Cutaneous T Cell LymphomaPhase 2NCT05956041
Pembrolizumab and Mogamulizumab in Advanced-stage, Relapsed/Refractory Cutaneous T-cell Lymphomas
A Phase 2 study testing Pembrolizumab and Mogamulizumab in people with Cutaneous T Cell Lymphoma and Fungoides Mycosis Sezary Syndrome, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous T Cell Lymphoma, Fungoides Mycosis Sezary Syndrome
- What is being tested?
- Pembrolizumab and Mogamulizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2023to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Age ≥ 18 years at the time of consent.
- ECOG Performance Status of ≤ 1 within 7 days prior to Cycle 1 Day 1 treatment.
- Histological confirmation of cutaneous T-cell lymphoma (Mycosis Fungoides/Sezary Syndrome) with Stage IIB-IVB disease (TNMB Classification).
- Measurable disease according to Modified Severity Weighted Assessment Tool (mSWAT) within 30 days prior to treatment.
- Patients must have measurable, unirradiated disease. Prior disease radiation, if greater than 7 days prior to C1D1, is acceptable (see protocol). However, patient must have measurable disease that has not been radiated.
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- Patients must have failed at least one prior line of systemic therapy. This includes ECP. Prior cancer treatment must be completed at least 28 days prior to Cycle 1 Day 1(C1D1) and the subject must have recovered from all reversible acute toxic effects of the regimen (other than alopecia) to ≤ grade 1 or baseline.
- Archival tissue is required and will be identified at screening and shipped prior to C1D1 (10-15 unstained slides; obtained within 90 days of registration). Subjects that do not have archival tissue will be required to undergo a skin biopsy.
- Systemic steroids at a dose less than the equivalent of 10 mg/day of prednisone and inhaled, nasal, and topical steroids are permitted. Adrenal replacement steroid doses > 10 mg daily prednisone equivalent in the absence of active autoimmune disease are permitted. Treatment with a short course of steroids (< 5 days) up to 7 days prior to study registration is permitted.
- Demonstrate adequate organ function as defined below. All screening labs to be obtained within 28 days prior to Cycle 1 Day 1.
- Hematological
- Absolute Neutrophil Count (ANC) ≥ 500/µL
- Hemoglobin (Hgb) ≥ 8 g/dL
- Platelet Count ≥ 25 000/µL
- Renal
- ---Creatinine OR Measured or calculated creatinine clearance1 ≤ 1.5 × ULN OR
- ≥ 30 mL/min for participant with creatinine levels > 1.5 × institutional ULN
- Hepatic
- Bilirubin ≤ 1.5 ×ULN OR direct bilirubin ≤ ULN for participants with total bilirubin levels > 1.5 × ULN
- Aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN for participants with liver metastases)
- Alanine aminotransferase (ALT) ≤ 2.5 × ULN (≤ 5 × ULN for participants with liver metastases)
- Coagulation ---International Normalized Ratio (INR) or Prothrombin Time (PT) Activated Partial Thromboplastin Time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
- Females of childbearing potential must have a negative serum pregnancy test within 72 hours prior to registration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. See protocol for definition of childbearing potential.
- Females of childbearing potential must be willing to abstain from heterosexual intercourse or to use an effective method(s) of contraception as outlined in protocol. Males must be willing to abstain from heterosexual intercourse or to use an effective method(s) of contraception as outlined in protocol.
- Subjects with CNS disease are eligible so long as they meet all other eligibility criteria.
- Patients must have a life expectancy of at least 6 months.
- As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.
Who cannot join
- Patients with a known history of Human Immunodeficiency Virus (HIV) infection are excluded. NOTE: No HIV testing is required unless mandated by local health authority.
- Patients with concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV DNA) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection. NOTE: Hepatitis B and C screening tests are not required unless: (1) Known history of HBV and HCV infection or (2) As mandated by local health authority.
- Patients previously treated with checkpoint blockade, including pembrolizumab, or mogamulizumab, are excluded.
- Patients who have received disease radiation therapy within 7 days of C1D1.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to Cycle 1 Day 1. Systemic steroids at a dose less than the equivalent of 10 mg/day of prednisone and inhaled, nasal, and topical steroids are permitted as detailed in protocol.
- Has active or prior autoimmune disease or inflammatory disorders that have required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs) with teh exception of vitiligo or alopecia. Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.
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- Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- Known additional malignancy that is progressing or has required active treatment within the past 2 years. NOTE: patients with non-melanoma skin cancers and in situ cancers that do not require systemic therapies are eligible.
- Active infection requiring systemic therapy.
- Prior allogeneic stem cell transplant or allogeneic cellular therapies, recent immunosuppressive therapies (for any reason).
- Prior solid organ transplant.
- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
- Has severe hypersensitivity (≥Grade 3) to pembrolizumab or mogamulizumab and/or any of their excipients.
- Treatment with any investigational drug or investigation device within 30 days prior to registration.
- Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines and mRNA or inactivated COVID-19 vaccine is allowed.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
Ryan Wilcox, M.D., 734-615-1482, rywilcox@umich.edu
Jonathon Weiss, M.D.
About this study
Official title: A Phase II Study of Pembrolizumab and Mogamulizumab in Advanced-stage, Relapsed/Refractory Cutaneous T-cell Lymphomas
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.
- Being tested
- Pembrolizumab, Mogamulizumab
- Medical subject headings
- Lymphoma, T-Cell, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Also called Keytruda
400mg Intravenously
MogamulizumabDrug
Also called Poteligeo
1mg/kg Intravenously
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | 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 Receives: Drug: Pembrolizumab; Drug: Mogamulizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response Rate
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.
Measured: 6 months
Secondary outcomes (4)
Best overall Response (BOR)
Best overall response (BOR) is defined as the best response recorded from the start of the treatment until progression/recurrence using mSWAT response criteria
Measured: 2 years
Duration of response (DOR)
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
Measured: 2 years
Time to next treatment (TTNT)
Time to next treatment (TTNT) is defined as time from Cycle 1 Day 1 to initiation of alternative systemic, antineoplastic therapy
Measured: 2 years
Assess Adverse Events
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start6 Dec 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous T Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Hoosier Cancer Research Network
- Responsible party
- Sponsor
- Investigators
- Ryan Wilcox, Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05956041
- Sponsor's protocol ID
- UMCC 2022.116
- Other IDs
- HUM00231051, HCRN
- Status last verified
- May 2026
- First submitted
- 13 Jul 2023
- Last updated
- 5 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Pembrolizumab and Mogamulizumab in Advanced-stage, Relapsed/Refractory Cutaneous T-cell Lymphomas
- ClinicalTrials.gov ID
- NCT05956041
- Acronym / sponsor ID
- UMCC 2022.116
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Hoosier Cancer Research Network
- Study start
- 6 Dec 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Pembrolizumab, Drug: MogamulizumabPembrolizumab 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Age ≥ 18 years at the time of consent.
- ECOG Performance Status of ≤ 1 within 7 days prior to Cycle 1 Day 1 treatment.
- Histological confirmation of cutaneous T-cell lymphoma (Mycosis Fungoides/Sezary Syndrome) with Stage IIB-IVB disease (TNMB Classification).
- Measurable disease according to Modified Severity Weighted Assessment Tool (mSWAT) within 30 days prior to treatment.
Key exclusion criteria (17 listed)
- Patients with a known history of Human Immunodeficiency Virus (HIV) infection are excluded. NOTE: No HIV testing is required unless mandated by local health authority.
- Patients with concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV DNA) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection. NOTE: Hepatitis B and C screening tests are not required unless: (1) Known history of HBV and HCV infection or (2) As mandated by local health authority.
- Patients previously treated with checkpoint blockade, including pembrolizumab, or mogamulizumab, are excluded.
- Patients who have received disease radiation therapy within 7 days of C1D1.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to Cycle 1 Day 1. Systemic steroids at a dose less than the equivalent of 10 mg/day of prednisone and inhaled, nasal, and topical steroids are permitted as detailed in protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PembrolizumabAlso: Keytruda400mg Intravenously | Drug | Experimental |
| MogamulizumabAlso: Poteligeo1mg/kg Intravenously | Drug | Experimental |
Primary outcome
Complete Response Rate
Time frame: 6 months
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.
4 secondary outcomes
Best overall Response (BOR)
Time frame: 2 years
Duration of response (DOR)
Time frame: 2 years
Time to next treatment (TTNT)
Time frame: 2 years
Assess Adverse Events
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ryan Wilcox principal investigator
University of Michigan Rogel Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab and Mogamulizumab in people with Cutaneous T Cell Lymphoma and Fungoides Mycosis Sezary Syndrome, run by University of Michigan Rogel Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cancer AnswerLine (1-800-865-1125, CancerAnswerLine@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response Rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.