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

NCT03459222

Description:

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

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

URL:

https://clinicaltrials.gov/show/NCT03459222

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: CA224-048
  • SECONDARY ID: 2018-000058-22
  • NCT ID: NCT03459222

Conditions

  • Advanced Cancer

Interventions

DrugSynonymsArms
RelatlimabBMS-986016Arm A
NivolumabOpdivo, BMS-936558Arm A
BMS-986205Arm A
IpilimumabYervoy, BMS-734016Arm B

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
Arm AExperimentalRelatlimab + Nivolumab + BMS-986205
  • Relatlimab
  • Nivolumab
  • BMS-986205
Arm BExperimentalRelatlimab + Nivolumab + Ipilimumab
  • Relatlimab
  • Nivolumab
  • Ipilimumab

Eligibility 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
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of clinical laboratory test abnormalities
Time Frame:approximately 4 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Progression Free Survival (PFS)
Time Frame:up to 4 years
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Bristol-Myers Squibb

Trial Keywords

  • immunotherapy
  • Relatlimab

Last Updated

October 22, 2020