Study to Compare the Safety and Efficacy of CMB305 With Atezolizumab to Atezolizumab Alone in Participants With Sarcoma (IMDZ-C232/V943A-002)

Part of paid clinical trials in Palo Alto, California.

Sponsor
Immune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Study ID
NCT02609984
Phase
PHASE2
Status
Terminated

Conditions

  • Liposarcoma
  • Locally Advanced Sarcoma
  • Metastatic Sarcoma
  • Myxoid/Round Cell Liposarcoma
  • Recurrent Adult Soft Tissue Sarcoma
  • Sarcoma
  • Synovial Sarcoma

Eligibility Criteria

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

Interventions

  • CMB305 — BIOLOGICAL
    A combination of LV305 administered intradermally (ID) and G305 administered intramuscularly (IM)
  • atezolizumab — BIOLOGICAL
    IV Infusion

Study Details

This is an open-label Phase 2 randomized study that will examine the use of the study agents, CMB305 (sequentially administered LV305 which is a dendritic cell-targeting viral vector expressing the New York Esophageal Squamous Cell Carcinoma 1 gene \[NY-ESO-1\] and G305 which is a NY-ESO-1 recombinant protein plus glucopyranosyl lipid adjuvant-stable emulsion \[GLA-SE\]) in combination with atezolizumab or atezolizumab alone, in participants with locally advanced, relapsed or metastatic sarcoma (synovial or myxoid/round cell liposarcoma) expressing the NY-ESO-1 protein. There is no formal primary hypothesis for this study.

Key Dates

Start date
Apr 29, 2015
Status verified
Jun 2020
Primary completion
Feb 6, 2019
Completion
Feb 6, 2019

Study Design

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

Arms

  • Experimental: CMB305 (sequentially administered LV305 and G305)+Atezolizumab
    Participants received CMB305 treatment in combination with 1200 mg/day atezolizumab administered by intravenous (IV) infusion every 3 weeks (Q3W) for up to approximately 2 years. CMB305 treatment consisted of 2 doses of LV305 administered intradermally (ID) on Days 0 and 14 followed every 2 weeks with alternating doses of G305 administered intramuscularly (IM) and LV305. LV305 was administered at a dose of 1×10\^10 vector genomes and G305 at a dose of 5 mcg glucopyranosyl lipid A stable emulsion mixed with 250 mcg of NY ESO-1 protein.
  • Active Comparator: Atezolizumab
    Participants received 1200 mg/day atezolizumab by IV infusion Q3W for up to approximately 2 years.

Primary Outcome Measure

Progression-Free Survival (PFS) Per Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) [ Time Frame: Up to approximately 36.1 months ]

Locations (18)

FacilityCityStateZIPSite coordinators
Stanford University Medical CenterPalo AltoCalifornia94304-
Sarcoma Oncology Research CenterSanta MonicaCalifornia90403-
University of Colorado Cancer CenterAuroraColorado80045-
MedStar Washington Hospital CenterWashington D.C.District of Columbia20010-
Mayo Clinic of JacksonvilleJacksonvilleFlorida32224-
Georgia Cancer SpecialistsSandy SpringsGeorgia30342-
Northwestern University Feinburg School of MedicineChicagoIllinois60611-
University of Iowa Hospital and ClinicsIowa CityIowa52242-
Massachusetts General HospitalBostonMassachusetts02114-
Mayo Clinic RochesterRochesterMinnesota10029-
Washington University in St. LouisSt LouisMissouri63110-
Monter Cancer ResearchLake SuccessNew York11042-
Levine Cancer InstituteCharlotteNorth Carolina28204-
Duke Cancer InstituteDurhamNorth Carolina27710-
Fox Chase cancer CenterPhiladelphiaPennsylvania19111-
Vanderbilt UniversityNashvilleTennessee37232-
University of Vermont Cancer CenterBurlingtonVermont05405-
Scca/FhcrcSeattleWashington98109-

Find similar trials in Palo Alto, CA

By research site
Stanford University Medical Center· Palo Alto, CASarcoma Oncology Research Center· Santa Monica, CAUniversity of Colorado Cancer Center· Aurora, COMedStar Washington Hospital Center· Washington D.C., DCMayo Clinic of Jacksonville· Jacksonville, FLGeorgia Cancer Specialists· Sandy Springs, GA

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