outcomes:
measure: The Number of Participants With Treatment Related Select Adverse Events (Grade 3-4 and Grade 5)
timeFrame: From first dose and 100 days after last dose (last dose up to randomization for cohort B) (up to approximately 88 months)
Secondary outcomes:
measure: Median Time to Onset of Select Adverse Events (Grade 3-5)
timeFrame: From first dose and 100 days after last dose (last dose up to randomization for cohort B) (up to approximately 88 months)
measure: Median Time to Resolution of Select Adverse Events (Grade 3-5)
timeFrame: From first dose and 100 days after last dose (last dose up to randomization for cohort B) (up to approximately 88 months)
measure: The Number of Participants Who Received Immune Modulating Medication (or Hormonal Replacement Therapy) for Any Grade Select Adverse Events
timeFrame: From first dose and 100 days after last dose (last dose up to randomization for cohort B) (up to approximately 88 months)
measure: The Number of Participants Who Received ≥ 40 mg Prednisone Equivalents for Any Grade Select Adverse Events
timeFrame: From first dose and 100 days after last dose (last dose up to randomization for cohort B) (up to approximately 88 months)
measure: The Total Duration of All Immune Modulating Medications for Any Grade Select Adverse Events
timeFrame: From first dose first dose and 100 days after last dose (last dose up to randomization for cohort B) (up to approximately 88 months)
measure: The Number of Participants With High Grade (Grade 3-4 and Grade 5) Select Adverse Events
timeFrame: From first dose and 100 days after last dose (last dose up to randomization for cohort B) (up to approximately 88 months)
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Southern Cancer Center Pc
state: Alabama
city: Goodyear
country: United States
facility: Cancer Center Treatment Center of America
state: Arizona
city: Phoenix
country: United States
facility: Arizona Oncology Associates
state: Arizona
city: Sedona
country: United States
facility: Arizona Oncology Associates
state: Arizona
city: Tucson
country: United States
facility: Arizona Oncol Assoc Dba (Hem Onc Physicians&Extenders) Hope
state: Arizona
city: Bakersfield
country: United States
facility: Comprehensive Blood And Cancer Center
state: California
city: Concord
country: United States
facility: Diablo Valley Oncology
state: California
city: Fullerton
country: United States
facility: Saint Jude Heritage Medical Group Virginia K Crosson Cancer Center
state: California
city: Los Angeles
country: United States
facility: Ucla Hema/Onc-Santa Monica
state: California
city: Monterey
country: United States
facility: Pacific Cancer Care
state: California
city: Sacramento
country: United States
facility: Sutter Cancer Center
state: California
city: San Francisco
country: United States
facility: Local Institution
state: California
city: San Luis Obispo
country: United States
facility: Central Coast Med Oncology
state: California
city: Santa Barbara
country: United States
facility: Sansum Santa Barbara Medical Foundation Clinic
state: California
city: Santa Maria
country: United States
facility: Central Coast Med Oncology
state: California
city: Torrance
country: United States
facility: Torrance Memorial Medical Center
state: California
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Golden
country: United States
facility: Mountain Blue Cancer Care Center
state: Colorado
city: Grand Junction
country: United States
facility: St. Mary's Hospital Regional Cancer Center
state: Colorado
city: Norwich
country: United States
facility: Eastern Ct Hem Onc Assoc
state: Connecticut
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital Inc.
state: Florida
city: Fort Myers
country: United States
facility: Florida Cancer Specialists S.
state: Florida
city: Jacksonville
country: United States
facility: Baptist Cancer Institute
state: Florida
city: Lakeland
country: United States
facility: Local Institution - 0031
state: Florida
city: Miami
country: United States
facility: Local Institution - 0038
state: Florida
city: Ocala
country: United States
facility: Ocala Oncology Center
state: Florida
city: Orlando
country: United States
facility: Cancer Institute Of Florida
state: Florida
city: Pemroke Pines
country: United States
facility: Memorial Cancer Institute
state: Florida
city: Pensacola
country: United States
facility: Local Institution - 0071
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: Tampa
country: United States
facility: Local Institution - 0108
state: Florida
city: Titusville
country: United States
facility: Space Coast Cancer Center
state: Florida
city: Athens
country: United States
facility: University Cancer Blood Ctr
state: Georgia
city: Atlanta
country: United States
facility: Piedmont Hospital
state: Georgia
city: Macon
country: United States
facility: Central Georgia Cancer Care, Pc
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: Valdosta
country: United States
facility: Pearlman Cancer Center
state: Georgia
city: Chicago
country: United States
facility: University Of Illinois Cancer Center
state: Illinois
city: Niles
country: United States
facility: Illinois Cancer Specialists
state: Illinois
city: Park Ridge
country: United States
facility: Oncology Specialists
state: Illinois
city: Quincy
country: United States
facility: Quincy Medical Group
state: Illinois
city: Skokie
country: United States
facility: Local Institution - 0015
state: Illinois
city: Springfield
country: United States
facility: Southern Illinois University School Of Medicine
state: Illinois
city: Fort Wayne
country: United States
facility: Local Institution - 0081
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Health Melvin And Bren Simon Cancer Center
state: Indiana
city: Wichita
country: United States
facility: Cancer Center Of Kansas
state: Kansas
city: Louisville
country: United States
facility: Norton Cancer Center
state: Kentucky
city: Louisville
country: United States
facility: University Medical Center, Inc
state: Kentucky
city: Paducah
country: United States
facility: West KY Hematology Oncology Group PSC
state: Kentucky
city: Shreveport
country: United States
facility: Christus Schumpert Health
state: Louisiana
city: Brewer
country: United States
facility: Local Institution
state: Maine
city: Annapolis
country: United States
facility: Anne Arundel Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Greater Baltimore Medical Center
state: Maryland
city: Bethesda
country: United States
facility: Walter Reed National Mltry Medical Center
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: Ann Arbor
country: United States
facility: Michigan Cancer Research Consortinum
state: Michigan
city: Grand Rapids
country: United States
facility: Cancer & Hematology Centers Of Western Michigan
state: Michigan
city: Southfield
country: United States
facility: Providence Cancer Center
state: Michigan
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: Tupelo
country: United States
facility: North Mississippi Hematology And Oncology Associates, Ltd
state: Mississippi
city: North Kansas City
country: United States
facility: University Of Kansas Cancer Center
state: Missouri
city: Springfield
country: United States
facility: Mercy Medical Research Institute
state: Missouri
city: Lincoln
country: United States
facility: Southeast Nebraska Hematology & Oncology Consultants, P.C.
state: Nebraska
city: Omaha
country: United States
facility: Nebraska Cancer Specialists
state: Nebraska
city: Las Vegas
country: United States
facility: Comprehensive Cancer Center Of Nevada
state: Nevada
city: Reno
country: United States
facility: VA Sierra Nevada Health Care System
state: Nevada
city: Flemington
country: United States
facility: Hunterdon Medical Center
state: New Jersey
city: Summit
country: United States
facility: Atlantic Health System
state: New Jersey
city: Albuquerque
country: United States
facility: Presbyterian Medical Group
state: New Mexico
city: Albany
country: United States
facility: St. Peters Hospital
state: New York
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
city: Fresh Meadows
country: United States
facility: Queens Medical Associates
state: New York
city: Johnson City
country: United States
facility: Broome Oncology
state: New York
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
city: Mount Kisco
country: United States
facility: Mount Kisco Medical Group
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: Asheboro
country: United States
facility: Randolph Cancer Center
state: North Carolina
city: Goldsboro
country: United States
facility: Southeastern Medical Oncology Center
state: North Carolina
city: Greensboro
country: United States
facility: Moses Cone Regional Cancer Center
state: North Carolina
city: Greeville
country: United States
facility: East Carolina University Leo W. Jenkins Cancer Center
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: Mid Dakota Clinic, Pc
state: North Dakota
city: Cincinnati
country: United States
facility: Oncology Hematology Care, Incorporated
state: Ohio
city: Cleveland
country: United States
facility: Local Institution
state: Ohio
city: Columbus
country: United States
facility: Zangmeister Cancer Center
state: Ohio
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: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
city: Langhorne
country: United States
facility: St. Mary Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Hematology Oncology Associates, Pa
state: South Carolina
city: Columbia
country: United States
facility: South Carolina Oncology Associates
state: South Carolina
city: Greenville
country: United States
facility: Greenville Health System
state: South Carolina
city: Chattanooga
country: United States
facility: Tennessee Oncology, PLLC - SCRI - PPDS
state: Tennessee
city: Germantown
country: United States
facility: Cancer Care Of Wnc
state: Tennessee
city: Germantown
country: United States
facility: The Jones Clinic, PC
state: Tennessee
city: Germantown
country: United States
facility: The West Clinic, P.C.
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology, Pllc
state: Tennessee
city: Nashville
country: United States
facility: Henry-Joyce Cancer Center
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
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
state: Texas
city: Dallas
country: United States
facility: Texas Oncology
state: Texas
city: Dallas
country: United States
facility: Local Institution - 0067
state: Texas
city: Denton
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: Northwest Cancer Center
state: Texas
city: McAllen
country: United States
facility: Texas Oncology
state: Texas
city: Mesquite
country: United States
facility: Texas Oncology
state: Texas
city: Midland
country: United States
facility: Texas Oncology - Odessa
state: Texas
city: Plano
country: United States
facility: Texas Oncology-Plano East
state: Texas
city: San Antonio
country: United States
facility: Cancer Care Centers Of South Texas
state: Texas
city: Sherman
country: United States
facility: Texas Cancer Center - Sherman
state: Texas
city: Waco
country: United States
facility: Texas Oncology Cancer Care And Research Center
state: Texas
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists
state: Utah
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
city: Charlottesville
country: United States
facility: University Of Virginia Health System.
state: Virginia
city: Winchester
country: United States
facility: Shenandoah Oncology
state: Virginia
city: Calgary
country: Canada
facility: Local Institution
state: Alberta
city: Halifax
country: Canada
facility: Local Institution
state: Nova Scotia
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: Ottawa
country: Canada
facility: Local Institution
state: Ontario
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Levis
country: Canada
facility: Local Institution
state: Quebec
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Spigel DR, McCleod M, Jotte RM, Einhorn L, Horn L, Waterhouse DM, Creelan B, Babu S, Leighl NB, Chandler JC, Couture F, Keogh G, Goss G, Daniel DB, Garon EB, Schwartzberg LS, Sen R, Korytowsky B, Li A, Aanur N, Hussein MA. Safety, Efficacy, and Patient-Reported Health-Related Quality of Life and Symptom Burden with Nivolumab in Patients with Advanced Non-Small Cell Lung Cancer, Including Patients Aged 70 Years or Older or with Poor Performance Status (CheckMate 153). J Thorac Oncol. 2019 Sep;14(9):1628-1639. doi: 10.1016/j.jtho.2019.05.010. Epub 2019 May 20.