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
- Registration Number
- NCT02066636
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1428
- 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
-
Target Disease Exceptions
- Subjects with active central nervous system (CNS) metastases are excluded
- Subjects with carcinomatous meningitis
-
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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort A: Nivolumab Nivolumab Nivolumab 3 mg/kg solution intravenous infusion over 30 minutes every two weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent Cohort B: Nivolumab Nivolumab Nivolumab 3 mg/kg solution intravenous infusion over 30 minutes every two weeks until 1 year (52 weeks). Discontinue treatment and at progression, retreatment allowed
- Primary Outcome Measures
Name Time Method The Number of Participants With Treatment Related Select Adverse Events (Grade 3-4 and Grade 5) From first dose and 100 days after last dose (last dose up to randomization for cohort B) (up to approximately 88 months) A treatment related adverse event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered an investigational (medicinal) product and that has a causal relationship with this treatment. The select AEs categories are those that are expected to be most commonly used to describe pneumonitis, interstitial nephritis, diarrhea/colitis, hepatitis, rash, and endocrinopathies and hypersensitivity/infusion reactions. AEs are graded according to NCI CTCAE (Version 4.0) guidelines where Grade 3= Severe, Grade 4 = Life-threatening, Grade 5 = Death.
- Secondary Outcome Measures
Name Time Method Median Time to Onset of Select Adverse Events (Grade 3-5) From first dose and 100 days after last dose (last dose up to randomization for cohort B) (up to approximately 88 months) The time from first dose to the first occurrence of any select adverse event of interest. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. The select AEs categories are those that are expected to be most commonly used to describe pneumonitis, interstitial nephritis, diarrhea/colitis, hepatitis, rash, and endocrinopathies and hypersensitivity/infusion reactions. AEs are graded according to NCI CTCAE (Version 4.0) guidelines where Grade 3= Severe, Grade 4 = Life-threatening, Grade 5 = Death.
The Total Duration of All Immune Modulating Medications for Any Grade Select Adverse Events From first dose first dose and 100 days after last dose (last dose up to randomization for cohort B) (up to approximately 88 months) The duration of time participants received medication meant to trigger an immune response for any select Adverse events of interest. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. The select AEs categories are those that are expected to be most commonly used to describe pneumonitis, interstitial nephritis, diarrhea/colitis, hepatitis, rash, and endocrinopathies and hypersensitivity/infusion reactions. AEs are graded according to NCI CTCAE (Version 4.0) guidelines where Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4 = Life-threatening, Grade 5 = Death.
Median Time to Resolution of Select Adverse Events (Grade 3-5) From first dose and 100 days after last dose (last dose up to randomization for cohort B) (up to approximately 88 months) The time from the onset of any select adverse event of interest to its resolution or stabilization. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. The select AEs categories are those that are expected to be most commonly used to describe pneumonitis, interstitial nephritis, diarrhea/colitis, hepatitis, rash, and endocrinopathies and hypersensitivity/infusion reactions. AEs are graded according to NCI CTCAE (Version 4.0) guidelines where Grade 3= Severe, Grade 4 = Life-threatening, Grade 5 = Death.
The Number of Participants Who Received Immune Modulating Medication (or Hormonal Replacement Therapy) for Any Grade Select Adverse Events From first dose and 100 days after last dose (last dose up to randomization for cohort B) (up to approximately 88 months) The number of participants receiving medication meant to trigger an immune response for any select Adverse events of interest. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. The select AEs categories are those that are expected to be most commonly used to describe pneumonitis, interstitial nephritis, diarrhea/colitis, hepatitis, rash, and endocrinopathies and hypersensitivity/infusion reactions. AEs are graded according to NCI CTCAE (Version 4.0) guidelines where Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4 = Life-threatening, Grade 5 = Death.
The Number of Participants Who Received ≥ 40 mg Prednisone Equivalents for Any Grade Select Adverse Events From first dose and 100 days after last dose (last dose up to randomization for cohort B) (up to approximately 88 months) The number of participants receiving \> 40mg prednisone equivalents for any select adverse event of interest. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. The select AEs categories are those that are expected to be most commonly used to describe pneumonitis, interstitial nephritis, diarrhea/colitis, hepatitis, rash, and endocrinopathies and hypersensitivity/infusion reactions. AEs are graded according to NCI CTCAE (Version 4.0) guidelines where Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4 = Life-threatening, Grade 5 = Death.
The Number of Participants With High Grade (Grade 3-4 and Grade 5) Select Adverse Events From first dose and 100 days after last dose (last dose up to randomization for cohort B) (up to approximately 88 months) An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. The select AEs categories are those that are expected to be most commonly used to describe pneumonitis, interstitial nephritis, diarrhea/colitis, hepatitis, rash, and endocrinopathies and hypersensitivity/infusion reactions. AEs are graded according to NCI CTCAE (Version 4.0) guidelines where Grade 3= Severe, Grade 4 = Life-threatening, Grade 5 = Death.
Trial Locations
- Locations (118)
Comprehensive Blood And Cancer Center
🇺🇸Bakersfield, California, United States
Ucla Hema/Onc-Santa Monica
🇺🇸Los Angeles, California, United States
Central Georgia Cancer Care, Pc
🇺🇸Macon, Georgia, United States
Local Institution - 0015
🇺🇸Skokie, Illinois, United States
West KY Hematology Oncology Group PSC
🇺🇸Paducah, Kentucky, United States
Maryland Oncology Hematology, P.A.
🇺🇸Columbia, Maryland, United States
North Mississippi Hematology And Oncology Associates, Ltd
🇺🇸Tupelo, Mississippi, United States
Moses Cone Regional Cancer Center
🇺🇸Greensboro, North Carolina, United States
Mid Dakota Clinic, Pc
🇺🇸Bismarck, North Dakota, United States
University Of Illinois Cancer Center
🇺🇸Chicago, Illinois, United States
Zangmeister Cancer Center
🇺🇸Columbus, Ohio, United States
Lancaster General Hospital
🇺🇸Lancaster, Pennsylvania, United States
Indiana University Health Melvin And Bren Simon Cancer Center
🇺🇸Indianapolis, Indiana, United States
Northwest Cancer Center
🇺🇸Houston, Texas, United States
Local Institution - 0038
🇺🇸Miami, Florida, United States
Comprehensive Cancer Center Of Nevada
🇺🇸Las Vegas, Nevada, United States
Oncology Hematology Care, Incorporated
🇺🇸Cincinnati, Ohio, United States
Central Coast Med Oncology
🇺🇸Santa Maria, California, United States
Saint Jude Heritage Medical Group Virginia K Crosson Cancer Center
🇺🇸Fullerton, California, United States
Sutter Cancer Center
🇺🇸Sacramento, California, United States
Diablo Valley Oncology
🇺🇸Concord, California, United States
Piedmont Hospital
🇺🇸Atlanta, Georgia, United States
Providence Cancer Center
🇺🇸Southfield, Michigan, United States
Pacific Cancer Care
🇺🇸Monterey, California, United States
Cancer Center Of Kansas
🇺🇸Wichita, Kansas, United States
Local Institution
🇨🇦Montreal, Quebec, Canada
Cancer Center Treatment Center of America
🇺🇸Goodyear, Arizona, United States
Oncology Specialists
🇺🇸Park Ridge, Illinois, United States
Torrance Memorial Medical Center
🇺🇸Torrance, California, United States
Mountain Blue Cancer Care Center
🇺🇸Golden, Colorado, United States
Southern Cancer Center Pc
🇺🇸Mobile, Alabama, United States
Greater Baltimore Medical Center
🇺🇸Baltimore, Maryland, United States
Jackson Oncology Associates, Pllc
🇺🇸Jackson, Mississippi, United States
Charleston Hematology Oncology Associates, Pa
🇺🇸Charleston, South Carolina, United States
Greenville Health System
🇺🇸Greenville, South Carolina, United States
Local Institution - 0031
🇺🇸Lakeland, Florida, United States
St. Mary Medical Center
🇺🇸Langhorne, Pennsylvania, United States
Holy Cross Hospital Inc.
🇺🇸Fort Lauderdale, Florida, United States
Lehigh Valley Hospital
🇺🇸Allentown, Pennsylvania, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
South Carolina Oncology Associates
🇺🇸Columbia, South Carolina, United States
St. Luke's University Hospital Bethlehem
🇺🇸Bethlehem, Pennsylvania, United States
Texas Oncology - Odessa
🇺🇸Midland, Texas, United States
The West Clinic, P.C.
🇺🇸Germantown, Tennessee, United States
Texas Oncology-Beaumont
🇺🇸Beaumont, Texas, United States
Texas Oncology-Abilene
🇺🇸Abilene, Texas, United States
Tennessee Oncology, PLLC - SCRI - PPDS
🇺🇸Chattanooga, Tennessee, United States
Tennessee Oncology, Pllc
🇺🇸Nashville, Tennessee, United States
Henry-Joyce Cancer Center
🇺🇸Nashville, Tennessee, United States
Cancer Care Centers Of South Texas
🇺🇸San Antonio, Texas, United States
Utah Cancer Specialists
🇺🇸Salt Lake City, Utah, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
Rocky Mountain Cancer Centers
🇺🇸Denver, Colorado, United States
Walter Reed National Mltry Medical Center
🇺🇸Bethesda, Maryland, United States
Nebraska Cancer Specialists
🇺🇸Omaha, Nebraska, United States
Cancer Care Of Wnc
🇺🇸Germantown, Tennessee, United States
Local Institution - 0067
🇺🇸Dallas, Texas, United States
Texas Oncology-Plano East
🇺🇸Plano, Texas, United States
University Of Virginia Health System.
🇺🇸Charlottesville, Virginia, United States
Arizona Oncology Associates
🇺🇸Sedona, Arizona, United States
Arizona Oncol Assoc Dba (Hem Onc Physicians&Extenders) Hope
🇺🇸Tucson, Arizona, United States
Sansum Santa Barbara Medical Foundation Clinic
🇺🇸Santa Barbara, California, United States
St. Mary's Hospital Regional Cancer Center
🇺🇸Grand Junction, Colorado, United States
Eastern Ct Hem Onc Assoc
🇺🇸Norwich, Connecticut, United States
Florida Cancer Specialists S.
🇺🇸Fort Myers, Florida, United States
Baptist Cancer Institute
🇺🇸Jacksonville, Florida, United States
Cancer Institute Of Florida
🇺🇸Orlando, Florida, United States
Ocala Oncology Center
🇺🇸Ocala, Florida, United States
Memorial Cancer Institute
🇺🇸Pemroke Pines, Florida, United States
Local Institution - 0071
🇺🇸Pensacola, Florida, United States
Hematology/Oncology Associates Of The Treasure Coast
🇺🇸Port Saint Lucie, Florida, United States
Florida Cancer Specialists
🇺🇸Saint Petersburg, Florida, United States
Local Institution - 0108
🇺🇸Tampa, Florida, United States
Space Coast Cancer Center
🇺🇸Titusville, Florida, United States
University Cancer Blood Ctr
🇺🇸Athens, Georgia, United States
Cancer Treatment Centers Of America
🇺🇸Newnan, Georgia, United States
Summit Cancer Care
🇺🇸Savannah, Georgia, United States
Lewis Hall Singletary Oncology Center
🇺🇸Thomasville, Georgia, United States
Pearlman Cancer Center
🇺🇸Valdosta, Georgia, United States
Illinois Cancer Specialists
🇺🇸Niles, Illinois, United States
Quincy Medical Group
🇺🇸Quincy, Illinois, United States
Southern Illinois University School Of Medicine
🇺🇸Springfield, Illinois, United States
Local Institution - 0081
🇺🇸Fort Wayne, Indiana, United States
Norton Cancer Center
🇺🇸Louisville, Kentucky, United States
University Medical Center, Inc
🇺🇸Louisville, Kentucky, United States
Christus Schumpert Health
🇺🇸Shreveport, Louisiana, United States
Anne Arundel Medical Center
🇺🇸Annapolis, Maryland, United States
Michigan Cancer Research Consortinum
🇺🇸Ann Arbor, Michigan, United States
Bay Hematology Oncology
🇺🇸Easton, Maryland, United States
Cancer & Hematology Centers Of Western Michigan
🇺🇸Grand Rapids, Michigan, United States
Forrest General Cancer Center
🇺🇸Hattiesburg, Mississippi, United States
University Of Kansas Cancer Center
🇺🇸North Kansas City, Missouri, United States
Mercy Medical Research Institute
🇺🇸Springfield, Missouri, United States
Southeast Nebraska Hematology & Oncology Consultants, P.C.
🇺🇸Lincoln, Nebraska, United States
VA Sierra Nevada Health Care System
🇺🇸Reno, Nevada, United States
Atlantic Health System
🇺🇸Summit, New Jersey, United States
Hunterdon Medical Center
🇺🇸Flemington, New Jersey, United States
Presbyterian Medical Group
🇺🇸Albuquerque, New Mexico, United States
Queens Medical Associates
🇺🇸Fresh Meadows, New York, United States
Maimonides Medical Center
🇺🇸Brooklyn, New York, United States
Mount Kisco Medical Group
🇺🇸Mount Kisco, New York, United States
St. Peters Hospital
🇺🇸Albany, New York, United States
Winthrop University Hospital
🇺🇸Mineola, New York, United States
Broome Oncology
🇺🇸Johnson City, New York, United States
Southeastern Medical Oncology Center
🇺🇸Goldsboro, North Carolina, United States
Columbia University Medical Center (Cumc)
🇺🇸New York, New York, United States
East Carolina University Leo W. Jenkins Cancer Center
🇺🇸Greeville, North Carolina, United States
Hematology-Oncology Associates Of Rockland
🇺🇸Nyack, New York, United States
Randolph Cancer Center
🇺🇸Asheboro, North Carolina, United States
W.G. Bill Hefner VA Medical Center
🇺🇸Salisbury, North Carolina, United States
The Jones Clinic, PC
🇺🇸Germantown, Tennessee, United States
Texas Oncology - Amarillo
🇺🇸Amarillo, Texas, United States
Texas Oncology
🇺🇸Mesquite, Texas, United States
The Center For Cancer And Blood Disorders
🇺🇸Fort Worth, Texas, United States
Texas Oncology Cancer Care And Research Center
🇺🇸Waco, Texas, United States
Texas Cancer Center - Sherman
🇺🇸Sherman, Texas, United States
Shenandoah Oncology
🇺🇸Winchester, Virginia, United States
Kingston General Hospital
🇨🇦Kingston, Ontario, Canada