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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05956041
The ClinicalTrials.gov registry entry for NCT05956041 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 67-participant average among 23 other Cutaneous T Cell Lymphoma trials with a reported enrollment target (66% lower). The listed sponsor is University of Michigan Rogel Cancer Center, which has 292 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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