Back to resultsA 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
Primary Purpose
Melanoma
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Relatlimab
Ipilimumab
Sponsored by
About this trial
This is an interventional treatment trial for Melanoma
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
Sites / Locations
- Local Institution - 0023
- Local Institution - 0002
- Local Institution - 0005
- Local Institution - 0001
- Local Institution - 0015
- Local Institution - 0004
- Local Institution - 0003
- Local Institution - 0008
- Local Institution - 0018
- Local Institution - 0017
- Local Institution - 0016
- Local Institution - 0038
- Local Institution - 0044
- Local Institution - 0037
- Local Institution - 0034
- Local Institution - 0036
- Local Institution - 0035
- Local Institution - 0033
- Local Institution - 0032
- Local Institution - 0040
- Local Institution - 0026
- Local Institution - 0030
- Local Institution - 0027
- Local Institution - 0029
- Local Institution - 0031
- Local Institution - 0028
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Part 1: Dose Escalation Phase
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants with Adverse Events (AEs)
Number of Participants with Serious Adverse Events (SAEs)
Number of Participants With Adverse Events Including Dose Limiting Toxicity
Number of Participants with AEs resulting in Discontinuation
Number of Participants with AEs resulting in Death
Number of Participants with AEs resulting in Laboratory Abnormalities
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03978611
Brief Title
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
Official Title
A Phase 1/2a Study to Evaluate the Safety, Tolerability, and Efficacy of Relatlimab Administered in Combination With Ipilimumab or Ipilimumab Alone in Participants With Unresectable or Metastatic Melanoma Who Have Progressed on Anti-PD-1 Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
December 9, 2021 (Actual)
Primary Completion Date
July 26, 2023 (Actual)
Study Completion Date
July 26, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Part 1: Dose Escalation Phase
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Relatlimab
Other Intervention Name(s)
BMS-986016
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Ipilimumab
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events (AEs)
Time Frame
Up to Follow-up Period (100 days after 34 cycles [1 cycle is of 3 weeks])
Title
Number of Participants with Serious Adverse Events (SAEs)
Time Frame
Up to Follow-up Period (100 days after 34 cycles [1 cycle is of 3 weeks])
Title
Number of Participants With Adverse Events Including Dose Limiting Toxicity
Time Frame
Up to 28 days after last study drug dose (approximately up to 2 years)
Title
Number of Participants with AEs resulting in Discontinuation
Time Frame
Up to end of study (approximately 2.4 years)
Title
Number of Participants with AEs resulting in Death
Time Frame
Up to end of study (approximately 2.4 years)
Title
Number of Participants with AEs resulting in Laboratory Abnormalities
Time Frame
Up to end of study (approximately 2.4 years)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution - 0023
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Local Institution - 0002
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Local Institution - 0005
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Local Institution - 0001
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Local Institution - 0015
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Local Institution - 0004
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Local Institution - 0003
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Local Institution - 0008
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Local Institution - 0018
City
Bruxelles
State/Province
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Local Institution - 0017
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
Facility Name
Local Institution - 0016
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Local Institution - 0038
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Local Institution - 0044
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Local Institution - 0037
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Local Institution - 0034
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Local Institution - 0036
City
Gera
ZIP/Postal Code
07548
Country
Germany
Facility Name
Local Institution - 0035
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Local Institution - 0033
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Local Institution - 0032
City
Lübeck
ZIP/Postal Code
23562
Country
Germany
Facility Name
Local Institution - 0040
City
Nuremberg
ZIP/Postal Code
90419
Country
Germany
Facility Name
Local Institution - 0026
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Local Institution - 0030
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Local Institution - 0027
City
Hospitalet de Llobregat - Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Local Institution - 0029
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Local Institution - 0031
City
San Sebastian
ZIP/Postal Code
20014
Country
Spain
Facility Name
Local Institution - 0028
City
Valencia
ZIP/Postal Code
46009
Country
Spain
12. IPD Sharing Statement
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
http://www.fda.gov/safety/medwatch/safetyinformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
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
We'll reach out to this number within 24 hrs