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 Genders
- 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
| Arm | Description | Assigned Intervention |
|---|---|---|
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Experimental A1: Nivolumab Monotherapy Dose 1 |
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Experimental A2: Nivolumab Monotherapy Dose 2 |
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Experimental B1: Nivolumab + Ipilimumab |
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Experimental B2: Nivolumab + Ipilimumab + Cabozantinib |
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Experimental B3: Nivolumab + Ipilimumab + Trametinib |
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Experimental C1: Relatlimab + Nivolumab Fixed Dose Combination Dose 1 |
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Experimental C3: Relatlimab + Nivolumab Fixed Dose Combination Dose 2 |
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Experimental C2: Relatlimab + Nivolumab Single Agent Vial (SAV) Dose 1 |
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Experimental C4: Relatlimab + Nivolumab SAV Dose 2 |
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Experimental C5: Relatlimab + Nivolumab + Ipilimumab |
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Experimental C6: Relatlimab + Nivolumab + Capecitabine |
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Experimental C7: Relatlimab + Nivolumab SAV Dose 3 |
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Experimental C10: Relatlimab + Nivolumab SAV Dose 4 |
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Experimental C12: Relatlimab + Nivolumab SAV Dose 5 |
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Experimental C8: Relatlimab + Nivolumab SAV + PDCT Dose 1 |
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Experimental C9: Relatlimab + Nivolumab SAV + Bevacizumab |
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Experimental C11: Relatlimab + Nivolumab SAV + PDCT Dose 2 |
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Experimental D1: Nivolumab + Temozolomide |
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Experimental D2: Nivolumab + Rucaparib |
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Experimental D3: Nivolumab + Daratumumab |
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Experimental D4: Nivolumab + Bevacizumab |
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Experimental E1: Bevacizumab Monotherapy |
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Experimental E2: Regorafinib Monotherapy |
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Experimental E4: Leucovorin + Oxaliplatin + Fluorouracil |
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Experimental E5: Enzalutamide Monotherapy |
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Experimental E6: Sunitinib Monotherapy |
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Experimental E7: Rucaparib Monotherapy |
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Experimental E8: Capecitabine Monotherapy |
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Experimental E9: Cabozantinib Monotherapy |
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Experimental E10: Pemetrexed Monotherapy |
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Experimental E11: Pembrolizumab Monotherapy |
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Experimental E3: Leucovorin + Fluorouracil |
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Recruiting Locations
Georgetown-Lombardi Comprehensive Cancer Center
Washington, District of Columbia 20007-2113
Washington, District of Columbia 20007-2113
Contact:
Michael Atkins, Site 0088
617-797-5460
Michael Atkins, Site 0088
617-797-5460
More Details
- Status
- Recruiting
- Sponsor
- Bristol-Myers Squibb
Study Contact
BMS Study Connect Contact http://www.bmsstudyconnect.com/855-907-3286
Clinical.Trials@bms.com