Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05956041 · ClinicalTrials.gov registry record · Phase 2
Pembrolizumab and Mogamulizumab in Advanced-stage, Relapsed/Refractory Cutaneous T-cell Lymphomas
A Phase 2 study of Cutaneous T Cell Lymphoma and Fungoides Mycosis Sezary Syndrome, sponsored by University of Michigan Rogel Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 23
- Enrollment target
- 1
- Study location
NCT05956041: Recruiting Phase 2 study of Cutaneous T Cell Lymphoma and Fungoides Mycosis Sezary Syndrome, sponsored by University of Michigan Rogel Cancer Center.
NCT05956041 is a Phase 2 study of Cutaneous T Cell Lymphoma and Fungoides Mycosis Sezary Syndrome that is actively recruiting participants, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 23 participants, below the 67-participant average among 23 other Cutaneous T Cell Lymphoma trials with a reported enrollment target (66% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05956041, a Phase 2 study of Cutaneous T Cell Lymphoma and Fungoides Mycosis Sezary Syndrome, is actively recruiting participants, sponsored by University of Michigan Rogel Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 23 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Mogamulizumab
Study Locations (1)
Michigan
- University of Michigan Comprehensive Cancer Center - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2023-12-06 |
| Est. Completion | 2027-04 |
| Phase | Phase 2 |
What NCT05956041 shows while recruiting
NCT05956041 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 67-participant average among 23 other Cutaneous T Cell Lymphoma trials with a reported enrollment target (66% lower).
The record links to 2 conditions, with Cutaneous T Cell Lymphoma appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT05956041 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT05956041 about?
NCT05956041 is a clinical study titled "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,...
What is the current status of trial NCT05956041?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2023-12-06. Estimated completion is 2027-04.
What conditions does trial NCT05956041 study?
This clinical trial studies the following conditions: Cutaneous T Cell Lymphoma, Fungoides Mycosis Sezary Syndrome.
What interventions are being tested in trial NCT05956041?
The interventions under investigation include: Pembrolizumab (DRUG), Mogamulizumab (DRUG).
Who is sponsoring clinical trial NCT05956041?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05956041 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cutaneous T Cell Lymphoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05956041's enrollment target sits among peer trials
23 17th of 23 higher than 7 of 23 other Cutaneous T Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cutaneous T Cell Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Photopheresis in Early-stage Mycosis Fungoides
RECRUITING · Phase 2
-
Ruxolitinib Maintenance Post-Hematopoietic Stem Cell Transplant T-Cell Lymphoma
RECRUITING · Phase 2
-
A Phase 2 Trial to Assess Safety and Efficacy of Tofacitinib 2% Cream in the Treatment of Cutaneous T-cell Lymphoma (CTCL), Stages IA, IB, and IIA
RECRUITING · Phase 2
-
Depsipeptide to Treat Patients With Cutaneous T-Cell Lymphoma and Peripheral T-Cell Lymphoma
COMPLETED · Phase 2
-
Clinical Trial of HuMax-CD4, a New Drug to Treat Early Stage T-Cell Lymphoma in the Skin.
COMPLETED · Phase 2
-
A Study for Participants With Relapsed Cutaneous T-Cell Lymphoma
COMPLETED · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03616041 · 23 participants
Capsule Endoscopy for Severe Hematochezia
- NCT04348747 · 23 participants · Phase 2
Dendritic Cell Vaccines Against Her2/Her3 and Pembrolizumab for the Treatment of Brain Metastasis From Triple Negative Breast Cancer or HER2+ Breast Cancer
- NCT04587687 · 23 participants · Phase 2
Brentuximab Vedotin and Bendamustine for the Treatment of Relapsed or Refractory Follicular Lymphoma
- NCT04715022 · 23 participants · Phase 1
Sympathetic-vascular Dysfunction in Obesity and Insulin Resistance (Vitamin C Study)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI