Pan Tumor Rollover Study

Bristol-Myers Squibb (BMS)

Status and phase: Enrolling; Phase 2

Conditions: Cancer

Treatments: Drug: Temozolomide; Drug: Capecitabine; Drug: Rucaparib; Drug: Nivolumab; Drug: Fluorouracil; Drug: Enzalutamide; Drug: Pemetrexed; Drug: Nivolumab + Relatlimab; Drug: Leucovorin; Drug: Regorafinib; Drug: Ipilimumab; Drug: Pembrolizumab; Drug: Relatlimab; Drug: Daratumumab; Drug: Cabozantinib; Drug: Sunitinib; Drug: Bevacizumab; Drug: Oxaliplatin; Drug: Trametinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT03899155

2018-004362-34 (EudraCT Number)

CA209-8TT

Details and patient eligibility

About

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

Enrollment: 1,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,500 participants in 32 patient groups

A1: Nivolumab Monotherapy Dose 1

Experimental group

Treatment:

Drug: Nivolumab

A2: Nivolumab Monotherapy Dose 2

Experimental group

Treatment:

Drug: Nivolumab

B1: Nivolumab + Ipilimumab

Experimental group

Treatment:

Drug: Ipilimumab

Drug: Nivolumab

B2: Nivolumab + Ipilimumab + Cabozantinib

Experimental group

Treatment:

Drug: Cabozantinib

Drug: Ipilimumab

Drug: Nivolumab

B3: Nivolumab + Ipilimumab + Trametinib

Experimental group

Treatment:

Drug: Trametinib

Drug: Ipilimumab

Drug: Nivolumab

C1: Relatlimab + Nivolumab Fixed Dose Combination Dose 1

Experimental group

Treatment:

Drug: Nivolumab + Relatlimab

C3: Relatlimab + Nivolumab Fixed Dose Combination Dose 2

Experimental group

Treatment:

Drug: Nivolumab + Relatlimab

C2: Relatlimab + Nivolumab Single Agent Vial (SAV) Dose 1

Experimental group

Treatment:

Drug: Relatlimab

Drug: Nivolumab

C4: Relatlimab + Nivolumab SAV Dose 2

Experimental group

Treatment:

Drug: Relatlimab

Drug: Nivolumab

C5: Relatlimab + Nivolumab + Ipilimumab

Experimental group

Treatment:

Drug: Ipilimumab

Drug: Nivolumab

C6: Relatlimab + Nivolumab + Capecitabine

Experimental group

Treatment:

Drug: Nivolumab + Relatlimab

Drug: Capecitabine

C7: Relatlimab + Nivolumab SAV Dose 3

Experimental group

Treatment:

Drug: Relatlimab

Drug: Nivolumab

C10: Relatlimab + Nivolumab SAV Dose 4

Experimental group

Treatment:

Drug: Relatlimab

Drug: Nivolumab

C12: Relatlimab + Nivolumab SAV Dose 5

Experimental group

Treatment:

Drug: Relatlimab

Drug: Nivolumab

C8: Relatlimab + Nivolumab SAV + PDCT Dose 1

Experimental group

Treatment:

Drug: Relatlimab

Drug: Nivolumab

C9: Relatlimab + Nivolumab SAV + Bevacizumab

Experimental group

Treatment:

Drug: Bevacizumab

Drug: Relatlimab

Drug: Nivolumab

C11: Relatlimab + Nivolumab SAV + PDCT Dose 2

Experimental group

Treatment:

Drug: Relatlimab

Drug: Nivolumab

D1: Nivolumab + Temozolomide

Experimental group

Treatment:

Drug: Nivolumab

Drug: Temozolomide

D2: Nivolumab + Rucaparib

Experimental group

Treatment:

Drug: Nivolumab

Drug: Rucaparib

D3: Nivolumab + Daratumumab

Experimental group

Treatment:

Drug: Daratumumab

Drug: Nivolumab

D4: Nivolumab + Bevacizumab

Experimental group

Treatment:

Drug: Nivolumab

E1: Bevacizumab Monotherapy

Experimental group

Treatment:

Drug: Bevacizumab

E2: Regorafinib Monotherapy

Experimental group

Treatment:

Drug: Regorafinib

E4: Leucovorin + Oxaliplatin + Fluorouracil

Experimental group

Treatment:

Drug: Oxaliplatin

Drug: Leucovorin

Drug: Fluorouracil

E5: Enzalutamide Monotherapy

Experimental group

Treatment:

Drug: Enzalutamide

E6: Sunitinib Monotherapy

Experimental group

Treatment:

Drug: Sunitinib

E7: Rucaparib Monotherapy

Experimental group

Treatment:

Drug: Rucaparib

E8: Capecitabine Monotherapy

Experimental group

Treatment:

Drug: Capecitabine

E9: Cabozantinib Monotherapy

Experimental group

Treatment:

Drug: Cabozantinib

E10: Pemetrexed Monotherapy

Experimental group

Treatment:

Drug: Pemetrexed

E11: Pembrolizumab Monotherapy

Experimental group

Treatment:

Drug: Pembrolizumab

E3: Leucovorin + Fluorouracil

Experimental group

Treatment:

Drug: Leucovorin