Pan Tumor Rollover Study

Part of paid clinical trials in Huntsville, Alabama.

Sponsor
Bristol-Myers Squibb
Study ID
NCT03899155
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    Specified dose on specified days
  • Ipilimumab — DRUG
    Specified dose on specified days
  • Cabozantinib — DRUG
    Specified dose on specified days
  • Trametinib — DRUG
    Specified dose on specified days
  • Relatlimab — DRUG
    Specified dose on specified days
  • Nivolumab + Relatlimab — DRUG
    Specified dose on specified days
  • Capecitabine — DRUG
    Specified dose on specified days
  • Bevacizumab — DRUG
    Specified dose on specified days
  • Temozolomide — DRUG
    Specified dose on specified days
  • Rucaparib — DRUG
    Specified dose on specified days
  • Daratumumab — DRUG
    Specified dose on specified days
  • Regorafinib — DRUG
    Specified dose on specified days
  • Leucovorin — DRUG
    Specified dose on specified days
  • Fluorouracil — DRUG
    Specified dose on specified days
  • Oxaliplatin — DRUG
    Specified dose on specified days
  • Enzalutamide — DRUG
    Specified dose on specified days
  • Sunitinib — DRUG
    Specified dose on specified days
  • Pemetrexed — DRUG
    Specified dose on specified days
  • Pembrolizumab — DRUG
    Specified dose on specified days

Study Details

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

Key Dates

Start date
Aug 9, 2019
Status verified
Jun 2026
Primary completion
Aug 25, 2029
Completion
Aug 25, 2029

Study Design

Enrollment
1,500 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: A1: Nivolumab Monotherapy Dose 1
  • Experimental: A2: Nivolumab Monotherapy Dose 2
  • Experimental: B1: Nivolumab + Ipilimumab
  • Experimental: B2: Nivolumab + Ipilimumab + Cabozantinib
  • Experimental: B3: Nivolumab + Ipilimumab + Trametinib
  • Experimental: C1: Relatlimab + Nivolumab Fixed Dose Combination Dose 1
  • Experimental: C3: Relatlimab + Nivolumab Fixed Dose Combination Dose 2
  • Experimental: C2: Relatlimab + Nivolumab Single Agent Vial (SAV) Dose 1
  • Experimental: C4: Relatlimab + Nivolumab SAV Dose 2
  • Experimental: C5: Relatlimab + Nivolumab + Ipilimumab
  • Experimental: C6: Relatlimab + Nivolumab + Capecitabine
  • Experimental: C7: Relatlimab + Nivolumab SAV Dose 3
  • Experimental: C10: Relatlimab + Nivolumab SAV Dose 4
  • Experimental: C12: Relatlimab + Nivolumab SAV Dose 5
  • Experimental: C8: Relatlimab + Nivolumab SAV + PDCT Dose 1
  • Experimental: C9: Relatlimab + Nivolumab SAV + Bevacizumab
  • Experimental: C11: Relatlimab + Nivolumab SAV + PDCT Dose 2
  • Experimental: D1: Nivolumab + Temozolomide
  • Experimental: D2: Nivolumab + Rucaparib
  • Experimental: D3: Nivolumab + Daratumumab
  • Experimental: D4: Nivolumab + Bevacizumab
  • Experimental: E1: Bevacizumab Monotherapy
  • Experimental: E2: Regorafinib Monotherapy
  • Experimental: E4: Leucovorin + Oxaliplatin + Fluorouracil
  • Experimental: E5: Enzalutamide Monotherapy
  • Experimental: E6: Sunitinib Monotherapy
  • Experimental: E7: Rucaparib Monotherapy
  • Experimental: E8: Capecitabine Monotherapy
  • Experimental: E9: Cabozantinib Monotherapy
  • Experimental: E10: Pemetrexed Monotherapy
  • Experimental: E11: Pembrolizumab Monotherapy
  • Experimental: E3: Leucovorin + Fluorouracil

Primary Outcome Measure

Incidence of Adverse Events (AEs) [ Time Frame: From Day 1 up to 135 Days after discontinuation of treatment ]

Central Contacts

  • BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
    855-907-3286
    [email protected]
  • First line of the email MUST contain NCT # and Site #.

Locations (59)

FacilityCityStateZIPSite coordinators
Local Institution - 0220HuntsvilleAlabama35801-
University of Arizona College of MedicineTucsonArizona85724-
Innovative Clinical Research InstituteLynwoodCalifornia90262-
Local InstitutionSan FranciscoCalifornia94115-
Local Institution - 0099San FranciscoCalifornia94143-
Local Institution - 0233AuroraColorado80045-
Local Institution - 0095New HavenConnecticut06520-
Local Institution - 0088Washington D.C.District of Columbia20007-2113-
Florida Cancer AffiliatesOcalaFlorida34474-
Local InstitutionOrlandoFlorida32806-
Local Institution - 0024TampaFlorida33612-
Local Institution - 0105ChicagoIllinois60637-
Local InstitutionMaywoodIllinois60153-
Local Institution - 0279Park RidgeIllinois60068-
Local Institution - 0186WestwoodKansas66205-
Local Institution - 0165WichitaKansas67214-3728-
University of Louisville-James Graham Brown Cancer CenterLouisvilleKentucky40202
Jason Chesney, Site 0059
502-562-2280
Local Institution - 0092BaltimoreMaryland21287-
Dana_Farber Cancer Institute (DFCI)BostonMassachusetts02215
David Reardon, Site 0082
617-632-2166
Local Institution - 0039BostonMassachusetts02114-
Local Institution - 0081BostonMassachusetts02215-
Local Institution - 0143Ann ArborMichigan48109-5008-
Local Institution - 0100MinneapolisMinnesota55407-3723-
Local InstitutionSt LouisMissouri63110-
Local Institution - 0205OmahaNebraska68130-
Local Institution - 0014LebanonNew Hampshire03756-
Local InstitutionAlbuquerqueNew Mexico87131-
Roswell Park Cancer InstituteBuffaloNew York14263
Saby George, Site 0128
716-845-8387
NYU Langone Hematology Oncology Associates-MineolaMineolaNew York11501
Jeffery Schneider, Site 0413
516-578-2408
Local InstitutionNew YorkNew York10016-
Local InstitutionNew YorkNew York10065-
Local Institution - 0185New YorkNew York10065-
Local Institution - 0202New YorkNew York10065-
Local Institution - 0204CharlotteNorth Carolina28204-
Local Institution - 0016DurhamNorth Carolina27705-
Local Institution - 0408CincinnatiOhio45267-
Oncology Hematology CareCincinnatiOhio45242
Patrick Ward, Site 0085
513-751-2273
Local InstitutionClevelandOhio44106-
The Ohio UniversityColumbusOhio43210
Asrar Alahmadi, Site 0103
202-361-4528
Local Institution - 0246TulsaOklahoma74146-
Local Institution - 0037AllentownPennsylvania18103-
Local Institution - 0054EastonPennsylvania18045-
Lancaster General HealthLancasterPennsylvania17601
Samuel Kerr, Site 0400
717-215-9561
Allegheny Valley HospitalNatrona HeightsPennsylvania15065-
Local InstitutionPhiladelphiaPennsylvania19104-
Local Institution - 0162PhiladelphiaPennsylvania19111-
Local Institution - 0110PittsburghPennsylvania15213-
Local Institution - 0228CharlestonSouth Carolina29414-
Local InstitutionGreenvilleSouth Carolina29615-
Local InstitutionChattanoogaTennessee37404-
Tennesse OncologyNashvilleTennessee37203
David Spigel, Site 0130
615-320-5090
Vanderbilt University Medical CenterNashvilleTennessee37232-
Local InstitutionDallasTexas75390-
Local Institution - 0364HoustonTexas77030-4000-
Local Institution - 0055Salt Lake CityUtah84112-5550-
Local InstitutionCharlottesvilleVirginia22908-
Public Hospital of King County District 1 Valley Medical CenterRentonWashington98055-
Local Institution - 0065MadisonWisconsin53792-
Local Institution - 0124MadisonWisconsin53792-

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