Clincosm LogoSign in Get a demo

CheckMate153: 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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT02066636
Collaborator
(none)
1,434
Enrollment
134
Locations
2
Arms
89.9
Actual Duration (Months)
10.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
1434 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Apr 9, 2014
Actual Primary Completion Date :
Oct 6, 2021
Actual Study Completion Date :
Oct 6, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort A: Nivolumab

Nivolumab 3 mg/kg solution intravenous infusion over 60 minutes every two weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent

Drug: Nivolumab
Other Names:
  • BMS-936558

    		•
    Experimental: Cohort B: Nivolumab

    Nivolumab 3 mg/kg solution intravenous infusion over 60 minutes every two weeks until 1 year (52 weeks). Discontinue treatment and at progression, retreatment allowed

    Drug: Nivolumab
    Other Names:
  • BMS-936558

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence for high grade (Grade 3-4 and Grade 5) treatment related select adverse events (AEs) [Up to 100 days after last dose date (approximately up to 6.5 years)]

    Secondary Outcome Measures

    1. Incidence for high grade (Grade 3-4 and Grade 5) select AEs [Up to 100 days after last dose date (approximately up to 6.5 years)]

    2. Median time to onset and median time to resolution (Grade 3-4) [Up to 100 days after last dose date (approximately up to 6.5 years)]

    3. Percentage of subjects who received immune modulating medication or hormonal replacement therapy, percentage of subjects who received ≥40 mg Prednisone equivalents, total duration of all immune modulating medications given for select event [Up to 100 days after last dose date (approximately up to 6.5 years)]

      Immune modulating medication (e.g. corticosteroids, Infliximab, Cyclophosphamide, intravenous immune globulin (IVIG), and Mycophenolate Mofetil)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    1. 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

    1. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Southern Cancer Center Pc Mobile Alabama United States 36608
    2 Cancer Center Treatment Center of America Goodyear Arizona United States 85338
    3 Arizona Oncology Associates Phoenix Arizona United States 85016
    4 Arizona Oncology Associates Sedona Arizona United States 86336
    5 Arizona Oncol Assoc Dba (Hem Onc Physicians&Extenders) Hope Tucson Arizona United States 85704
    6 Comprehensive Blood And Cancer Center Bakersfield California United States 93309
    7 Diablo Valley Oncology Concord California United States 94520-2054
    8 Saint Jude Heritage Medical Group Virginia K Crosson Cancer Center Fullerton California United States 92835
    9 Ucla Hema/Onc-Santa Monica Los Angeles California United States 90095
    10 Pacific Cancer Care Monterey California United States 93940
    11 Sutter Cancer Center Sacramento California United States 95816
    12 Local Institution San Francisco California United States 94117
    13 Central Coast Med Oncology San Luis Obispo California United States 93401
    14 Sansum Santa Barbara Medical Foundation Clinic Santa Barbara California United States 93105
    15 Central Coast Med Oncology Santa Maria California United States 93454
    16 Torrance Memorial Medical Center Torrance California United States 90505
    17 Rocky Mountain Cancer Centers Denver Colorado United States 80218
    18 Mountain Blue Cancer Care Center Golden Colorado United States 80401
    19 St. Mary's Hospital Regional Cancer Center Grand Junction Colorado United States 81501
    20 Eastern Ct Hem Onc Assoc Norwich Connecticut United States 06360
    21 Holy Cross Hospital Inc. Fort Lauderdale Florida United States 33308-4603
    22 Florida Cancer Specialists S. Fort Myers Florida United States 33901
    23 Baptist Cancer Institute Jacksonville Florida United States 32207
    24 Watson Clinic Center For Research,Inc Lakeland Florida United States 33805
    25 Baptist Health Medical Group Oncology Miami Florida United States 33176
    26 Ocala Oncology Center Ocala Florida United States 34474
    27 Cancer Institute Of Florida Orlando Florida United States 32804
    28 Memorial Cancer Institute Pemroke Pines Florida United States 33028
    29 Sacred Heart Medical Oncology Group Pensacola Florida United States 32504
    30 Hematology/Oncology Associates Of The Treasure Coast Port Saint Lucie Florida United States 34952
    31 Florida Cancer Specialists Saint Petersburg Florida United States 33705
    32 H. Lee Moffitt Cancer Center Tampa Florida United States 33612
    33 Space Coast Cancer Center Titusville Florida United States 32796
    34 University Cancer Blood Ctr Athens Georgia United States 30607
    35 Piedmont Hospital Atlanta Georgia United States 30318
    36 Central Georgia Cancer Care, Pc Macon Georgia United States 31201
    37 Cancer Treatment Centers Of America Newnan Georgia United States 30265
    38 Summit Cancer Care Savannah Georgia United States 31405
    39 Lewis Hall Singletary Oncology Center Thomasville Georgia United States 31792
    40 Pearlman Cancer Center Valdosta Georgia United States 31602
    41 University Of Illinois Cancer Center Chicago Illinois United States 60612
    42 Illinois Cancer Specialists Niles Illinois United States 60714
    43 Oncology Specialists Park Ridge Illinois United States 60068
    44 Quincy Medical Group Quincy Illinois United States 62301
    45 Orchard Healthcare Research Inc. Skokie Illinois United States 60077
    46 Southern Illinois University School Of Medicine Springfield Illinois United States 62794-9678
    47 Ft. Wayne Med Onco-Hema Inc Fort Wayne Indiana United States 46804
    48 Indiana University Health Melvin And Bren Simon Cancer Center Indianapolis Indiana United States 46202
    49 Cancer Center Of Kansas Wichita Kansas United States 67214
    50 James Graham Brown Cancer Center Louisville Kentucky United States 40202
    51 Norton Cancer Center Louisville Kentucky United States 40202
    52 West KY Hematology Oncology Group PSC Paducah Kentucky United States 42003
    53 Christus Schumpert Health Shreveport Louisiana United States 71105
    54 Local Institution Brewer Maine United States 04412
    55 Anne Arundel Medical Center Annapolis Maryland United States 21401
    56 Greater Baltimore Medical Center Baltimore Maryland United States 21204
    57 Walter Reed National Mltry Medical Center Bethesda Maryland United States 20889
    58 Maryland Oncology Hematology, P.A. Columbia Maryland United States 21044
    59 Bay Hematology Oncology Easton Maryland United States 21601
    60 Michigan Cancer Research Consortinum Ann Arbor Michigan United States 48016
    61 Cancer & Hematology Centers Of Western Michigan Grand Rapids Michigan United States 49503
    62 Providence Cancer Center Southfield Michigan United States 48075
    63 Forrest General Cancer Center Hattiesburg Mississippi United States 39401
    64 Jackson Oncology Associates, Pllc Jackson Mississippi United States 39202
    65 North Mississippi Hematology And Oncology Associates, Ltd Tupelo Mississippi United States 38801
    66 University Of Kansas Cancer Center North Kansas City Missouri United States 64116
    67 Mercy Medical Research Institute Springfield Missouri United States 65807
    68 Southeast Nebraska Hematology & Oncology Consultants, P.C. Lincoln Nebraska United States 68510
    69 Nebraska Cancer Specialists Omaha Nebraska United States 68130
    70 Comprehensive Cancer Center Of Nevada Las Vegas Nevada United States 89119
    71 VA Sierra Nevada Health Care System Reno Nevada United States 89502
    72 Hunterdon Medical Center Flemington New Jersey United States 08822
    73 Atlantic Health System Summit New Jersey United States 07091
    74 Presbyterian Medical Group Albuquerque New Mexico United States 87110
    75 St. Peters Hospital Albany New York United States 12208
    76 Maimonides Medical Center Brooklyn New York United States 11220
    77 Queens Medical Associates Fresh Meadows New York United States 11366
    78 Broome Oncology Johnson City New York United States 13790
    79 Winthrop University Hospital Mineola New York United States 11501
    80 Mount Kisco Medical Group Mount Kisco New York United States 10549
    81 Columbia University Medical Center (Cumc) New York New York United States 10032
    82 Hematology-Oncology Associates Of Rockland Nyack New York United States 10960
    83 Randolph Cancer Center Asheboro North Carolina United States 27203
    84 Southeastern Medical Oncology Center Goldsboro North Carolina United States 27534
    85 Moses Cone Regional Cancer Center Greensboro North Carolina United States 27403
    86 East Carolina University Leo W. Jenkins Cancer Center Greeville North Carolina United States 27834
    87 W.G. Bill Hefner VA Medical Center Salisbury North Carolina United States 28144
    88 Mid Dakota Clinic, Pc Bismarck North Dakota United States 58501
    89 Oncology Hematology Care, Incorporated Cincinnati Ohio United States 45242
    90 Local Institution Cleveland Ohio United States 44195
    91 Zangmeister Cancer Center Columbus Ohio United States 43219
    92 Lehigh Valley Hospital Allentown Pennsylvania United States 18103
    93 St. Luke's University Hospital Bethlehem Bethlehem Pennsylvania United States 18015
    94 Lancaster General Hospital Lancaster Pennsylvania United States 17604
    95 St. Mary Medical Center Langhorne Pennsylvania United States 19047
    96 Allegheny General Hospital Pittsburgh Pennsylvania United States 15212
    97 Charleston Hematology Oncology Associates, Pa Charleston South Carolina United States 29414
    98 South Carolina Oncology Associates Columbia South Carolina United States 29210
    99 Greenville Health System Greenville South Carolina United States 29605
    100 Tennessee Oncology, PLLC - SCRI - PPDS Chattanooga Tennessee United States 37404
    101 Cancer Care Of Wnc Germantown Tennessee United States 38138
    102 The Jones Clinic, PC Germantown Tennessee United States 38138
    103 The West Clinic, P.C. Germantown Tennessee United States 38138
    104 Tennessee Oncology, Pllc Nashville Tennessee United States 37203
    105 Henry-Joyce Cancer Center Nashville Tennessee United States 37232-0021
    106 Texas Oncology-Abilene Abilene Texas United States 79606
    107 Texas Oncology - Amarillo Amarillo Texas United States 79106
    108 Texas Oncology Arlington Texas United States 76012
    109 Texas Oncology-Beaumont Beaumont Texas United States 77702
    110 Texas Oncology Bedford Texas United States 76022
    111 Texas Oncology Dallas Texas United States 75230
    112 Texas Oncology Dallas Texas United States 75231
    113 Charles A. Sammons Cancer Center Dallas Texas United States 75246
    114 Texas Oncology Denton Texas United States 76201
    115 The Center For Cancer And Blood Disorders Fort Worth Texas United States 76104
    116 Northwest Cancer Center Houston Texas United States 77090
    117 Texas Oncology McAllen Texas United States 78503
    118 Texas Oncology Mesquite Texas United States 75150
    119 Texas Oncology - Odessa Midland Texas United States 79701
    120 Texas Oncology-Plano East Plano Texas United States 75075
    121 Cancer Care Centers Of South Texas San Antonio Texas United States 78212
    122 Texas Cancer Center - Sherman Sherman Texas United States 75090
    123 Texas Oncology Cancer Care And Research Center Waco Texas United States 76712
    124 Utah Cancer Specialists Salt Lake City Utah United States 84106
    125 Huntsman Cancer Institute Salt Lake City Utah United States 84112
    126 University Of Virginia Health System. Charlottesville Virginia United States 22908
    127 Shenandoah Oncology Winchester Virginia United States 22601
    128 Local Institution Calgary Alberta Canada T2N 4N2
    129 Local Institution Halifax Nova Scotia Canada B3H 2Y9
    130 Kingston General Hospital Kingston Ontario Canada K7L 2V7
    131 Local Institution Ottawa Ontario Canada K1H 8L6
    132 Local Institution Toronto Ontario Canada M5G 2M9
    133 Local Institution Levis Quebec Canada G6V 3Z1
    134 Local Institution Montreal Quebec Canada H3T 1E2

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT02066636
    Other Study ID Numbers:
    • CA209-153
    First Posted:
    Feb 19, 2014
    Last Update Posted:
    Feb 9, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Nivolumab

    Study Results

    No Results Posted as of Feb 9, 2022