- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03459222
An Investigational Study of Immunotherapy Combinations in Participants With Solid Cancers That Are Advanced or Have Spread
September 14, 2023 updated by: Bristol-Myers Squibb
A Phase 1/2 Study of Relatlimab (Anti-LAG-3 Monoclonal Antibody) Administered in Combination With Both Nivolumab (Anti-PD-1 Monoclonal Antibody) and BMS-986205 (IDO1 Inhibitor) or in Combination With Both Nivolumab and Ipilimumab (Anti-CTLA-4 Monoclonal Antibody) in Advanced Malignant Tumors
The purpose of this study is to demonstrate the safety and preliminary activity with triple combinations of relatlimab in combination with nivolumab and BMS-986205, or in combination with nivolumab and ipilimumab in immunotherapy-naive and pretreated populations across select advanced tumor types.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
255
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New South Wales
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Wollstonecraft, New South Wales, Australia, 2065
- Local Institution - 0012
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Western Australia
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Nedlands, Western Australia, Australia, 6009
- Local Institution - 0011
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Marseille Cedex 5, France, 13385
- Hopital de La Timone
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Toulouse Cedex 9, France, 31059
- Institut Claudius Regaud
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Villejuif, France, 94800
- Institute Gustave Roussy
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Forlì, Italy, 47014
- Local Institution - 0010
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Napoli, Italy, 80131
- Local Institution - 0009
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Rome, Italy, 00144
- Local Institution - 0023
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Barcelona, Spain, 08036
- Local Institution - 0019
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Madrid, Spain, 28041
- Local Institution - 0021
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Madrid, Spain, 28050
- Local Institution - 0018
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Málaga, Spain, 29011
- Local Institution - 0022
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Pamplona, Spain, 31008
- Local Institution - 0020
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Lausanne, Switzerland, 1011
- Local Institution - 0008
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Zuerich, Switzerland, 8091
- Local Institution - 0007
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Headington, United Kingdom, OX3 7LE
- Local Institution - 0013
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Newcastle Upon Tyne, United Kingdom, NE7 7DN
- Local Institution - 0014
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California
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Duarte, California, United States, 91010
- Local Institution - 0006
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Colorado
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Aurora, Colorado, United States, 80045
- Local Institution - 0003
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Maryland
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Baltimore, Maryland, United States, 21231
- Local Institution - 0004
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Missouri
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Saint Louis, Missouri, United States, 63110
- Local Institution - 0005
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Ohio
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Cleveland, Ohio, United States, 44106
- Local Institution
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Tennessee
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Germantown, Tennessee, United States, 38138
- Local Institution - 0001
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Histologic or cytologic confirmation of select incurable solid malignancies that are advanced (metastatic and/or unresectable), with measurable disease per RECIST v1.1
- Available tumor tissue for biomarker analysis
- Eastern Cooperative Oncology Group Performance Status (ECOG) status of 0 or 1
Exclusion Criteria:
- Known or suspected central nervous system (CNS) metastases or with the CNS as the only site of active disease
- History of interstitial lung disease / pneumonitis
- Prior malignancy active within the previous 2 years except for locally curable cancers that have been cured, such as basal or squamous cell skin cancer
- Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent
Other protocol-defined inclusion/exclusion criteria apply
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm A
Relatlimab + Nivolumab + BMS-986205
|
Specified dose on specified days
Other Names:
Specified dose on specified days
Other Names:
Specified dose on specified days
Other Names:
|
Experimental: Arm B
Relatlimab + Nivolumab + Ipilimumab
|
Specified dose on specified days
Other Names:
Specified dose on specified days
Other Names:
Specified dose on specified days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of clinical laboratory test abnormalities
Time Frame: Approximately 4 years
|
Approximately 4 years
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Number of Adverse Events (AEs)
Time Frame: Approximately 4 years
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Approximately 4 years
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Number of Serious Adverse Events (SAEs)
Time Frame: Approximately 4 years
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Approximately 4 years
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Number of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria
Time Frame: Up to 6 weeks
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Up to 6 weeks
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Number of AEs leading to discontinuation
Time Frame: Approximately 4 years
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Approximately 4 years
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Number of AEs leading to death
Time Frame: Approximately 4 years
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Approximately 4 years
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Objective Response Rate (ORR)
Time Frame: Approximately 4 years
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Approximately 4 years
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Disease Control Rate (DCR)
Time Frame: Approximately 4 years
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Approximately 4 years
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Median Duration of Response (mDOR)
Time Frame: Approximately 4 years
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Approximately 4 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression-Free Survival (PFS)
Time Frame: Up to 4 years
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Up to 4 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 30, 2018
Primary Completion (Estimated)
April 22, 2024
Study Completion (Estimated)
November 10, 2026
Study Registration Dates
First Submitted
March 2, 2018
First Submitted That Met QC Criteria
March 2, 2018
First Posted (Actual)
March 8, 2018
Study Record Updates
Last Update Posted (Actual)
September 18, 2023
Last Update Submitted That Met QC Criteria
September 14, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CA224-048
- 2018-000058-22 (EudraCT Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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