Phase II Study of Pembrolizumab and Mogamulizumab for Advanced, Relapsed or Refractory Cutaneous T-cell Lymphomas

What this Trial Is About

Researchers are evaluating the combination of pembrolizumab and mogamulizumab in patients with advanced-stage, relapsed or refractory cutaneous T-cell lymphoma CTCL, including Mycosis Fungoides and Sezary Syndrome. This phase II, open-label, single-arm study aims to assess the complete response rate and other outcomes in patients who have failed at least one prior systemic therapy. The study is sponsored by the University of Michigan Rogel Cancer Center and focuses on patients with measurable disease and adequate organ function. Participants will receive pembrolizumab 400 mg intravenously on Day 1 of each 6-week cycle. Mogamulizumab will be given intravenously at 1 mgkg with a specific schedule during Cycle 1, on Days 1, 8, 15, and 22, and from Cycle 2 onward, on Days 1, 15, and 29 of each cycle. Treatment may continue for up to 2 years or until disease progression or unacceptable toxicity. If a complete response is achieved after 3 months 2 cycles, treatment continues for 6 more months 4 cycles, after which participants may stop therapy and enter an observation period. Those who progress during observation may receive up to an additional year of treatment. During the study, participants will undergo response assessments before Cycle 3 and every two cycles thereafter using the Modified Severity Weighted Assessment Tool mSWAT. Researchers will monitor disease status, adverse events, and overall response for up to 2 years. Safety labs and pregnancy tests are required before starting treatment. Participants will be followed closely to evaluate treatment effects, duration of response, time to next treatment, and overall safety throughout the trial and observation period.

Pembrolizumab and Mogamulizumab in Advanced-stage, Relapsed/Refractory Cutaneous T-cell Lymphomas