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NCT04652960 · ClinicalTrials.gov registry record · Phase 1
Duvelisib and Nivolumab for the Treatment of Stage IIB-IVB Mycosis Fungoides and Sezary Syndrome
A Phase 1 study of Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v8 and Stage III Mycosis Fungoides and Sezary Syndrome AJCC v8, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
- 17
- Study locations
NCT04652960: Active Phase 1 study of Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v8 and Stage III Mycosis Fungoides and Sezary Syndrome AJCC v8, sponsored by National Cancer Institute (NCI).
NCT04652960 is a Phase 1 study of Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v8 and Stage III Mycosis Fungoides and Sezary Syndrome AJCC v8 that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 38 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower). The trial reports 17 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04652960, a Phase 1 study of Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v8 and Stage III Mycosis Fungoides and Sezary Syndrome AJCC v8, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
- 17
- Study locations
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.
Primary Outcome
If one dose-limiting toxicity (DLT) is seen in the first three patients treated at a given dose level, then three additional patients will be evaluated at that same dose level. If DLTs are present at \< 2 of 6 patients, the next dose level will be explored. If 3 patients are treated at the maximal dose level without DLT, three more patients will be enrolled to that dose level to evaluate for DLT. If \< 2/6 DLTs are seen at that dose level, it will be deemed the RP2D.
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 |
What the registry record for NCT04652960 still lists
NCT04652960 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower).
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.
NCT04652960 lists 17 locations in 10 states (Missouri, Florida, Arizona).
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.
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).
Who is sponsoring clinical trial NCT04652960?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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38 1197th of 2000 higher than 797 of 2,000 other Phase 1 trials
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