Pan Tumor Rollover Study

Purpose

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

Condition

  • Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy 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 Design

Phase
Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
A1: Nivolumab Monotherapy Dose 1
  • Drug: Nivolumab
    Specified dose on specified days
    Other names:
    • BMS-936558-01
Experimental
A2: Nivolumab Monotherapy Dose 2
  • Drug: Nivolumab
    Specified dose on specified days
    Other names:
    • BMS-936558-01
Experimental
B1: Nivolumab + Ipilimumab
  • Drug: Nivolumab
    Specified dose on specified days
    Other names:
    • BMS-936558-01
  • Drug: Ipilimumab
    Specified dose on specified days
Experimental
B2: Nivolumab + Ipilimumab + Cabozantinib
  • Drug: Nivolumab
    Specified dose on specified days
    Other names:
    • BMS-936558-01
  • Drug: Ipilimumab
    Specified dose on specified days
  • Drug: Cabozantinib
    Specified dose on specified days
Experimental
B3: Nivolumab + Ipilimumab + Trametinib
  • Drug: Nivolumab
    Specified dose on specified days
    Other names:
    • BMS-936558-01
  • Drug: Ipilimumab
    Specified dose on specified days
  • Drug: Trametinib
    Specified dose on specified days
Experimental
C1: Relatlimab + Nivolumab Fixed Dose Combination Dose 1
  • Drug: Nivolumab + Relatlimab
    Specified dose on specified days
    Other names:
    • BMS-986213
Experimental
C3: Relatlimab + Nivolumab Fixed Dose Combination Dose 2
  • Drug: Nivolumab + Relatlimab
    Specified dose on specified days
    Other names:
    • BMS-986213
Experimental
C2: Relatlimab + Nivolumab Single Agent Vial (SAV) Dose 1
  • Drug: Nivolumab
    Specified dose on specified days
    Other names:
    • BMS-936558-01
  • Drug: Relatlimab
    Specified dose on specified days
    Other names:
    • BMS-986016-01
Experimental
C4: Relatlimab + Nivolumab SAV Dose 2
  • Drug: Nivolumab
    Specified dose on specified days
    Other names:
    • BMS-936558-01
  • Drug: Relatlimab
    Specified dose on specified days
    Other names:
    • BMS-986016-01
Experimental
C5: Relatlimab + Nivolumab + Ipilimumab
  • Drug: Nivolumab
    Specified dose on specified days
    Other names:
    • BMS-936558-01
  • Drug: Ipilimumab
    Specified dose on specified days
Experimental
C6: Relatlimab + Nivolumab + Capecitabine
  • Drug: Nivolumab + Relatlimab
    Specified dose on specified days
    Other names:
    • BMS-986213
  • Drug: Capecitabine
    Specified dose on specified days
Experimental
C7: Relatlimab + Nivolumab SAV Dose 3
  • Drug: Nivolumab
    Specified dose on specified days
    Other names:
    • BMS-936558-01
  • Drug: Relatlimab
    Specified dose on specified days
    Other names:
    • BMS-986016-01
Experimental
C10: Relatlimab + Nivolumab SAV Dose 4
  • Drug: Nivolumab
    Specified dose on specified days
    Other names:
    • BMS-936558-01
  • Drug: Relatlimab
    Specified dose on specified days
    Other names:
    • BMS-986016-01
Experimental
C12: Relatlimab + Nivolumab SAV Dose 5
  • Drug: Nivolumab
    Specified dose on specified days
    Other names:
    • BMS-936558-01
  • Drug: Relatlimab
    Specified dose on specified days
    Other names:
    • BMS-986016-01
Experimental
C8: Relatlimab + Nivolumab SAV + PDCT Dose 1
  • Drug: Nivolumab
    Specified dose on specified days
    Other names:
    • BMS-936558-01
  • Drug: Relatlimab
    Specified dose on specified days
    Other names:
    • BMS-986016-01
Experimental
C9: Relatlimab + Nivolumab SAV + Bevacizumab
  • Drug: Nivolumab
    Specified dose on specified days
    Other names:
    • BMS-936558-01
  • Drug: Relatlimab
    Specified dose on specified days
    Other names:
    • BMS-986016-01
  • Drug: Bevacizumab
    Specified dose on specified days
Experimental
C11: Relatlimab + Nivolumab SAV + PDCT Dose 2
  • Drug: Nivolumab
    Specified dose on specified days
    Other names:
    • BMS-936558-01
  • Drug: Relatlimab
    Specified dose on specified days
    Other names:
    • BMS-986016-01
Experimental
D1: Nivolumab + Temozolomide
  • Drug: Nivolumab
    Specified dose on specified days
    Other names:
    • BMS-936558-01
  • Drug: Temozolomide
    Specified dose on specified days
Experimental
D2: Nivolumab + Rucaparib
  • Drug: Nivolumab
    Specified dose on specified days
    Other names:
    • BMS-936558-01
  • Drug: Rucaparib
    Specified dose on specified days
Experimental
D3: Nivolumab + Daratumumab
  • Drug: Nivolumab
    Specified dose on specified days
    Other names:
    • BMS-936558-01
  • Drug: Daratumumab
    Specified dose on specified days
Experimental
D4: Nivolumab + Bevacizumab
  • Drug: Nivolumab
    Specified dose on specified days
    Other names:
    • BMS-936558-01
Experimental
E1: Bevacizumab Monotherapy
  • Drug: Bevacizumab
    Specified dose on specified days
Experimental
E2: Regorafinib Monotherapy
  • Drug: Regorafinib
    Specified dose on specified days
Experimental
E4: Leucovorin + Oxaliplatin + Fluorouracil
  • Drug: Leucovorin
    Specified dose on specified days
  • Drug: Fluorouracil
    Specified dose on specified days
  • Drug: Oxaliplatin
    Specified dose on specified days
Experimental
E5: Enzalutamide Monotherapy
  • Drug: Enzalutamide
    Specified dose on specified days
Experimental
E6: Sunitinib Monotherapy
  • Drug: Sunitinib
    Specified dose on specified days
Experimental
E7: Rucaparib Monotherapy
  • Drug: Rucaparib
    Specified dose on specified days
Experimental
E8: Capecitabine Monotherapy
  • Drug: Capecitabine
    Specified dose on specified days
Experimental
E9: Cabozantinib Monotherapy
  • Drug: Cabozantinib
    Specified dose on specified days
Experimental
E10: Pemetrexed Monotherapy
  • Drug: Pemetrexed
    Specified dose on specified days
Experimental
E11: Pembrolizumab Monotherapy
  • Drug: Pembrolizumab
    Specified dose on specified days
Experimental
E3: Leucovorin + Fluorouracil
  • Drug: Leucovorin
    Specified dose on specified days

Recruiting Locations

University of Louisville-James Graham Brown Cancer Center
Louisville, Kentucky 40202
Contact:
Jason Chesney, Site 0059
502-562-2280

Dana_Farber Cancer Institute (DFCI)
Boston, Massachusetts 02215
Contact:
David Reardon, Site 0082
617-632-2166

Roswell Park Cancer Institute
Buffalo, New York 14263
Contact:
Saby George, Site 0128
716-845-8387

NYU Langone Hematology Oncology Associates-Mineola
Mineola, New York 11501
Contact:
Jeffery Schneider, Site 0413
516-578-2408

Oncology Hematology Care
Cincinnati, Ohio 45242
Contact:
Patrick Ward, Site 0085
513-751-2273

The Ohio University
Columbus, Ohio 43210
Contact:
Asrar Alahmadi, Site 0103
202-361-4528

Lancaster General Health
Lancaster, Pennsylvania 17601
Contact:
Samuel Kerr, Site 0400
717-215-9561

Tennesse Oncology
Nashville, Tennessee 37203
Contact:
David Spigel, Site 0130
615-320-5090

FDI Clinical Research
San Juan, PR, Puerto Rico 00927
Contact:
Mirelis Acosta-Rivera, Site 0334
7877520003545

More Details

Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
855-907-3286
Clinical.Trials@bms.com