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Immuno-Oncology Drugs Elotuzumab, Anti-LAG-3 and Anti-TIGIT

NCT04150965 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2025-02-14

No results posted yet for this study

Summary

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.

Conditions

Interventions

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.

DRUG

Anti-LAG-3

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.

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.

DRUG

Anti-TIGIT

Patients with relapsed Multiple Myeloma will receive: Anti -TIGIT single agent for Cycle 1. Each cycle is 28 days.

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..

Sponsors & Collaborators

Principal Investigators

  • Madhav V. Dhodapkar, M.D. · Medical Monitor

  • Hearn J. Cho, M.D., Ph.D. · Chief Medical Officer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-10
Primary Completion
2024-08-30
Completion
2024-08-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04150965 on ClinicalTrials.gov