The trial is taking place at:
A

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Pan Tumor Rollover Study

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Enrolling
Phase 2

Conditions

Cancer

Treatments

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

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)

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: Ipilimumab
Drug: Cabozantinib
Drug: Nivolumab
B3: Nivolumab + Ipilimumab + Trametinib
Experimental group
Treatment:
Drug: Ipilimumab
Drug: Trametinib
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: Relatlimab
Drug: Bevacizumab
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: Rucaparib
Drug: Nivolumab
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: Fluorouracil
Drug: Oxaliplatin
Drug: Leucovorin
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

Trial contacts and locations

349

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Central trial contact

BMS Study Connect Contact http://www.bmsstudyconnect.com/; First line of the email MUST contain NCT# and Site#

Data sourced from clinicaltrials.gov

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