MK-3475, Relapsed, Refractory, Phase 2, Clinical Trials

Study of MK-3475 in Relapsed or Refractory Peripheral T-cell Non-Hodgkin Lymphoma

This study has been temporarily suspended for interim analyses.

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.

Study Type:  Interventional

Study Design:  

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

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

Condition:  Lymphoma, T-Cell, Peripheral

Interventions:  Drug: MK-3475

Phase:  Phase 2

External Link:  https://clinicaltrials.gov/ct2/show/NCT02535247