Pembrolizumab and Mogamulizumab in Advanced-stage, Relapsed/Refractory Cutaneous T-cell Lymphomas
Status:
Recruiting
Trial end date:
2026-12-01
Target enrollment:
Participant gender:
Summary
This is an open-label, single-arm, multicenter, phase II study combining pembrolizumab and
mogamulizumab in patients with advanced-stage, relapsed or refractory CTCL Each cycle will
equal 6 weeks. Pembrolizumab will be administered on Day 1 of each cycle. Mogamulizumab will
be administered on Day 1, 8, 15, and 22 of Cycle 1. For Cycle 2 and subsequent cycles,
mogamulizumab will be administered on Day 1, 15 and 29 of each cycle. Subjects will undergo a
response assessment prior to Cycle 3 and every 2 cycles thereafter.
Subjects will continue study treatment until documented progression, unacceptable toxicity,
or any other condition for discontinuation is met in protocol. A maximum of 2 years of study
treatment may be administered. If a subject achieves a complete response (CR) per mSWAT
criteria after 3 months of study treatment (2 cycles), they will continue study therapy for
an additional 6 months (4 cycles). If a confirmed and persistent CR is met, they may
discontinue study treatment and enter an observation period in protocol. Repeat disease
evaluation is required prior to study therapy discontinuation. Subjects who progress during
the observation period may be eligible for up to an additional 9 cycles (1 year) of
pembrolizumab and mogamulizumab.
Phase:
Phase 2
Details
Lead Sponsor:
University of Michigan Rogel Cancer Center
Collaborators:
Hoosier Cancer Research Network Merck Sharp & Dohme LLC