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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 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. The trial reports 17 study locations across 10 states.

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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.

Conditions Studied

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

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

FieldValue
Enrollment Target 38 participants
Start Date 2021-10-21
Est. Completion 2026-12-03
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

3,257 total trials

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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, categorized as Phase 1. 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 3,257 total studies on file at ClinicalTrials.gov.

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 reports 17 study locations spanning 10 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.