Actively Recruiting
A Phase II Study of 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
52 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
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 mg/kg 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.
CONDITIONS
Brief 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 before registration.
- Be 18 years of age or older at the time of consent.
- Have an ECOG Performance Status of 0 or 1 within 7 days before starting treatment.
- Have a confirmed diagnosis of cutaneous T-cell lymphoma (Mycosis Fungoides or Sezary Syndrome) at Stage IIB to IVB.
- Have measurable disease by the Modified Severity Weighted Assessment Tool (mSWAT) within 30 days before treatment.
- Have measurable, unirradiated disease; prior radiation allowed if completed more than 7 days before treatment.
- Have failed at least one prior systemic therapy, including extracorporeal photopheresis (ECP).
- Completed prior cancer treatment at least 28 days before treatment and recovered from acute toxic effects.
- Provide archival tissue or undergo a skin biopsy if no archival tissue is available.
- Have adequate organ function based on specific blood and liver tests within 28 days before treatment.
- Females of childbearing potential must have a negative pregnancy test within 72 hours before registration.
- Agree to use effective contraception or abstain from heterosexual intercourse during the study.
- Have a life expectancy of at least 6 months.
- Be able to understand and comply with study procedures for the entire study duration.
You will not qualify if you...
- Known history of HIV infection.
- Active Hepatitis B or C infection.
- Prior treatment with pembrolizumab, mogamulizumab, or other checkpoint inhibitors.
- Radiation therapy within 7 days before starting treatment.
- Immunodeficiency or chronic systemic steroid use exceeding 10 mg/day prednisone equivalent within 7 days before treatment.
- Active or recent autoimmune disease requiring systemic treatment within the past 2 years (except vitiligo or alopecia).
- History or current pneumonitis or interstitial lung disease requiring steroids.
- Additional progressing malignancy requiring treatment within the past 2 years (non-melanoma skin cancers excluded).
- Active infection requiring systemic therapy.
- Prior allogeneic stem cell or organ transplant.
- Pregnant or breastfeeding.
- Severe hypersensitivity to pembrolizumab, mogamulizumab, or their components.
- Use of investigational drugs or devices within 30 days before registration.
- Receipt of live or live-attenuated vaccines within 30 days before treatment.
- Psychiatric or substance abuse disorders interfering with trial participation.
- Any condition or treatment that may confound study results or interfere with participation, as judged by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 18 cycles of 6 weeks each
Participants receive pembrolizumab and mogamulizumab intravenously in cycles lasting 6 weeks each, with a maximum of 18 cycles. Treatment includes pembrolizumab 400mg on Day 1 of each cycle, and mogamulizumab 1mg/kg administered multiple times per cycle.
Multiple visits with pembrolizumab on Day 1 of each cycle and mogamulizumab on Days 1, 8, 15, and 22 in Cycle 1, then Days 1, 15, and 29 in subsequent cycles
Duration - Up to 2 years for response and safety monitoring
Participants who achieve a complete response after initial treatment may discontinue therapy and enter an observation period; those who progress during observation may receive additional treatment cycles.
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here