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Clinical Trial Details

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Brief Title Study of MK-3475 in Relapsed or Refractory Peripheral T-cell Non-Hodgkin Lymphoma
Official Title A Phase II Study to Determine Feasibility and Safety of Single Agent MK-3475 in Relapsed or Refractory Peripheral T-cell Non-Hodgkin Lymphoma
Principal Investigator Smith, Sonali
Brief Summary This is a multicenter, single-arm, open label 2-stage phase 2 study exploring monotherapy with the PD-1 antibody pembrolizumab (or MK-3475) given intravenously at a fixed dose of 200mg every 3 weeks for up to 36 cycles for patients with relapsed or refractory Peripheral T-cell Lymphoma (PTCL), who have received at least 1 prior systemic therapy. The primary endpoint of the study is progression-free survival. Secondary outcomes are overall survival and response rate. Patients will be assessed for response with PET CT or CT every 12 weeks using the revised Cheson criteria. Correlative endpoints will be exploratory and assess PD-1 expression on peripheral blood lymphocytes; peripheral blood T-cell and NK-cell functional assays; PD-1 and PD-L1 expression on tumor tissue; and tumor infiltrating lymphocytes as prognostic and predictive biomarkers.
Gender Both
Ages 18 Years
Enrollment 24
Accepts Healthy Volunteers No
Lead Sponsor Fox Chase Cancer CenterOther
Collaborator Merck Sharp & Dohme Corp.Industry
Study Design Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Phase Phase 2
Study Type Interventional
Contact Name Stefan K. Barta, MD
Contact Phone 1-855-702-8222 (adult trials) or 1-773-702-6808 (pediatric trials)
Condition Lymphoma, T-Cell, Peripheral
Detail for Health Professional (on clinicaltrials.gov)
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