Duvelisib and Nivolumab for the Treatment of Stage IIB-IVB Mycosis Fungoides and Sezary Syndrome

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT04652960
Phase
PHASE1
Status
Active Not Recruiting

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood samples
  • Computed Tomography — PROCEDURE
    Undergo CT scan
  • Duvelisib — DRUG
    Given PO
  • Nivolumab — BIOLOGICAL
    Given IV
  • Positron Emission Tomography — PROCEDURE
    Undergo PET
  • Punch Biopsy — PROCEDURE
    Undergo punch biopsies

Study Details

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.

Key Dates

Start date
Oct 21, 2021
Status verified
Dec 2025
Primary completion
Dec 3, 2026
Completion
Dec 3, 2026

Study Design

Enrollment
38 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (duvelisib, nivolumab)
    Patients receive duvelisib PO QD or BID on days 1-28 or days 1-14 and nivolumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo PET-CT or CT scan at baseline. Patients also undergo punch biopsy and collection of blood samples throughout the trial.

Primary Outcome Measure

Maximum tolerated dose or recommended phase II dose (RP2D) [ Time Frame: Through completion of 3 cycles (each cycle is 28 days) ]

Locations (17)

FacilityCityStateZIPSite coordinators
Mayo Clinic Hospital in ArizonaPhoenixArizona85054-
UCHealth University of Colorado HospitalAuroraColorado80045-
UM Sylvester Comprehensive Cancer Center at Coral GablesCoral GablesFlorida33146-
UM Sylvester Comprehensive Cancer Center at Deerfield BeachDeerfield BeachFlorida33442-
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980-
University of Miami Miller School of Medicine-Sylvester Cancer CenterMiamiFlorida33136-
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322-
Northwestern UniversityChicagoIllinois60611-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Mayo Clinic in RochesterRochesterMinnesota55905-
Siteman Cancer Center at Saint Peters HospitalCity of Saint PetersMissouri63376-
Siteman Cancer Center at West County HospitalCreve CoeurMissouri63141-
Siteman Cancer Center at Christian HospitalSt LouisMissouri63136-
Siteman Cancer Center-South CountySt LouisMissouri63129-
Washington University School of MedicineSt LouisMissouri63110-
NYP/Weill Cornell Medical CenterNew YorkNew York10065-
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvania15232-

Find similar trials in Phoenix, AZ

By research site
Mayo Clinic Hospital in Arizona· Phoenix, AZUCHealth University of Colorado Hospital· Aurora, COUM Sylvester Comprehensive Cancer Center at Coral Gables· Coral Gables, FLUM Sylvester Comprehensive Cancer Center at Deerfield Beach· Deerfield Beach, FLMayo Clinic in Florida· Jacksonville, FLUniversity of Miami Miller School of Medicine-Sylvester Cancer Center· Miami, FL

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