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

NCT05956041 | Recruiting Phase 2 FDA Drug

• 3 other identifiers: UMCC 2022.116HUM00231051HCRN
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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. 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

Cutaneous T Cell Lymphoma; Fungoides Mycosis Sezary Syndrome

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (4)

• Best overall Response (BOR)

  2 years

• Duration of response (DOR)

  2 years

• Time to next treatment (TTNT)

  2 years

• Assess Adverse Events

  2 years

Study Arms (1)

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

Drug: Pembrolizumab; Drug: Mogamulizumab

Interventions

Pembrolizumab DRUG

400mg Intravenously

Also known as: Keytruda

Experimental

Mogamulizumab DRUG

1mg/kg Intravenously

Also known as: Poteligeo

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: collaborator
• Hoosier Cancer Research Network: collaborator
• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell, Cutaneous

Interventions

pembrolizumab; mogamulizumab

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Ryan Wilcox

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cancer AnswerLine

CONTACT

1-800-865-1125; CancerAnswerLine@med.umich.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: July 21, 2023
• Study Start: December 6, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)