Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

An Investigational Study of Immunotherapy Combinations in Participants With Solid Cancers That Are Advanced or Have Spread

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03459222
Recruitment Status : Recruiting
First Posted : March 8, 2018
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to investigate safety and anti-tumor activity of relatlimab combination therapy in solid cancers that are advanced or have spread

Condition or disease Intervention/treatment Phase
Advanced Cancer Biological: Relatlimab Biological: Nivolumab Drug: BMS-986205 Biological: Ipilimumab Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 25, 2018
Estimated Primary Completion Date : April 4, 2022
Estimated Study Completion Date : May 16, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm A
Relatlimab + Nivolumab + BMS-986205
Biological: Relatlimab
Specified dose on specified days
Other Name: BMS-986016

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558

Drug: BMS-986205
Specified dose on specified days

Experimental: Arm B
Relatlimab + Nivolumab + Ipilimumab
Biological: Relatlimab
Specified dose on specified days
Other Name: BMS-986016

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558

Biological: Ipilimumab
Specified dose on specified days
Other Names:
  • Yervoy
  • BMS-734016




Primary Outcome Measures :
  1. Number of clinical laboratory test abnormalities [ Time Frame: approximately 4 years ]
  2. Number of Adverse Events (AEs) [ Time Frame: approximately 4 years ]
  3. Number of Serious Adverse Events (SAEs) [ Time Frame: approximately 4 years ]
  4. Number of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria [ Time Frame: Up to 6 weeks ]
  5. Number of AEs leading to discontinuation and deaths [ Time Frame: approximately 4 years ]
  6. Objective Response Rate (ORR) [ Time Frame: approximately 4 years ]
  7. Disease Control Rate (DCR) [ Time Frame: approximately 4 years ]
  8. Median Duration of Response (mDOR) [ Time Frame: approximately 4 years ]

Secondary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: up to 4 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Histologic or cytologic confirmation of an incurable solid malignancy that is 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:

  • Participants with known or suspected uncontrolled CNS metastases or with the CNS as the only site of active disease
  • Participants with a history of interstitial lung disease (ILD) / pneumonitis
  • Prior malignancy active within the previous 3 years except for locally curable cancers that have been cured, such as basal or squamous cell skin cancer

Other protocol defined inclusion/exclusion criteria could apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03459222


Contacts
Layout table for location contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

Locations
Layout table for location information
United States, California
City of Hope National Medical Center Recruiting
Duarte, California, United States, 91010
Contact: Karen Reckamp, Site 0006         
United States, Colorado
University Of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Antonio Jimeno, Site 0003         
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21287
Contact: Evan Lipson, Site 0004         
United States, Missouri
Washington University School Of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: George Ansstas, Site 0005         
United States, Tennessee
The West Clinic, P.C. Recruiting
Germantown, Tennessee, United States, 38138
Contact: Ari Vanderwalde, Site 0001         
United States, Washington
Local Institution Not yet recruiting
Seattle, Washington, United States, 98109-1023
Contact: Site 0002         
Australia, New South Wales
Melanoma Institute Australia Recruiting
North Sydney, New South Wales, Australia, 2060
Contact: Georgina Long, Site 0012    +61299117200      
Australia, Western Australia
Linear Clinical Research Ltd Recruiting
Nedlands, Western Australia, Australia, 6009
Contact: Samantha Bowyer, Site 0011    +61863825115      
France
Local Institution Not yet recruiting
Marseille Cedex 5, France, 13385
Contact: Site 0017         
Local Institution Not yet recruiting
Toulouse, France, 31100
Contact: Site 0016         
Local Institution Not yet recruiting
Villejuif, France, 94800
Contact: Site 0015         
Italy
Istituto Nazionale Tumori Fondazione Pascale Recruiting
Napoli, Italy, 80131
Contact: Paolo Ascierto, Site 0009    +390815903841 000 0000000      
Spain
Local Institution Not yet recruiting
Barcelona, Spain, 08036
Contact: Site 0019         
Local Institution Not yet recruiting
Madrid, Spain, 28050
Contact: Site 0018         
Local Institution Not yet recruiting
Pamplona, Spain, 31008
Contact: Site 0020         
Switzerland
Chu Vaudois Lausanne Recruiting
Lausanne, Switzerland, 1011
Contact: Stefan Zimmermann, Site 0008    +41264267243      
Universitaetsspital Zuerich Recruiting
Zurich, Switzerland, 8091
Contact: Reinhard Dummer, Site 0007    +41442559485      
United Kingdom
Local Institution Not yet recruiting
Newcastle Upon Tyne, United Kingdom, NE7 7DN
Contact: Site 0014         
Local Institution Recruiting
Oxford, United Kingdom, OX3 7LE
Contact: Site 0013         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Layout table for investigator information
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03459222     History of Changes
Other Study ID Numbers: CA224-048
2018-000058-22 ( EudraCT Number )
First Posted: March 8, 2018    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bristol-Myers Squibb:
immunotherapy
Relatlimab

Additional relevant MeSH terms:
Layout table for MeSH terms
Nivolumab
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents