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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 : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE March 2, 2018
First Posted Date  ICMJE March 8, 2018
Last Update Posted Date January 27, 2020
Actual Study Start Date  ICMJE May 25, 2018
Estimated Primary Completion Date April 4, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 2, 2018)
  • Number of clinical laboratory test abnormalities [ Time Frame: approximately 4 years ]
  • Number of Adverse Events (AEs) [ Time Frame: approximately 4 years ]
  • Number of Serious Adverse Events (SAEs) [ Time Frame: approximately 4 years ]
  • Number of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria [ Time Frame: Up to 6 weeks ]
  • Number of AEs leading to discontinuation and deaths [ Time Frame: approximately 4 years ]
  • Objective Response Rate (ORR) [ Time Frame: approximately 4 years ]
  • Disease Control Rate (DCR) [ Time Frame: approximately 4 years ]
  • Median Duration of Response (mDOR) [ Time Frame: approximately 4 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2018)
Progression Free Survival (PFS) [ Time Frame: up to 4 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Investigational Study of Immunotherapy Combinations in Participants With Solid Cancers That Are Advanced or Have Spread
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Cancer
Intervention  ICMJE
  • 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
  • Biological: Ipilimumab
    Specified dose on specified days
    Other Names:
    • Yervoy
    • BMS-734016
Study Arms  ICMJE
  • Experimental: Arm A
    Relatlimab + Nivolumab + BMS-986205
    Interventions:
    • Biological: Relatlimab
    • Biological: Nivolumab
    • Drug: BMS-986205
  • Experimental: Arm B
    Relatlimab + Nivolumab + Ipilimumab
    Interventions:
    • Biological: Relatlimab
    • Biological: Nivolumab
    • Biological: Ipilimumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 2, 2018)
230
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 16, 2022
Estimated Primary Completion Date April 4, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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 #.
Listed Location Countries  ICMJE Australia,   France,   Italy,   Spain,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03459222
Other Study ID Numbers  ICMJE CA224-048
2018-000058-22 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP