OncoMatch/Clinical Trials/NCT05956041
Pembrolizumab and Mogamulizumab in Advanced-stage, Relapsed/Refractory Cutaneous T-cell Lymphomas
Is NCT05956041 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Pembrolizumab and Mogamulizumab for cutaneous t cell lymphoma.
Treatment: Pembrolizumab · Mogamulizumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Disease stage
Required: Stage IIB, III, IIIA, IIIB, IV, IVA, IVB (TNMB Classification)
Stage IIB-IVB disease (TNMB Classification)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic therapy (extracorporeal photopheresis)
Patients must have failed at least one prior line of systemic therapy. This includes ECP.
Cannot have received: checkpoint inhibitor (pembrolizumab)
Patients previously treated with checkpoint blockade, including pembrolizumab, or mogamulizumab, are excluded.
Cannot have received: monoclonal antibody (mogamulizumab)
Patients previously treated with checkpoint blockade, including pembrolizumab, or mogamulizumab, are excluded.
Cannot have received: allogeneic stem cell transplant
Prior allogeneic stem cell transplant or allogeneic cellular therapies, recent immunosuppressive therapies (for any reason).
Cannot have received: solid organ transplant
Prior solid organ transplant.
Lab requirements
Blood counts
Absolute Neutrophil Count (ANC) ≥ 500/µL; Hemoglobin (Hgb) ≥ 8 g/dL; Platelet Count ≥ 25,000/µL
Kidney function
Creatinine OR Measured or calculated creatinine clearance ≤ 1.5 × ULN OR ≥ 30 mL/min for participant with creatinine levels > 1.5 × institutional ULN
Liver function
Bilirubin ≤ 1.5 ×ULN OR direct bilirubin ≤ ULN for participants with total bilirubin levels > 1.5 × ULN; AST ≤ 2.5 × ULN (≤ 5 × ULN for participants with liver metastases); ALT ≤ 2.5 × ULN (≤ 5 × ULN for participants with liver metastases)
Demonstrate adequate organ function as defined below. All screening labs to be obtained within 28 days prior to Cycle 1 Day 1.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Michigan Comprehensive Cancer Center · Ann Arbor, Michigan
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