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Safety Study of Anti-LAG-3 With and Without Anti-PD-1 in the Treatment of Solid Tumors

Status: Recruiting
Phase: Phase 1
Diagnosis: Solid Tumor/Phase I
NCT ID: NCT01968109 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID:

 

To assess the safety and tolerability, characterize the dose-limiting toxicities, and identify the maximum tolerated dose of BMS-986016 alone and in combination with Nivolumab in subjects with select advanced (metastatic and/or unresectable) solid tumors and to provide preliminary information on the clinical benefits of the combination.

 

Conducting Institutions:
Brigham and Women's Hospital, Dana-Farber Cancer Institute

Overall PI:
Frank Stephen Hodi, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Contacts:
Dana-Farber Cancer Institute: Andrew Wolanski, 617-632-6623, andrew_wolanski@dfci.harvard.edu

Eligibility Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: - Part A, Dose Escalation: Advanced (metastatic and/or unresectable) and incurable solid tumors - Part B, Dose Escalation: Advanced (metastatic and/or unresectable) and incurable solid tumors, with or without most recent therapy being anti-PD-1 or anti-programmed cell death protein ligand 1 (anti-PD-L1). Subjects with anti-PD-1 or anti-PDL-1 therapy must have been unresponsive and progressed within 16 weeks of starting therapy - Part C Cohort Expansion: Advanced (metastatic and/or unresectable) and incurable melanoma (with or without the last therapy being anti-PD-1 or anti-PD-L1); non-small cell lung cancer (NSCLC) (with or without the last therapy being anti-PD-1 or anti-PD-L1) (melanoma and NSCLC subjects with anti-PD-1 or anti-PDL-1 therapy must have been unresponsive and progressed within 16 weeks of starting therapy); human papilloma virus (HPV) positive head and neck squamous cell carcinomas; or gastric adenocarcinoma - Part A: Progressed, or been intolerant to, at least one standard treatment regimen in the advanced or metastatic setting (if such a therapy exists) - Part B or C: Progressed, or been intolerant to, at least one standard treatment regimen or refuse standard treatment in the advanced or metastatic setting (if such therapy exists) - Received less than 5 prior treatment regimens - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - At least 1 lesion with measurable disease at baseline - Availability of an existing tumor biopsy sample (or consent to allow pre-treatment tumor biopsy if sample not available) Exclusion Criteria: - Primary central nervous system (CNS) tumors or solid tumors with CNS metastases as the only site of active disease - Uncontrolled CNS metastases - Any prior exposure to immune cell modulating antibody regimens except as described in inclusion criteria for Part B subjects or specific Part C subjects - Autoimmune disease - Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent
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