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
CheckMate153
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
1 other identifier
interventional
1,428
2 countries
134
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2014
Longer than P75 for phase_3
134 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2014
CompletedFirst Posted
Study publicly available on registry
February 19, 2014
CompletedStudy Start
First participant enrolled
April 9, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 6, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 6, 2021
CompletedResults Posted
Study results publicly available
October 27, 2022
CompletedOctober 27, 2022
September 1, 2022
7.5 years
February 14, 2014
September 29, 2022
September 29, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
The Number of Participants With Treatment Related Select Adverse Events (Grade 3-4 and Grade 5)
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.
From first dose and 100 days after last dose (last dose up to randomization for cohort B) (up to approximately 88 months)
Secondary Outcomes (6)
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)
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 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 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 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)
- +1 more secondary outcomes
Study Arms (2)
Cohort A: Nivolumab
EXPERIMENTALNivolumab 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
EXPERIMENTALNivolumab 3 mg/kg solution intravenous infusion over 30 minutes every two weeks until 1 year (52 weeks). Discontinue treatment and at progression, retreatment allowed
Interventions
Eligibility Criteria
You may qualify if:
- \. 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (134)
Southern Cancer Center Pc
Mobile, Alabama, 36608, United States
Cancer Center Treatment Center of America
Goodyear, Arizona, 85338, United States
Arizona Oncology Associates
Phoenix, Arizona, 85016, United States
Arizona Oncology Associates
Sedona, Arizona, 86336, United States
Arizona Oncol Assoc Dba (Hem Onc Physicians&Extenders) Hope
Tucson, Arizona, 85704, United States
Comprehensive Blood And Cancer Center
Bakersfield, California, 93309, United States
Diablo Valley Oncology
Concord, California, 94520-2054, United States
Saint Jude Heritage Medical Group Virginia K Crosson Cancer Center
Fullerton, California, 92835, United States
Ucla Hema/Onc-Santa Monica
Los Angeles, California, 90095, United States
Pacific Cancer Care
Monterey, California, 93940, United States
Sutter Cancer Center
Sacramento, California, 95816, United States
Local Institution
San Francisco, California, 94117, United States
Central Coast Med Oncology
San Luis Obispo, California, 93401, United States
Sansum Santa Barbara Medical Foundation Clinic
Santa Barbara, California, 93105, United States
Central Coast Med Oncology
Santa Maria, California, 93454, United States
Torrance Memorial Medical Center
Torrance, California, 90505, United States
Rocky Mountain Cancer Centers
Denver, Colorado, 80218, United States
Mountain Blue Cancer Care Center
Golden, Colorado, 80401, United States
St. Mary's Hospital Regional Cancer Center
Grand Junction, Colorado, 81501, United States
Eastern Ct Hem Onc Assoc
Norwich, Connecticut, 06360, United States
Holy Cross Hospital Inc.
Fort Lauderdale, Florida, 33308-4603, United States
Florida Cancer Specialists S.
Fort Myers, Florida, 33901, United States
Baptist Cancer Institute
Jacksonville, Florida, 32207, United States
Local Institution - 0031
Lakeland, Florida, 33805, United States
Local Institution - 0038
Miami, Florida, 33176, United States
Ocala Oncology Center
Ocala, Florida, 34474, United States
Cancer Institute Of Florida
Orlando, Florida, 32804, United States
Memorial Cancer Institute
Pemroke Pines, Florida, 33028, United States
Local Institution - 0071
Pensacola, Florida, 32504, United States
Hematology/Oncology Associates Of The Treasure Coast
Port Saint Lucie, Florida, 34952, United States
Florida Cancer Specialists
St. Petersburg, Florida, 33705, United States
Local Institution - 0108
Tampa, Florida, 33612, United States
Space Coast Cancer Center
Titusville, Florida, 32796, United States
University Cancer Blood Ctr
Athens, Georgia, 30607, United States
Piedmont Hospital
Atlanta, Georgia, 30318, United States
Central Georgia Cancer Care, Pc
Macon, Georgia, 31201, United States
Cancer Treatment Centers Of America
Newnan, Georgia, 30265, United States
Summit Cancer Care
Savannah, Georgia, 31405, United States
Lewis Hall Singletary Oncology Center
Thomasville, Georgia, 31792, United States
Pearlman Cancer Center
Valdosta, Georgia, 31602, United States
University Of Illinois Cancer Center
Chicago, Illinois, 60612, United States
Illinois Cancer Specialists
Niles, Illinois, 60714, United States
Oncology Specialists
Park Ridge, Illinois, 60068, United States
Quincy Medical Group
Quincy, Illinois, 62301, United States
Local Institution - 0015
Skokie, Illinois, 60077, United States
Southern Illinois University School Of Medicine
Springfield, Illinois, 62794-9678, United States
Local Institution - 0081
Fort Wayne, Indiana, 46804, United States
Indiana University Health Melvin And Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Cancer Center Of Kansas
Wichita, Kansas, 67214, United States
Norton Cancer Center
Louisville, Kentucky, 40202, United States
University Medical Center, Inc
Louisville, Kentucky, 40202, United States
West KY Hematology Oncology Group PSC
Paducah, Kentucky, 42003, United States
Christus Schumpert Health
Shreveport, Louisiana, 71105, United States
Local Institution
Brewer, Maine, 04412, United States
Anne Arundel Medical Center
Annapolis, Maryland, 21401, United States
Greater Baltimore Medical Center
Baltimore, Maryland, 21204, United States
Walter Reed National Mltry Medical Center
Bethesda, Maryland, 20889, United States
Maryland Oncology Hematology, P.A.
Columbia, Maryland, 21044, United States
Bay Hematology Oncology
Easton, Maryland, 21601, United States
Michigan Cancer Research Consortinum
Ann Arbor, Michigan, 48016, United States
Cancer & Hematology Centers Of Western Michigan
Grand Rapids, Michigan, 49503, United States
Providence Cancer Center
Southfield, Michigan, 48075, United States
Forrest General Cancer Center
Hattiesburg, Mississippi, 39401, United States
Jackson Oncology Associates, Pllc
Jackson, Mississippi, 39202, United States
North Mississippi Hematology And Oncology Associates, Ltd
Tupelo, Mississippi, 38801, United States
University Of Kansas Cancer Center
North Kansas City, Missouri, 64116, United States
Mercy Medical Research Institute
Springfield, Missouri, 65807, United States
Southeast Nebraska Hematology & Oncology Consultants, P.C.
Lincoln, Nebraska, 68510, United States
Nebraska Cancer Specialists
Omaha, Nebraska, 68130, United States
Comprehensive Cancer Center Of Nevada
Las Vegas, Nevada, 89119, United States
VA Sierra Nevada Health Care System
Reno, Nevada, 89502, United States
Hunterdon Medical Center
Flemington, New Jersey, 08822, United States
Atlantic Health System
Summit, New Jersey, 07091, United States
Presbyterian Medical Group
Albuquerque, New Mexico, 87110, United States
St. Peters Hospital
Albany, New York, 12208, United States
Maimonides Medical Center
Brooklyn, New York, 11220, United States
Queens Medical Associates
Fresh Meadows, New York, 11366, United States
Broome Oncology
Johnson City, New York, 13790, United States
Winthrop University Hospital
Mineola, New York, 11501, United States
Mount Kisco Medical Group
Mount Kisco, New York, 10549, United States
Columbia University Medical Center (Cumc)
New York, New York, 10032, United States
Hematology-Oncology Associates Of Rockland
Nyack, New York, 10960, United States
Randolph Cancer Center
Asheboro, North Carolina, 27203, United States
Southeastern Medical Oncology Center
Goldsboro, North Carolina, 27534, United States
Moses Cone Regional Cancer Center
Greensboro, North Carolina, 27403, United States
East Carolina University Leo W. Jenkins Cancer Center
Greeville, North Carolina, 27834, United States
W.G. Bill Hefner VA Medical Center
Salisbury, North Carolina, 28144, United States
Mid Dakota Clinic, Pc
Bismarck, North Dakota, 58501, United States
Oncology Hematology Care, Incorporated
Cincinnati, Ohio, 45242, United States
Local Institution
Cleveland, Ohio, 44195, United States
Zangmeister Cancer Center
Columbus, Ohio, 43219, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103, United States
St. Luke's University Hospital Bethlehem
Bethlehem, Pennsylvania, 18015, United States
Lancaster General Hospital
Lancaster, Pennsylvania, 17604, United States
St. Mary Medical Center
Langhorne, Pennsylvania, 19047, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
Charleston Hematology Oncology Associates, Pa
Charleston, South Carolina, 29414, United States
South Carolina Oncology Associates
Columbia, South Carolina, 29210, United States
Greenville Health System
Greenville, South Carolina, 29605, United States
Tennessee Oncology, PLLC - SCRI - PPDS
Chattanooga, Tennessee, 37404, United States
Cancer Care Of Wnc
Germantown, Tennessee, 38138, United States
The Jones Clinic, PC
Germantown, Tennessee, 38138, United States
The West Clinic, P.C.
Germantown, Tennessee, 38138, United States
Tennessee Oncology, Pllc
Nashville, Tennessee, 37203, United States
Henry-Joyce Cancer Center
Nashville, Tennessee, 37232-0021, United States
Texas Oncology-Abilene
Abilene, Texas, 79606, United States
Texas Oncology - Amarillo
Amarillo, Texas, 79106, United States
Texas Oncology
Arlington, Texas, 76012, United States
Texas Oncology-Beaumont
Beaumont, Texas, 77702, United States
Texas Oncology
Bedford, Texas, 76022, United States
Texas Oncology
Dallas, Texas, 75230, United States
Texas Oncology
Dallas, Texas, 75231, United States
Local Institution - 0067
Dallas, Texas, 75246, United States
Texas Oncology
Denton, Texas, 76201, United States
The Center For Cancer And Blood Disorders
Fort Worth, Texas, 76104, United States
Northwest Cancer Center
Houston, Texas, 77090, United States
Texas Oncology
McAllen, Texas, 78503, United States
Texas Oncology
Mesquite, Texas, 75150, United States
Texas Oncology - Odessa
Midland, Texas, 79701, United States
Texas Oncology-Plano East
Plano, Texas, 75075, United States
Cancer Care Centers Of South Texas
San Antonio, Texas, 78212, United States
Texas Cancer Center - Sherman
Sherman, Texas, 75090, United States
Texas Oncology Cancer Care And Research Center
Waco, Texas, 76712, United States
Utah Cancer Specialists
Salt Lake City, Utah, 84106, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
University Of Virginia Health System.
Charlottesville, Virginia, 22908, United States
Shenandoah Oncology
Winchester, Virginia, 22601, United States
Local Institution
Calgary, Alberta, T2N 4N2, Canada
Local Institution
Halifax, Nova Scotia, B3H 2Y9, Canada
Kingston General Hospital
Kingston, Ontario, K7L 2V7, Canada
Local Institution
Ottawa, Ontario, K1H 8L6, Canada
Local Institution
Toronto, Ontario, M5G 2M9, Canada
Local Institution
Lévis, Quebec, G6V 3Z1, Canada
Local Institution
Montreal, Quebec, H3T 1E2, Canada
Related Publications (1)
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.
PMID: 31121324DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
February 14, 2014
First Posted
February 19, 2014
Study Start
April 9, 2014
Primary Completion
October 6, 2021
Study Completion
October 6, 2021
Last Updated
October 27, 2022
Results First Posted
October 27, 2022
Record last verified: 2022-09