- Active, not recruiting
NCT04150965: Phase 1/2: Immuno-Oncology Drugs Elotuzumab, Anti-LAG-3 and Anti-TIGIT
Updated: Feb 10
Multiple Myeloma Research Consortium
MMRC-089: A Phase I/II Assessment of Combination Immuno-Oncology Drugs Elotuzumab, Anti-LAG-3 (BMS-986016) and Anti-TIGIT (BMS-986207)
NCT04150965: Phase 1/2: Immuno-Oncology Drugs Elotuzumab, Anti-LAG-3 and Anti-TIGIT
This a Phase I/II randomized trial for patients with relapsed refractory Multiple Myeloma who have relapsed after treatment with prior therapies. The protocol is designed to evaluate two agents, Anti-LAG-3 and Anti-TIGIT, in order to understand their immunologic effects and safety both as single agents and in combination with pomalidomide and dexamethasone. In these arms, patients will be treated with either Anti-LAG-3 or Anti-TIGIT respectively for one cycle as single agent followed by the addition of pomalidomide and dexamethasone in combination for subsequent cycles.
A third arm allows patients to be treated with the FDA approved combination of elotuzumab plus pomalidomide and dexamethsone as a control. This arm will thus allow a concurrent standard of care comparator for the experimental arms.
Sponsor
Multiple Myeloma Research Consortium
Collaborators
Bristol-Myers Squibb
Emory University
Washington University School of Medicine
Beth Israel Deaconess Medical Center
Dana-Farber Cancer Institute
Atrium Health
Memorial Sloan Kettering Cancer Center
Icahn School of Medicine at Mount Sinai
University of Texas
Hackensack Meridian Health
University of Michigan
ClinicalTrials.gov Identifier: NCT04136756
Official Title: A Phase I/II Assessment of Combination Immuno-Oncology Drugs Elotuzumab, Anti-LAG-3 (BMS-986016) and Anti-TIGIT (BMS-986207)
First Posted : November 5, 2019
Click here for details on ClinicalTrials.gov
Click here for details on cancer.gov
Anti-TIGIT monoclonal antibody BMS-986207
Relatlimab
Anti-LAG-3 Monoclonal Antibody BMS-986016
Drug: Elotuzumab, pomalidomide, dexamethasone
Drug: Anti-LAG-3
Drug: Anti-LAG-3 + Pomalidimide + Dexamethasone
Drug: Anti-TIGIT
Drug: Anti-TIGIT + Pomalidimide + Dexamethasone
Locations
United States, Georgia
United States, Massachusetts
United States, Michigan
United States, Missouri
United States, New Jersey
United States, New York
United States, North Carolina
United States, Texas