ENVASARC: Envafolimab And Envafolimab With Ipilimumab In Patients With Undifferentiated Pleomorphic Sarcoma Or Myxofibrosarcoma

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Tracon Pharmaceuticals Inc.
Study ID
NCT04480502
Phase
PHASE2
Status
Unknown

Conditions

  • Myxofibrosarcoma
  • Undifferentiated Pleomorphic Sarcoma

Eligibility Criteria

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

Interventions

  • Envafolimab — BIOLOGICAL
    PD-L1 single domain antibody for subcutaneous injection.
  • Ipilimumab — DRUG
    CTLA-4 monoclonal antibody

Study Details

This is a multicenter open-label, randomized, non-comparative, parallel cohort pivotal study of treatment with envafolimab (cohort A and C) or envafolimab combined with ipilimumab (cohort B and D) in patients with locally advanced, unresectable or metastatic undifferentiated pleomorphic sarcoma (UPS)/myxofibrosarcoma (MFS) who have progressed on one or two lines of chemotherapy.

Key Dates

Start date
Dec 9, 2020
Status verified
May 2024
Primary completion
Oct 31, 2024
Completion
Oct 31, 2024

Study Design

Enrollment
207 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A
    Patients treated with 300 mg of single agent envafolimab every three weeks
  • Experimental: Cohort B
    Patients treated with envafolimab in combination with ipilimumab. Envafolimab will be given at 300 mg every three weeks. Ipilimumab will be given at 1 mg/kg every three weeks for a total of four doses.
  • Experimental: Cohort C
    Patients treated with 600 mg of single agent envafolimab every three weeks
  • Experimental: Cohort D
    Patients treated with envafolimab in combination with ipilimumab. Envafolimab will be given at 600 mg every three weeks. Ipilimumab will be given at 1 mg/kg every three weeks for a total of four doses.

Primary Outcome Measure

Objective response rate (ORR) by RECIST 1.1 assessed by blinded independent central review [ Time Frame: 40 months ]

Locations (29)

FacilityCityStateZIPSite coordinators
University of ArizonaTucsonArizona85721-
University of California, Los AngelesLos AngelesCalifornia90095-
Sarcoma Oncology Research CenterSanta MonicaCalifornia90403-
Stanford UniversityStanfordCalifornia94305-
University of ColoradoAuroraColorado80045-
Mayo Clinic, JacksonvilleJacksonvilleFlorida32224-
University of MiamiMiamiFlorida33136-
H. Lee Moffitt Cancer CenterTampaFlorida33612-
Northwestern UniversityEvanstonIllinois60208-
Johns Hopkins UniversityBaltimoreMaryland21218-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
University of MichiganAnn ArborMichigan48109-
Mayo Clinic RochesterRochesterMinnesota55901-
Washington University in St. LouisSt LouisMissouri63130-
Columbia UniversityNew YorkNew York10027-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Duke UniversityDurhamNorth Carolina27708-
Cleveland ClinicClevelandOhio89106-
University HospitalsClevelandOhio44106-
Ohio State UniversityColumbusOhio43210-
Thomas Jefferson University (Sidney Kimmel Cancer Center)PhiladelphiaPennsylvania19107-
University of PennsylvaniaPhiladelphiaPennsylvania19106-
University of PittsburghPittsburghPennsylvania15260-
Vanderbilt UniversityNashvilleTennessee37235-
Huntsman Cancer InstituteSalt Lake CityUtah84112-
Virginia Commonwealth UniversityRichmondVirginia23284-
Seattle Cancer Care AllianceSeattleWashington98109-
Medical College of WisconsinWauwatosaWisconsin53226-

Find similar trials in Tucson, AZ

By research site
University of Arizona· Tucson, AZUniversity of California, Los Angeles· Los Angeles, CASarcoma Oncology Research Center· Santa Monica, CAStanford University· Stanford, CAUniversity of Colorado· Aurora, COMayo Clinic, Jacksonville· Jacksonville, FL

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