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Antineoplastic Agents

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Pembrolizumab

Mogamulizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Pembrolizumab 400mg via IV over 30 minutes on Day 1 of each cycle (6 weeks) Mogamulizumab 1mg/kg via IV over a least 60 minutes Cycle 1: Days 1, 8, 15, and 22 Cycle 2+: Days 1, 15, and 29 Each cycle lasts 6 weeks with a maximum of 18 cycles If a subject achieves a complete response (CR) 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 they may discontinue study treatment and enter an observation period. Subjects who progress during the observation period may be eligible for up to an additional 12 cycles of pembrolizumab and mogamulizumab

Cancer AnswerLine

Ryan Wilcox, M.D.

Ryan Wilcox

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.

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

A Phase II Study of Pembrolizumab and Mogamulizumab in Advanced-stage, Relapsed/Refractory Cutaneous T-cell Lymphomas

Complete response (CR) rate at 6 months. CR is defined as percentage of patients who have a best response of CR at 6 months using mSWAT response criteria.

Best overall response (BOR) is defined as the best response recorded from the start of the treatment until progression/recurrence using mSWAT response criteria

Duration of response (DOR) is defined as time from first observed response (CR or PR) to date of progression (PD) or death, whichever occurs first using mSWAT response criteria

Time to next treatment (TTNT) is defined as time from Cycle 1 Day 1 to initiation of alternative systemic, antineoplastic therapy

Safety will be determined based on the frequency and severity of adverse events according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) v5. Specifically, grade 3-4 adverse events related to study treatment affecting 10% or more of subjects

Merck Sharp & Dohme LLC

Hoosier Cancer Research Network

University of Michigan Rogel Cancer Center

Spots Global Cancer Trial Database for fungoides mycosis sezary syndrome