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

NCT03978611 | Terminated Phase 1 FDA Drug

• 2 other identifiers: CA224-0832019-000132-25
• Study Type: interventional
• Target: 11
• Locations: 6 countries
• Sites: 28

Brief Summary

The primary purpose of this study is to characterize the safety, tolerability, and dose-limiting toxicities (DLTs) of relatlimab in combination with ipilimumab.

Conditions

Melanoma

Outcome Measures

Primary Outcomes (6)

• Number of Participants with Adverse Events (AEs)

  Up to Follow-up Period (100 days after 34 cycles [1 cycle is of 3 weeks])

• Number of Participants with Serious Adverse Events (SAEs)

  Up to Follow-up Period (100 days after 34 cycles [1 cycle is of 3 weeks])

• Number of Participants With Adverse Events Including Dose Limiting Toxicity

  Up to 28 days after last study drug dose (approximately up to 2 years)

• Number of Participants with AEs resulting in Discontinuation

  Up to end of study (approximately 2.4 years)

• Number of Participants with AEs resulting in Death

  Up to end of study (approximately 2.4 years)

• Number of Participants with AEs resulting in Laboratory Abnormalities

  Up to end of study (approximately 2.4 years)

Study Arms (1)

Part 1: Dose Escalation Phase

EXPERIMENTAL

Drug: Relatlimab; Drug: Ipilimumab

Interventions

Relatlimab DRUG

Specified dose on specified days

Also known as: BMS-986016

Part 1: Dose Escalation Phase

Ipilimumab DRUG

Specified dose on specified days

Part 1: Dose Escalation Phase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (28)

Local Institution - 0023

Tucson, Arizona, 85724, United States

Location

Local Institution - 0002

Los Angeles, California, 90033, United States

Location

Local Institution - 0005

Los Angeles, California, 90033, United States

Location

Local Institution - 0001

Santa Monica, California, 90404, United States

Location

Local Institution - 0015

Miami, Florida, 33136, United States

Location

Local Institution - 0004

Chicago, Illinois, 60611, United States

Location

Local Institution - 0003

Ann Arbor, Michigan, 48109, United States

Location

Local Institution - 0008

Morristown, New Jersey, 07960, United States

Location

Local Institution - 0018

Brussels, Brussels Capital, 1000, Belgium

Location

Local Institution - 0017

Antwerp, 2020, Belgium

Location

Local Institution - 0016

Brussels, 1090, Belgium

Location

Local Institution - 0038

Brussels, 1200, Belgium

Location

Local Institution - 0044

Ottawa, Ontario, K1H 8L6, Canada

Location

Local Institution - 0037

Erlangen, 91054, Germany

Location

Local Institution - 0034

Essen, 45147, Germany

Location

Local Institution - 0036

Gera, 07548, Germany

Location

Local Institution - 0035

Hanover, 30625, Germany

Location

Local Institution - 0033

Heidelberg, 69120, Germany

Location

Local Institution - 0032

Lübeck, 23562, Germany

Location

Local Institution - 0040

Nuremberg, 90419, Germany

Location

Local Institution - 0053

Padua, 35128, Italy

Location

Local Institution - 0055

Siena, 53100, Italy

Location

Local Institution - 0026

Barcelona, 08035, Spain

Location

Local Institution - 0030

Córdoba, 14004, Spain

Location

Local Institution - 0031

Donostia / San Sebastian, 20014, Spain

Location

Local Institution - 0027

Hospitalet de Llobregat - Barcelona, 08908, Spain

Location

Local Institution - 0029

Madrid, 28034, Spain

Location

Local Institution - 0028

Valencia, 46009, Spain

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Melanoma

Interventions

relatlimab; Ipilimumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: June 7, 2019
• Study Start: December 9, 2021
• Primary Completion: July 26, 2023
• Study Completion: July 26, 2023
• Last Updated: July 24, 2024

Record last verified: 2024-07

Locations

US (8); DE (7); ES (6); IT (2); BE (4); CA (1)