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RecruitingInterventionalPhase 2

Pan-Tumor Study for Long-term Treatment of Cancer Patients Who Have Participated in BMS Sponsored Trials Investigating Nivolumab and Other Cancer Therapies

NCT ID: NCT03899155Sponsor: Bristol-Myers SquibbLast updated: 2026-06-03

Summary

Main Objective of this study is to examine long-term safety of nivolumab monotherapy including combinations and other cancer therapies in various tumor types.

Arms & interventions

  • DrugNivolumab

    Specified dose on specified days

  • DrugIpilimumab

    Specified dose on specified days

  • DrugCabozantinib

    Specified dose on specified days

  • DrugTrametinib

    Specified dose on specified days

  • DrugRelatlimab

    Specified dose on specified days

  • DrugNivolumab + Relatlimab

    Specified dose on specified days

  • DrugCapecitabine

    Specified dose on specified days

  • DrugBevacizumab

    Specified dose on specified days

  • DrugTemozolomide

    Specified dose on specified days

  • DrugRucaparib

    Specified dose on specified days

  • DrugDaratumumab

    Specified dose on specified days

  • DrugRegorafinib

    Specified dose on specified days

  • DrugLeucovorin

    Specified dose on specified days

  • DrugFluorouracil

    Specified dose on specified days

  • DrugOxaliplatin

    Specified dose on specified days

  • DrugEnzalutamide

    Specified dose on specified days

  • DrugSunitinib

    Specified dose on specified days

  • DrugPemetrexed

    Specified dose on specified days

  • DrugPembrolizumab

    Specified dose on specified days

Outcome measures

Primary

  • Incidence of Adverse Events (AEs)

    Time frame: From Day 1 up to 135 Days after discontinuation of treatment

  • Incidence of drug related AEs

    Time frame: From Day 1 up to 135 Days after discontinuation of treatment

  • Incidence of AEs leading to Discontinuation

    Time frame: From Day 1 up to 135 Days after discontinuation of treatment

  • Incidence of Serious Adverse Events (SAEs)

    Time frame: From signature of Informed Consent up to 135 Days after discontinuation of treatment

  • Incidence of Select AEs

    Time frame: From Day 1 up to 135 Days after discontinuation of treatment

  • Incidence of Immune-Mediated AEs

    Time frame: From Day 1 up to 135 Days after discontinuation of treatment

  • Incidence of Death

    Time frame: From signature of Informed Consent up to 135 Days after discontinuation of treatment

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Inclusion Criteria * Signed Written Informed Consent. * Eligible to receive continued study treatment per the Parent Study, including treatment beyond progression per investigator assessment in the Parent Study. * On treatment hold in the Parent Study following long-lasting response or are eligible for treatment rechallenge as defined in the Parent Study. * WOCBP and male participants who are sexually active must agree to follow instructions for method(s) of contraception as described below and included in the ICF. Exclusion Criteria * Participant is not eligible for study treatment per the Parent Study eligibility criteria. * Participants not receiving clinical benefit as assessed by the Investigator. * Any clinical adverse event (AE), laboratory abnormality, or intercurrent illness which, in the opinion of the Investigator, indicates that participation in the study is not in the best interest of the participant. * Other protocol-defined Inclusion/Exclusion Criteria apply

Study locations (59)

Local Institution - 0220

Huntsville, Alabama, 35801

Completed

University of Arizona College of Medicine

Tucson, Arizona, 85724

Withdrawn

Innovative Clinical Research Institute

Lynwood, California, 90262

Withdrawn

Local Institution

San Francisco, California, 94115

Withdrawn

Local Institution - 0099

San Francisco, California, 94143

Completed

Local Institution - 0233

Aurora, Colorado, 80045

Completed

Local Institution - 0095

New Haven, Connecticut, 06520

Withdrawn

Local Institution - 0088

Washington D.C., District of Columbia, 20007-2113

Completed

Florida Cancer Affiliates

Ocala, Florida, 34474

Withdrawn

Local Institution

Orlando, Florida, 32806

Withdrawn

Local Institution - 0024

Tampa, Florida, 33612

Completed

Local Institution - 0105

Chicago, Illinois, 60637

Completed

Local Institution

Maywood, Illinois, 60153

Withdrawn

Local Institution - 0279

Park Ridge, Illinois, 60068

Completed

Local Institution - 0186

Westwood, Kansas, 66205

Completed

Local Institution - 0165

Wichita, Kansas, 67214-3728

Completed

University of Louisville-James Graham Brown Cancer Center

Louisville, Kentucky, 40202

Recruiting
Jason Chesney, Site 0059 · Contact

Local Institution - 0092

Baltimore, Maryland, 21287

Completed

Local Institution - 0039

Boston, Massachusetts, 02114

Completed

Dana_Farber Cancer Institute (DFCI)

Boston, Massachusetts, 02215

Recruiting
David Reardon, Site 0082 · Contact

Local Institution - 0081

Boston, Massachusetts, 02215

Withdrawn

Local Institution - 0143

Ann Arbor, Michigan, 48109-5008

Completed

Local Institution - 0100

Minneapolis, Minnesota, 55407-3723

Completed

Local Institution

St Louis, Missouri, 63110

Withdrawn

Local Institution - 0205

Omaha, Nebraska, 68130

Completed

Local Institution - 0014

Lebanon, New Hampshire, 03756

Completed

Local Institution

Albuquerque, New Mexico, 87131

Withdrawn

Roswell Park Cancer Institute

Buffalo, New York, 14263

Recruiting
Saby George, Site 0128 · Contact

NYU Langone Hematology Oncology Associates-Mineola

Mineola, New York, 11501

Recruiting
Jeffery Schneider, Site 0413 · Contact

Local Institution

New York, New York, 10016

Withdrawn

Local Institution - 0185

New York, New York, 10065

Completed

Local Institution - 0202

New York, New York, 10065

Withdrawn

Local Institution

New York, New York, 10065

Withdrawn

Local Institution - 0204

Charlotte, North Carolina, 28204

Completed

Local Institution - 0016

Durham, North Carolina, 27705

Completed

Oncology Hematology Care

Cincinnati, Ohio, 45242

Recruiting
Patrick Ward, Site 0085 · Contact

Local Institution - 0408

Cincinnati, Ohio, 45267

Active Not Recruiting

Local Institution

Cleveland, Ohio, 44106

Withdrawn

The Ohio University

Columbus, Ohio, 43210

Recruiting
Asrar Alahmadi, Site 0103 · Contact

Local Institution - 0246

Tulsa, Oklahoma, 74146

Withdrawn

Local Institution - 0037

Allentown, Pennsylvania, 18103

Completed

Local Institution - 0054

Easton, Pennsylvania, 18045

Completed

Lancaster General Health

Lancaster, Pennsylvania, 17601

Recruiting
Samuel Kerr, Site 0400 · Contact

Allegheny Valley Hospital

Natrona Heights, Pennsylvania, 15065

Withdrawn

Local Institution

Philadelphia, Pennsylvania, 19104

Withdrawn

Local Institution - 0162

Philadelphia, Pennsylvania, 19111

Withdrawn

Local Institution - 0110

Pittsburgh, Pennsylvania, 15213

Completed

Local Institution - 0228

Charleston, South Carolina, 29414

Completed

Local Institution

Greenville, South Carolina, 29615

Withdrawn

Local Institution

Chattanooga, Tennessee, 37404

Withdrawn

Tennesse Oncology

Nashville, Tennessee, 37203

Recruiting
David Spigel, Site 0130 · Contact

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

Withdrawn

Local Institution

Dallas, Texas, 75390

Withdrawn

Local Institution - 0364

Houston, Texas, 77030-4000

Withdrawn

Local Institution - 0055

Salt Lake City, Utah, 84112-5550

Completed

Local Institution

Charlottesville, Virginia, 22908

Withdrawn

Public Hospital of King County District 1 Valley Medical Center

Renton, Washington, 98055

Withdrawn

Local Institution - 0065

Madison, Wisconsin, 53792

Completed

Local Institution - 0124

Madison, Wisconsin, 53792

Withdrawn