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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 (CA224-048)
Protocol Number:
J1825
Phase:
Phase I/II
Physician:
Evan Lipson
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
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.
Eligibility:
Inclusion Criteria: 1) Histologic or cytologic confirmation of an incurable solid malignancy that is advanced (metastatic and/or unresectable), with measurable disease per RECIST v1.1; 2) Available tumor tissue for biomarker analysis; 3) Eastern Cooperative Oncology Group Performance Status (ECOG) status of 0 or 1.Exclusion Criteria: 1) Participants with known or suspected uncontrolled CNS metastases or with the CNS as the only site of active disease; 2) Participants with a history of interstitial lung disease (ILD) / pneumonitis 3) Prior malignancy active within the previous 3 years except for locally curable cancers that have been cured, such as basal or squamous cell skin cancerOther protocol defined inclusion/exclusion criteria could apply
Treatment:
Experimental: Arm A: Relatlimab + Nivolumab + BMS-986205Experimental: Arm B: Relatlimab + Nivolumab + Ipilimumab
Population:
Adult
Last Update
03/05/2019 05:03 AM