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

Non Small Cell Lung Cancer (NSCLC) Clinical Trial

— CheckMate153  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02066636
• Other study ID #: CA209-153
• Status: Completed
• Phase: Phase 3
• Start date: April 9, 2014
• Est. completion date: October 6, 2021

Study information

• Verified date: September 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1428
• Est. completion date: October 6, 2021
• Est. primary completion date: October 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer (NSCLC)

Intervention

Drug:
• Nivolumab

Locations

Country	Name	City	State
Canada	Local Institution	Calgary	Alberta
Canada	Local Institution	Halifax	Nova Scotia
Canada	Kingston General Hospital	Kingston	Ontario
Canada	Local Institution	Levis	Quebec
Canada	Local Institution	Montreal	Quebec
Canada	Local Institution	Ottawa	Ontario
Canada	Local Institution	Toronto	Ontario
United States	Texas Oncology-Abilene	Abilene	Texas
United States	St. Peters Hospital	Albany	New York
United States	Presbyterian Medical Group	Albuquerque	New Mexico
United States	Lehigh Valley Hospital	Allentown	Pennsylvania
United States	Texas Oncology - Amarillo	Amarillo	Texas
United States	Michigan Cancer Research Consortinum	Ann Arbor	Michigan
United States	Anne Arundel Medical Center	Annapolis	Maryland
United States	Texas Oncology	Arlington	Texas
United States	Randolph Cancer Center	Asheboro	North Carolina
United States	University Cancer Blood Ctr	Athens	Georgia
United States	Piedmont Hospital	Atlanta	Georgia
United States	Comprehensive Blood And Cancer Center	Bakersfield	California
United States	Greater Baltimore Medical Center	Baltimore	Maryland
United States	Texas Oncology-Beaumont	Beaumont	Texas
United States	Texas Oncology	Bedford	Texas
United States	Walter Reed National Mltry Medical Center	Bethesda	Maryland
United States	St. Luke's University Hospital Bethlehem	Bethlehem	Pennsylvania
United States	Mid Dakota Clinic, Pc	Bismarck	North Dakota
United States	Local Institution	Brewer	Maine
United States	Maimonides Medical Center	Brooklyn	New York
United States	Charleston Hematology Oncology Associates, Pa	Charleston	South Carolina
United States	University Of Virginia Health System.	Charlottesville	Virginia
United States	Tennessee Oncology, PLLC - SCRI - PPDS	Chattanooga	Tennessee
United States	University Of Illinois Cancer Center	Chicago	Illinois
United States	Oncology Hematology Care, Incorporated	Cincinnati	Ohio
United States	Local Institution	Cleveland	Ohio
United States	Maryland Oncology Hematology, P.A.	Columbia	Maryland
United States	South Carolina Oncology Associates	Columbia	South Carolina
United States	Zangmeister Cancer Center	Columbus	Ohio
United States	Diablo Valley Oncology	Concord	California
United States	Local Institution - 0067	Dallas	Texas
United States	Texas Oncology	Dallas	Texas
United States	Texas Oncology	Dallas	Texas
United States	Texas Oncology	Denton	Texas
United States	Rocky Mountain Cancer Centers	Denver	Colorado
United States	Bay Hematology Oncology	Easton	Maryland
United States	Hunterdon Medical Center	Flemington	New Jersey
United States	Holy Cross Hospital Inc.	Fort Lauderdale	Florida
United States	Florida Cancer Specialists S.	Fort Myers	Florida
United States	Local Institution - 0081	Fort Wayne	Indiana
United States	The Center For Cancer And Blood Disorders	Fort Worth	Texas
United States	Queens Medical Associates	Fresh Meadows	New York
United States	Saint Jude Heritage Medical Group Virginia K Crosson Cancer Center	Fullerton	California
United States	Cancer Care Of Wnc	Germantown	Tennessee
United States	The Jones Clinic, PC	Germantown	Tennessee
United States	The West Clinic, P.C.	Germantown	Tennessee
United States	Mountain Blue Cancer Care Center	Golden	Colorado
United States	Southeastern Medical Oncology Center	Goldsboro	North Carolina
United States	Cancer Center Treatment Center of America	Goodyear	Arizona
United States	St. Mary's Hospital Regional Cancer Center	Grand Junction	Colorado
United States	Cancer & Hematology Centers Of Western Michigan	Grand Rapids	Michigan
United States	Moses Cone Regional Cancer Center	Greensboro	North Carolina
United States	Greenville Health System	Greenville	South Carolina
United States	East Carolina University Leo W. Jenkins Cancer Center	Greeville	North Carolina
United States	Forrest General Cancer Center	Hattiesburg	Mississippi
United States	Northwest Cancer Center	Houston	Texas
United States	Indiana University Health Melvin And Bren Simon Cancer Center	Indianapolis	Indiana
United States	Jackson Oncology Associates, Pllc	Jackson	Mississippi
United States	Baptist Cancer Institute	Jacksonville	Florida
United States	Broome Oncology	Johnson City	New York
United States	Local Institution - 0031	Lakeland	Florida
United States	Lancaster General Hospital	Lancaster	Pennsylvania
United States	St. Mary Medical Center	Langhorne	Pennsylvania
United States	Comprehensive Cancer Center Of Nevada	Las Vegas	Nevada
United States	Southeast Nebraska Hematology & Oncology Consultants, P.C.	Lincoln	Nebraska
United States	Ucla Hema/Onc-Santa Monica	Los Angeles	California
United States	Norton Cancer Center	Louisville	Kentucky
United States	University Medical Center, Inc	Louisville	Kentucky
United States	Central Georgia Cancer Care, Pc	Macon	Georgia
United States	Texas Oncology	McAllen	Texas
United States	Texas Oncology	Mesquite	Texas
United States	Local Institution - 0038	Miami	Florida
United States	Texas Oncology - Odessa	Midland	Texas
United States	Winthrop University Hospital	Mineola	New York
United States	Southern Cancer Center Pc	Mobile	Alabama
United States	Pacific Cancer Care	Monterey	California
United States	Mount Kisco Medical Group	Mount Kisco	New York
United States	Henry-Joyce Cancer Center	Nashville	Tennessee
United States	Tennessee Oncology, Pllc	Nashville	Tennessee
United States	Columbia University Medical Center (Cumc)	New York	New York
United States	Cancer Treatment Centers Of America	Newnan	Georgia
United States	Illinois Cancer Specialists	Niles	Illinois
United States	University Of Kansas Cancer Center	North Kansas City	Missouri
United States	Eastern Ct Hem Onc Assoc	Norwich	Connecticut
United States	Hematology-Oncology Associates Of Rockland	Nyack	New York
United States	Ocala Oncology Center	Ocala	Florida
United States	Nebraska Cancer Specialists	Omaha	Nebraska
United States	Cancer Institute Of Florida	Orlando	Florida
United States	West KY Hematology Oncology Group PSC	Paducah	Kentucky
United States	Oncology Specialists	Park Ridge	Illinois
United States	Memorial Cancer Institute	Pemroke Pines	Florida
United States	Local Institution - 0071	Pensacola	Florida
United States	Arizona Oncology Associates	Phoenix	Arizona
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Texas Oncology-Plano East	Plano	Texas
United States	Hematology/Oncology Associates Of The Treasure Coast	Port Saint Lucie	Florida
United States	Quincy Medical Group	Quincy	Illinois
United States	VA Sierra Nevada Health Care System	Reno	Nevada
United States	Sutter Cancer Center	Sacramento	California
United States	Florida Cancer Specialists	Saint Petersburg	Florida
United States	W.G. Bill Hefner VA Medical Center	Salisbury	North Carolina
United States	Huntsman Cancer Institute	Salt Lake City	Utah
United States	Utah Cancer Specialists	Salt Lake City	Utah
United States	Cancer Care Centers Of South Texas	San Antonio	Texas
United States	Local Institution	San Francisco	California
United States	Central Coast Med Oncology	San Luis Obispo	California
United States	Sansum Santa Barbara Medical Foundation Clinic	Santa Barbara	California
United States	Central Coast Med Oncology	Santa Maria	California
United States	Summit Cancer Care	Savannah	Georgia
United States	Arizona Oncology Associates	Sedona	Arizona
United States	Texas Cancer Center - Sherman	Sherman	Texas
United States	Christus Schumpert Health	Shreveport	Louisiana
United States	Local Institution - 0015	Skokie	Illinois
United States	Providence Cancer Center	Southfield	Michigan
United States	Mercy Medical Research Institute	Springfield	Missouri
United States	Southern Illinois University School Of Medicine	Springfield	Illinois
United States	Atlantic Health System	Summit	New Jersey
United States	Local Institution - 0108	Tampa	Florida
United States	Lewis Hall Singletary Oncology Center	Thomasville	Georgia
United States	Space Coast Cancer Center	Titusville	Florida
United States	Torrance Memorial Medical Center	Torrance	California
United States	Arizona Oncol Assoc Dba (Hem Onc Physicians&Extenders) Hope	Tucson	Arizona
United States	North Mississippi Hematology And Oncology Associates, Ltd	Tupelo	Mississippi
United States	Pearlman Cancer Center	Valdosta	Georgia
United States	Texas Oncology Cancer Care And Research Center	Waco	Texas
United States	Cancer Center Of Kansas	Wichita	Kansas
United States	Shenandoah Oncology	Winchester	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Median Time to Onset of Select Adverse Events (Grade 3-5)	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.	From first dose and 100 days after last dose (last dose up to randomization for cohort B) (up to approximately 88 months)
Secondary	Median Time to Resolution of Select Adverse Events (Grade 3-5)	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.	From first dose and 100 days after last dose (last dose up to randomization for cohort B) (up to approximately 88 months)
Secondary	The Number of Participants Who Received Immune Modulating Medication (or Hormonal Replacement Therapy) for Any Grade Select Adverse Events	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.	From first dose and 100 days after last dose (last dose up to randomization for cohort B) (up to approximately 88 months)
Secondary	The Number of Participants Who Received = 40 mg Prednisone Equivalents for Any Grade Select Adverse Events	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.	From first dose and 100 days after last dose (last dose up to randomization for cohort B) (up to approximately 88 months)
Secondary	The Total Duration of All Immune Modulating Medications for Any Grade Select Adverse Events	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.	From first dose first dose and 100 days after last dose (last dose up to randomization for cohort B) (up to approximately 88 months)
Secondary	The Number of Participants With High Grade (Grade 3-4 and Grade 5) Select Adverse Events	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.	From first dose and 100 days after last dose (last dose up to randomization for cohort B) (up to approximately 88 months)

External Links

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