New drug combo targets Hard-to-Treat skin cancers in early trial

NCT ID NCT04652960

Ongoing Disease control Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jul 31, 2026 · Updated 2 times

Summary

This early-stage trial tests a combination of two drugs, duvelisib and nivolumab, in 38 adults with advanced mycosis fungoides or Sezary syndrome (types of skin lymphoma). The goal is to find the safest dose and see if the drugs can shrink tumors. Duvelisib blocks certain enzymes that help cancer cells grow, while nivolumab helps the immune system attack the cancer.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: duvelisib and nivolumab
What this could lead to: If this combination works, it could offer a new treatment option for people with advanced mycosis fungoides or Sezary syndrome who have not responded to prior therapy.
What could go wrong: This is a very early (Phase 1) trial with only 38 participants, so the main goal is finding a safe dose, not proving effectiveness. Side effects from the drug combination could be significant, and it may not shrink tumors in most patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

mycosis fungoides mycosis fungoides and variants Sezary syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

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

Contacts and locations

Locations

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States
Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States
Mayo Clinic Hospital in Arizona

Phoenix, Arizona, 85054, United States
Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States
Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States
NYP/Weill Cornell Medical Center

New York, New York, 10065, United States
Northwestern University

Chicago, Illinois, 60611, United States
Siteman Cancer Center at Christian Hospital

St Louis, Missouri, 63136, United States
Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, 63376, United States
Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, 63141, United States
Siteman Cancer Center-South County

St Louis, Missouri, 63129, United States
UCHealth University of Colorado Hospital

Aurora, Colorado, 80045, United States
UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, 33146, United States
UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, 33442, United States
UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136, United States
Washington University School of Medicine

St Louis, Missouri, 63110, United States

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