Duvelisib and Nivolumab Combination for Advanced Mycosis Fungoides/Sezary Syndrome

Active, Not Recruiting Phase 1 NCT04652960

Study Description

This phase I trial assesses the safety and efficacy of duvelisib in combination with nivolumab in treating advanced stage mycosis fungoides and Sezary syndrome. Duvelisib is an inhibitor that blocks some enzymes required for cancer cell growth, while nivolumab is a monoclonal antibody that stimulates the immune system to attack cancer cells. The study aims to determine the recommended dose of the drug combination and evaluate their maximum response, complete remission rate, and duration of treatment among responding patients. Exploratory objectives include studying the serum cytokines and T-cell repertoire pre- and post-treatment. The study involves oral administration of duvelisib and intravenous injection of nivolumab every 28 days until disease progression or toxicity is observed, with follow-up for 2 years.

Study Details

Registry ID:
NCT04652960
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
Phase:
Phase 1
Target Enrollment:
38 participants
Start Date:
Age Range:
18–999 years
Healthy Volunteers:
No

Study Locations (27 sites)

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