Actively Recruiting
Pembrolizumab and Mogamulizumab in Advanced-stage, Relapsed/Refractory Cutaneous T-cell Lymphomas
Led by University of Michigan Rogel Cancer Center · Updated on 2026-05-05
23
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
Sponsors
U
University of Michigan Rogel Cancer Center
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pembrolizumab and Mogamulizumab in Advanced-stage, Relapsed/Refractory Cutaneous T-cell Lymphomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent and HIPAA authorization prior to registration
- Age 18 years or older at consent
- ECOG Performance Status of 0 or 1 within 7 days before first treatment
- Histological confirmation of cutaneous T-cell lymphoma (Mycosis Fungoides or Sezary Syndrome) with Stage IIB-IVB disease
- Measurable disease by Modified Severity Weighted Assessment Tool (mSWAT) within 30 days before treatment
- Have measurable, unirradiated disease; prior radiation >7 days before treatment start allowed
- Failed at least one prior systemic therapy, including extracorporeal photopheresis (ECP)
- Completed prior cancer treatments at least 28 days before first treatment and recovered from acute toxic effects
- Provide archival tissue or undergo a skin biopsy
- Use of systemic steroids under 10 mg/day prednisone equivalent is permitted; short steroid courses up to 7 days before registration allowed
- Adequate organ function based on blood tests within 28 days prior to treatment
- Negative pregnancy test for females of childbearing potential within 72 hours prior to registration
- Willingness to use effective contraception or abstain from heterosexual intercourse if of childbearing potential
- CNS disease patients eligible if other criteria met
- Life expectancy of at least 6 months
- Ability to understand and comply with study procedures for entire study duration
You will not qualify if you...
- Known HIV infection
- Active hepatitis B or C infection
- Previous treatment with pembrolizumab, mogamulizumab, or other checkpoint inhibitors
- Radiation therapy within 7 days before first treatment
- Immunodeficiency or chronic systemic steroids over 10 mg/day prednisone equivalent within 7 days before treatment
- Active or prior autoimmune disease needing systemic treatment in past 2 years (except vitiligo or alopecia)
- History or current pneumonitis/interstitial lung disease requiring steroids
- Additional active malignancy requiring treatment within past 2 years (excluding certain skin cancers)
- Active infection needing systemic therapy
- Prior allogeneic stem cell or cellular transplant, recent immunosuppressive therapy
- Prior solid organ transplant
- Pregnant or breastfeeding
- Severe hypersensitivity to pembrolizumab or mogamulizumab
- Use of investigational drugs or devices within 30 days before registration
- Live or live-attenuated vaccine within 30 days before first dose
- Psychiatric or substance abuse disorders interfering with study participation
- Any condition or therapy that may confound study results or affect participation, per investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
C
Cancer AnswerLine
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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