Recruiting

Phase 2

Observational StudyPan Tumor Rollover Study

Sponsor:

Bristol-Myers Squibb

Code:

NCT03899155

Conditions

Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Nivolumab

Ipilimumab

Cabozantinib

Trametinib

Relatlimab

Study Details

Brief 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.

Conditions

Cancer

Study ID

NCT03899155

Start date

Aug 9, 2019

Status verified date

Jul, 2026

Completion date

Aug 25, 2029

Anticipated

Primary completion date

Aug 25, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

1500 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Nivolumab