Melanoma Clinical Trial

A Study to Assess Safety and Efficacy of Relatlimab With Ipilimumab in Participants With Advanced Melanoma Who Progressed on Anti-Programmed Cell Death Protein 1 (Anti-PD-1) Treatment

Summary

The primary purpose of this study is to characterize the safety, tolerability, and dose-limiting toxicities (DLTs) and to determine the recommended dose of relatlimab in combination with ipilimumab (for dose escalation). It is also to evaluate the safety, tolerability, and preliminary efficacy of the recommended dose of relatlimab in combination with ipilimumab versus ipilimumab monotherapy (for dose expansion).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Must have documented progression while on a prior anti-programmed cell death protein 1 (PD-1) containing regimen limited to Nivolumab or Pembrolizumab
Must have histologically confirmed advanced unresectable (Stage III) or metastatic (Stage IV) melanoma, as per (AJCC) staging system
Tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses
Eastern Cooperative Oncology Group (ECOG) 0-1

Exclusion Criteria:

History of uveal melanoma
Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome
Prior treatment with ipilimumab, relatlimab, or any other cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) or lymphocyte-activation gene 3 (LAG-3) targeted agents

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

215

Study ID:

NCT03978611

Recruitment Status:

Active, not recruiting

Sponsor:

Bristol-Myers Squibb

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 29 Locations for this study

See Locations Near You

Local Institution - 0023
Tucson Arizona, 85724, United States
Local Institution - 0002
Los Angeles California, 90033, United States
Local Institution - 0005
Los Angeles California, 90033, United States
Local Institution - 0001
Santa Monica California, 90404, United States
Local Institution - 0015
Miami Florida, 33136, United States
Local Institution - 0004
Chicago Illinois, 60611, United States
Local Institution - 0003
Ann Arbor Michigan, 48109, United States
Local Institution - 0008
Morristown New Jersey, 07960, United States
Local Institution - 0018
Bruxelles Brussels, 1000, Belgium
Local Institution - 0017
Antwerpen , 2020, Belgium
Local Institution - 0016
Brussels , 1090, Belgium
Local Institution - 0038
Bruxelles , 1200, Belgium
Local Institution - 0044
Ottawa Ontario, K1H 8, Canada
Local Institution - 0048
Bordeaux , 33075, France
Local Institution - 0022
Lyon , 69008, France
Local Institution - 0021
Marseille Cedex 5 , 13385, France
Local Institution - 0020
Nantes , 44000, France
Local Institution - 0037
Erlangen , 91054, Germany
Local Institution - 0034
Essen , 45147, Germany
Local Institution - 0036
Gera , 07548, Germany
Local Institution - 0035
Hannover , 30625, Germany
Local Institution - 0033
Heidelberg , 69120, Germany
Local Institution - 0032
Lübeck , 23562, Germany
Local Institution - 0040
Nuremberg , 90419, Germany
Local Institution - 0026
Barcelona , 08035, Spain
Local Institution - 0030
Cordoba , 14004, Spain
Local Institution - 0027
Hospitalet de Llobregat - Barcelona , 08908, Spain
Local Institution - 0029
Madrid , 28034, Spain
Local Institution - 0031
San Sebastian , 20014, Spain
Local Institution - 0028
Valencia , 46009, Spain

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

215

Study ID:

NCT03978611

Recruitment Status:

Active, not recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.