Pan Tumor Rollover Study
ConditionCancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBristol-Myers Squibb
About this trial
Main Objective of this study is to examine long-term safety of nivolumab monotherapy including combinations and other cancer therapies in various tumor types.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
Nivolumab
DrugSpecified dose on specified days
Ipilimumab
DrugSpecified dose on specified days
Cabozantinib
DrugSpecified dose on specified days
Trametinib
DrugSpecified dose on specified days
Relatlimab
DrugSpecified dose on specified days
Nivolumab + Relatlimab
DrugSpecified dose on specified days
Capecitabine
DrugSpecified dose on specified days
Bevacizumab
DrugSpecified dose on specified days
Temozolomide
DrugSpecified dose on specified days
Rucaparib
DrugSpecified dose on specified days
Daratumumab
DrugSpecified dose on specified days
Regorafinib
DrugSpecified dose on specified days
Leucovorin
DrugSpecified dose on specified days
Fluorouracil
DrugSpecified dose on specified days
Oxaliplatin
DrugSpecified dose on specified days
Enzalutamide
DrugSpecified dose on specified days
Sunitinib
DrugSpecified dose on specified days
Pemetrexed
DrugSpecified dose on specified days
Pembrolizumab
DrugSpecified dose on specified days
Treatment groups
1,500 Participants
are divided into 32 treatment groups32
Treatment groupsSee each treatment group below.
Group A: A1: Nivolumab Monotherapy Dose 1Experimental treatment 1 intervention
Group B: A2: Nivolumab Monotherapy Dose 2Experimental treatment 1 intervention
Group C: B1: Nivolumab + IpilimumabExperimental treatment 2 interventions
Group D: B2: Nivolumab + Ipilimumab + CabozantinibExperimental treatment 3 interventions
Group E: B3: Nivolumab + Ipilimumab + TrametinibExperimental treatment 3 interventions
Group F: C1: Relatlimab + Nivolumab Fixed Dose Combination Dose 1Experimental treatment 1 intervention
Group G: C3: Relatlimab + Nivolumab Fixed Dose Combination Dose 2Experimental treatment 1 intervention
Group H: C2: Relatlimab + Nivolumab Single Agent Vial (SAV) Dose 1Experimental treatment 2 interventions
Group I: C4: Relatlimab + Nivolumab SAV Dose 2Experimental treatment 2 interventions
Group J: C5: Relatlimab + Nivolumab + IpilimumabExperimental treatment 2 interventions
Group K: C6: Relatlimab + Nivolumab + CapecitabineExperimental treatment 2 interventions
Group L: C7: Relatlimab + Nivolumab SAV Dose 3Experimental treatment 2 interventions
Group M: C10: Relatlimab + Nivolumab SAV Dose 4Experimental treatment 2 interventions
Group N: C12: Relatlimab + Nivolumab SAV Dose 5Experimental treatment 2 interventions
Group O: C8: Relatlimab + Nivolumab SAV + PDCT Dose 1Experimental treatment 2 interventions
Group P: C9: Relatlimab + Nivolumab SAV + BevacizumabExperimental treatment 3 interventions
Group Q: C11: Relatlimab + Nivolumab SAV + PDCT Dose 2Experimental treatment 2 interventions
Group R: D1: Nivolumab + TemozolomideExperimental treatment 2 interventions
Group S: D2: Nivolumab + RucaparibExperimental treatment 2 interventions
Group T: D3: Nivolumab + DaratumumabExperimental treatment 2 interventions
Group U: D4: Nivolumab + BevacizumabExperimental treatment 1 intervention
Group V: E1: Bevacizumab MonotherapyExperimental treatment 1 intervention
Group W: E2: Regorafinib MonotherapyExperimental treatment 1 intervention
Group X: E4: Leucovorin + Oxaliplatin + FluorouracilExperimental treatment 3 interventions
Group Y: E5: Enzalutamide MonotherapyExperimental treatment 1 intervention
Group Z: E6: Sunitinib MonotherapyExperimental treatment 1 intervention
Group [: E7: Rucaparib MonotherapyExperimental treatment 1 intervention
Group \: E8: Capecitabine MonotherapyExperimental treatment 1 intervention
Group ]: E9: Cabozantinib MonotherapyExperimental treatment 1 intervention
Group ^: E10: Pemetrexed MonotherapyExperimental treatment 1 intervention
Group _: E11: Pembrolizumab MonotherapyExperimental treatment 1 intervention
Group `: E3: Leucovorin + FluorouracilExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Adverse Events (AEs)
Time frame
From Day 1 up to 135 Days after discontinuation of treatment2
Incidence of drug related AEs
Time frame
From Day 1 up to 135 Days after discontinuation of treatment3
Incidence of AEs leading to Discontinuation
Time frame
From Day 1 up to 135 Days after discontinuation of treatment4
Incidence of Serious Adverse Events (SAEs)
Time frame
From signature of Informed Consent up to 135 Days after discontinuation of treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Bristol-Myers Squibb
Lead sponsor
Exelixis
Collaborator
Novartis
Collaborator
Clovis Oncology, Inc.
Collaborator
Janssen Pharmaceuticals
Collaborator
Source ClinicalTrials.gov