Immuno-Oncology Drugs Elotuzumab, Anti-LAG-3 and Anti-TIGIT
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|ClinicalTrials.gov Identifier: NCT04150965|
Recruitment Status : Recruiting
First Posted : November 5, 2019
Last Update Posted : September 10, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma Relapsed Refractory Multiple Myeloma||Drug: Elotuzumab, pomalidomide, dexamethasone Drug: Anti-LAG-3 Drug: Anti-LAG-3 + Pomalidimide + Dexamethasone Drug: Anti-TIGIT Drug: Anti-TIGIT + Pomalidimide + Dexamethasone||Phase 1 Phase 2|
This study will enroll 104 patients to one of three treatment arms. The study is open to patients relapsing with refractory Multiple Myeloma who have:
- received 3 prior lines of therapy
exposed to each of these 3 drug classes:
- proteasome inhibitors, and
- anti-CD38 monoclonal antibody
relapsed and refractory are defined using the IMWG criteria:
- disease that is non-responsive while on salvage therapy or progresses within 60 days of last therapy in patients who have achieved minimal response or better at some point previously to then progressing in their disease course.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||104 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||
Arm B: Anti-LAG-3 will treat patients with single agent for Cycle 1. In Cycle 2 and beyond Arm B combination Anti-LAG-3 + Pomalidomide + Dexamethasone.
Arm C: Anti-TIGIT will treat patients with single agent for Cycle 1. In Cycle 2 and beyond Arm C combination Anti-TIGIT + Pomalidomide + Dexamethasone.
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Assessment of Combination Immuno-Oncology Drugs Elotuzumab, Anti-LAG-3 (BMS-986016) and Anti-TIGIT (BMS-986207)|
|Actual Study Start Date :||June 30, 2020|
|Estimated Primary Completion Date :||December 18, 2024|
|Estimated Study Completion Date :||December 18, 2024|
Active Comparator: Arm A - Elotuzumab
Patients receive Elotuzumab in combination with pomalidomide and dexamethasone. Arm A begings in Phase 2 portion.
Drug: Elotuzumab, pomalidomide, dexamethasone
Study Patients with relapsed Multiple Myeloma will receive: Elotuzumab, Pomalidomide, and Dexamethasone Starting in Phase 2 Cycle 1 Day 1 forward. Each cycle is 28 days long.
Other Name: Empliciti
Experimental: Arm B - Anti LAG-3 Single Agent
Patients receive Anti-LAG-3 as a single agent for 1 Cycle in Phase 1 portion.
Patients with relapsed Multiple Myeloma will receive: Anti -LAG-3 single agent for Cycle 1. Each Cycle is 28 days
Cycle 2 forward patients will receive Anti-LAG-3 in combination with pomalidomide and dexamethasone from Cycle 2 forward. Each cycle is 28 days long.
Experimental: Arm B:Combination Anti LAG-3 +Pomalidomide+Dexamethasone
Cycle 2 and beyond Patients receive Anti-LAG-3 in combination with pomalidomide and dexamethasone.
Drug: Anti-LAG-3 + Pomalidimide + Dexamethasone
Patients with Relapsed & Refractory Multiple Myeloma will receive: Anti-LAG-3 in combination with pomalidomide and dexamethasone from Cycle 2 forward. Each cycle is 28 days.
Experimental: Arm C - Anti-TIGIT Single Agent
Patients receive Anti-TIGIT as a single agent for 1 Cycle in Phase 1 portion.
Patients with relapsed Multiple Myeloma will receive: Anti -TIGIT single agent for Cycle 1.
Each cycle is 28 days.
Other Name: BMS-986207
Experimental: ARM C: Anti-TIGIT +Pomalidomide+Dexamethasone
Cycle 2 and beyond Patients receive Anti-TIGIT in combination with pomalidomide and dexamethasone.
Drug: Anti-TIGIT + Pomalidimide + Dexamethasone
Cycle 2 and beyond patients will receive Anti-TIGIT in combination with pomalidomide and dexamethasone from Cycle 2 forward. Each cycle is 28 days..
Other Name: BMS-986207
- Overall Response Rate [ Time Frame: Patients will be evaluated monthly for response from the start of the study until the date of documented disease progression, assessed up to 18 months. ]The overall response rate of the drug combination, in each Arm for RRMM, which is defined as the proportion of subjects who achieved a response (≥ VGPR).
- Frequency, type and grade of Adverse Events and Serious Adverse Events [ Time Frame: Cycle 1 (28 days) ]Frequency, type and grade of Adverse Events and Serious Adverse Events during Cycle 1 of Single agent Arms B and C. In Combination for all Arms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04150965
|Contact: MMRF - Nurse Patient Navigator Patient Navigation Center, RN, BSN, OCNfirstname.lastname@example.org|
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|Contact: Madhav V. Dhodapkar, M.D.|
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center||Not yet recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: David Avigan, M.D.|
|Dana Farber Cancer Institute||Not yet recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Omar Nadeem, M.D.|
|United States, Michigan|
|University of Michigan||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Matthew Pianko, M.D.|
|United States, Missouri|
|Washington University School of Medicine Division of Medical Oncology||Recruiting|
|Saint Louis, Missouri, United States, 63110|
|Contact: Ravi Vij, MD, MBA 314-454-8304|
|United States, New Jersey|
|Hackensack Meridian Medical Center||Recruiting|
|Hackensack, New Jersey, United States, 07601|
|Contact: Noa Biran, M.D.|
|United States, New York|
|Mount Sinai School of Medicine||Recruiting|
|New York, New York, United States, 10029|
|Contact: Shambavi Richard, M.D.|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Alex Lesokhin, M.D. 646-608-3717|
|United States, North Carolina|
|Levine Cancer Institute||Recruiting|
|Charlotte, North Carolina, United States, 28204|
|Contact: Barry Paul, M.D.|
|United States, Texas|
|UT Southwestern Medical Center||Recruiting|
|Dallas, Texas, United States, 75390|
|Contact: Larry Anderson, M.D.|
|Principal Investigator:||Madhav V. Dhodapkar, M.D.||Medical Monitor|
|Principal Investigator:||Hearn J. Cho, M.D., Ph.D.||Chief Medical Officer|
|Principal Investigator:||Daniel Auclair, Ph.D.||Chief Scientific Officer|