Pan Tumor Rollover Study

Phase 2

Recruiting

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

• Registration Number: NCT03899155
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-01
• Study First Submitted QC: 2019-04-01
• Study First Posted: 2019-04-02
• Study Start: 2019-08-09
• Status Verified: 2025-10
• Last Update Submitted: 2025-10-03
• Last Update Posted: 2025-10-06
• Primary Completion: 2029-08-25
• Study Completion: 2029-08-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C10: Relatlimab + Nivolumab SAV Dose 4	Relatlimab	-
C8: Relatlimab + Nivolumab SAV + PDCT Dose 1	Nivolumab	-
C10: Relatlimab + Nivolumab SAV Dose 4	Nivolumab	-
C12: Relatlimab + Nivolumab SAV Dose 5	Nivolumab	-
E3: Leucovorin + Fluorouracil	Leucovorin	-
D1: Nivolumab + Temozolomide	Nivolumab	-
C9: Relatlimab + Nivolumab SAV + Bevacizumab	Nivolumab	-
A2: Nivolumab Monotherapy Dose 2	Nivolumab	-
B2: Nivolumab + Ipilimumab + Cabozantinib	Cabozantinib	-
C1: Relatlimab + Nivolumab Fixed Dose Combination Dose 1	Nivolumab + Relatlimab	-
A1: Nivolumab Monotherapy Dose 1	Nivolumab	-
B3: Nivolumab + Ipilimumab + Trametinib	Trametinib	-
C3: Relatlimab + Nivolumab Fixed Dose Combination Dose 2	Nivolumab + Relatlimab	-
C6: Relatlimab + Nivolumab + Capecitabine	Nivolumab + Relatlimab	-
C7: Relatlimab + Nivolumab SAV Dose 3	Nivolumab	-
B3: Nivolumab + Ipilimumab + Trametinib	Nivolumab	-
C11: Relatlimab + Nivolumab SAV + PDCT Dose 2	Relatlimab	-
D1: Nivolumab + Temozolomide	Temozolomide	-
E2: Regorafinib Monotherapy	Regorafinib	-
E8: Capecitabine Monotherapy	Capecitabine	-
E10: Pemetrexed Monotherapy	Pemetrexed	-
D2: Nivolumab + Rucaparib	Rucaparib	-
C6: Relatlimab + Nivolumab + Capecitabine	Capecitabine	-
B3: Nivolumab + Ipilimumab + Trametinib	Ipilimumab	-
B1: Nivolumab + Ipilimumab	Nivolumab	-
B1: Nivolumab + Ipilimumab	Ipilimumab	-
B2: Nivolumab + Ipilimumab + Cabozantinib	Nivolumab	-
B2: Nivolumab + Ipilimumab + Cabozantinib	Ipilimumab	-
C2: Relatlimab + Nivolumab Single Agent Vial (SAV) Dose 1	Nivolumab	-
C5: Relatlimab + Nivolumab + Ipilimumab	Ipilimumab	-
C4: Relatlimab + Nivolumab SAV Dose 2	Nivolumab	-
C5: Relatlimab + Nivolumab + Ipilimumab	Nivolumab	-
C7: Relatlimab + Nivolumab SAV Dose 3	Relatlimab	-
C12: Relatlimab + Nivolumab SAV Dose 5	Relatlimab	-
D2: Nivolumab + Rucaparib	Nivolumab	-
C9: Relatlimab + Nivolumab SAV + Bevacizumab	Relatlimab	-
C11: Relatlimab + Nivolumab SAV + PDCT Dose 2	Nivolumab	-
C9: Relatlimab + Nivolumab SAV + Bevacizumab	Bevacizumab	-
D3: Nivolumab + Daratumumab	Nivolumab	-
D3: Nivolumab + Daratumumab	Daratumumab	-
D4: Nivolumab + Bevacizumab	Nivolumab	-
E1: Bevacizumab Monotherapy	Bevacizumab	-
E4: Leucovorin + Oxaliplatin + Fluorouracil	Leucovorin	-
E4: Leucovorin + Oxaliplatin + Fluorouracil	Fluorouracil	-
E4: Leucovorin + Oxaliplatin + Fluorouracil	Oxaliplatin	-
E5: Enzalutamide Monotherapy	Enzalutamide	-
E6: Sunitinib Monotherapy	Sunitinib	-
E7: Rucaparib Monotherapy	Rucaparib	-
E9: Cabozantinib Monotherapy	Cabozantinib	-
E11: Pembrolizumab Monotherapy	Pembrolizumab	-
C2: Relatlimab + Nivolumab Single Agent Vial (SAV) Dose 1	Relatlimab	-
C4: Relatlimab + Nivolumab SAV Dose 2	Relatlimab	-
C8: Relatlimab + Nivolumab SAV + PDCT Dose 1	Relatlimab	-

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Events (AEs)	From Day 1 up to 135 Days after discontinuation of treatment
Incidence of AEs leading to Discontinuation	From Day 1 up to 135 Days after discontinuation of treatment
Incidence of Serious Adverse Events (SAEs)	From signature of Informed Consent up to 135 Days after discontinuation of treatment
Incidence of Death	From signature of Informed Consent up to 135 Days after discontinuation of treatment
Incidence of drug related AEs	From Day 1 up to 135 Days after discontinuation of treatment
Incidence of Select AEs	From Day 1 up to 135 Days after discontinuation of treatment
Incidence of Immune-Mediated AEs	From Day 1 up to 135 Days after discontinuation of treatment

Trial Locations

Locations (352)

Local Institution - 0220; 🇺🇸 Huntsville, Alabama, United States

University of Arizona College of Medicine; 🇺🇸 Tucson, Arizona, United States

Innovative Clinical Research Institute; 🇺🇸 Lynwood, California, United States

Local Institution; 🇸🇪 Umeå, Sweden

Local Institution - 0099; 🇺🇸 San Francisco, California, United States

Local Institution - 0233; 🇺🇸 Aurora, Colorado, United States

Local Institution - 0095; 🇺🇸 New Haven, Connecticut, United States

Local Institution - 0088; 🇺🇸 Washington D.C., District of Columbia, United States

Florida Cancer Affiliates; 🇺🇸 Ocala, Florida, United States

Local Institution - 0024; 🇺🇸 Tampa, Florida, United States

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