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Monoclonal Antibodies

Pembrolizumab + Mogamulizumab for Cutaneous T-Cell Lymphoma

Phase 2
Recruiting
Led By Ryan Wilcox
Research Sponsored by University of Michigan Rogel Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is combining two drugs for advanced-stage CTCL, each cycle lasting 6 weeks. Patients will be evaluated regularly and get up to 2 years of treatment if necessary. If a complete response is achieved after 2 cycles, treatment will be continued for an additional 6 months.

Who is the study for?
Adults with advanced-stage, relapsed/refractory Cutaneous T-cell Lymphoma (CTCL) who have failed at least one systemic therapy can join. They must have measurable disease not treated by radiation within the last week, be expected to live more than 6 months, and function relatively well daily. Participants need proper organ function and women of childbearing age must test negative for pregnancy and agree to contraception.
What is being tested?
The trial tests a combination of two drugs: Pembrolizumab and Mogamulizumab in patients with CTCL. It's an open-label phase II study where everyone gets both drugs in cycles lasting six weeks. Responses are checked before cycle three and every two cycles after that. Treatment continues unless there's progression or unacceptable side effects for up to two years.
What are the potential side effects?
Possible side effects include reactions at the infusion site, fatigue, nausea, immune-related issues like inflammation in organs or skin rashes, blood disorders such as low counts leading to increased infection risk or bleeding problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Complete Response Rate
Secondary study objectives
Assess Adverse Events
Best overall Response (BOR)
Duration of response (DOR)
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: ExperimentalExperimental Treatment2 Interventions
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~3150
Mogamulizumab
2016
Completed Phase 2
~70

Find a Location

Who is running the clinical trial?

University of Michigan Rogel Cancer CenterLead Sponsor
300 Previous Clinical Trials
24,342 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
4,012 Previous Clinical Trials
5,185,394 Total Patients Enrolled
Hoosier Cancer Research NetworkOTHER
68 Previous Clinical Trials
3,733 Total Patients Enrolled

Media Library

Mogamulizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05956041 — Phase 2
Cutaneous T-Cell Lymphoma Research Study Groups: Experimental
Cutaneous T-Cell Lymphoma Clinical Trial 2023: Mogamulizumab Highlights & Side Effects. Trial Name: NCT05956041 — Phase 2
Mogamulizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05956041 — Phase 2
~12 spots leftby Dec 2025