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Duvelisib and Nivolumab for the Treatment of Stage IIB-IVB Mycosis Fungoides and Sezary Syndrome
NCT04652960 · View on ClinicalTrials.gov ↗
Study Summary
This phase I trial identifies the best dose, possible benefits, and/or side effects of duvelisib in combination with nivolumab in treating patients with stage IIB-IVB mycosis fungoides and Sezary syndrome. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving duvelisib in combination with nivolumab may work better than giving each of these drugs individually, or treating with the usual approach in patients with mycosis fungoides and Sezary syndrome.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Positron Emission Tomography
- BIOLOGICAL Nivolumab
- DRUG Duvelisib
Study Locations (17)
Missouri
- Siteman Cancer Center at Saint Peters Hospital — City of Saint Peters
- Siteman Cancer Center at West County Hospital — Creve Coeur
- Washington University School of Medicine — St Louis
- Siteman Cancer Center-South County — St Louis
- Siteman Cancer Center at Christian Hospital — St Louis
Florida
- UM Sylvester Comprehensive Cancer Center at Coral Gables — Coral Gables
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach — Deerfield Beach
- Mayo Clinic in Florida — Jacksonville
- University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami
Arizona
- Mayo Clinic Hospital in Arizona — Phoenix
Colorado
- UCHealth University of Colorado Hospital — Aurora
Georgia
- Emory University Hospital/Winship Cancer Institute — Atlanta
Illinois
- Northwestern University — Chicago
Massachusetts
- Dana-Farber Cancer Institute — Boston
Minnesota
- Mayo Clinic in Rochester — Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2021-10-21 |
| Est. Completion | 2026-12-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04652960
The ClinicalTrials.gov registry entry for NCT04652960 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v8 appearing as the primary indexed condition, and to 5 interventions — of which Biospecimen Collection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04652960 reports 17 study locations spanning 10 distinct geographic areas — top geographies include Missouri, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04652960 about?
NCT04652960 is a clinical study titled "Duvelisib and Nivolumab for the Treatment of Stage IIB-IVB Mycosis Fungoides and Sezary Syndrome". This phase I trial identifies the best dose, possible benefits, and/or side effects of duvelisib in combination with nivolumab in treating patients with stage IIB-IVB mycosis fungoides and Sezary syndrome. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell g...
What is the current status of trial NCT04652960?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2021-10-21. Estimated completion is 2026-12-03.
What conditions does trial NCT04652960 study?
This clinical trial studies the following conditions: Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v8, Stage III Mycosis Fungoides and Sezary Syndrome AJCC v8, Stage IV Mycosis Fungoides and Sezary Syndrome AJCC v8. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04652960?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Positron Emission Tomography (PROCEDURE), Nivolumab (BIOLOGICAL), Duvelisib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04652960?
This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04652960 being conducted?
This trial has 17 study locations across Arizona, Colorado, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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