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Synovate Study for Synovial Sarcoma, Phase 3, Randomized, Double-blind, Placebo-controlled Study For Subjects With Locally-advanced Unresectable or Metastatic Synovial Sarcoma

NCT03520959

Description:

To assess if the CMB305 vaccine regimen may help the body's immune system to slow or stop the growth of synovial sarcoma tumor and improve survival.

Related Conditions:
  • Synovial Sarcoma
Recruiting Status:

Terminated

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Synovate Study for Synovial Sarcoma, Phase 3, Randomized, Double-blind, Placebo-controlled Study For Subjects With Locally-advanced Unresectable or Metastatic Synovial Sarcoma
  • Official Title: A Phase 3, Randomized, Double Blind, Placebo Controlled Study to Determine the Efficacy and Safety of CMB305 in Unresectable Locally Advanced or Metastatic NY ESO 1+ Synovial Sarcoma Subjects Following First Line Systemic Anti Cancer Therapy (Synovate Study)

Clinical Trial IDs

  • ORG STUDY ID: IMDZ-04-1702
  • NCT ID: NCT03520959

Conditions

  • Synovial Sarcoma
  • Cancer
  • Soft Tissue Sarcoma
  • Sarcoma
  • Metastatic Sarcoma

Interventions

DrugSynonymsArms
CMB305Arm B

Purpose

To assess if the CMB305 vaccine regimen may help the body's immune system to slow or stop the growth of synovial sarcoma tumor and improve survival.

Detailed Description

      The Synovate Study is a global, randomized, double-blind, placebo-controlled, phase 3 study
      in patients with unresectable, locally-advanced or metastatic NY-ESO-1 positive synovial
      sarcoma following first-line systemic anti-cancer therapy.
    

Trial Arms

NameTypeDescriptionInterventions
Arm APlacebo ComparatorCMB305 Placebo
    Arm BExperimentalCMB305

      Eligibility Criteria

              Selected Inclusion Criteria:
      
                -  Histological diagnosis of synovial sarcoma
      
                -  Immunohistochemistry (IHC) results from tumor biopsy for NY-ESO-1 positive
      
                -  Subjects have received at least 4 but no more than 8 cycles of first-line
                   anthracycline or ifosfamide containing systemic anti-cancer therapy regimen
      
                -  Must have documentation of no evidence of disease progression of the tumor during or
                   after completion of first line systemic anti-cancer therapy
      
                -  ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1
      
                -  Age >/= 12 years
      
                -  Life expectancy of at least 6 months
      
              Selected Exclusion Criteria:
      
                -  Have received last dose of first-line systemic anti-cancer therapy or date of most
                   recent local regional therapy >28 days prior to day 1
      
                -  Have received prior NY-ESO-1 therapy
      
                -  Have received first-line systemic anti-cancer therapy with an agent other than
                   anthracycline or ifosfamide
      
                -  Have received treatment with systemic immunomodulatory agents within 28 days prior to
                   administration of the first dose of CMB305, or 5 half-lives of the drug, whichever
                   occurs sooner.
      
                -  Have significant immunosuppression from concurrent, recent, or anticipated need for
                   chronic treatment with systemic immunosuppressive dose of corticosteroids or
                   immunosuppressive medications.
      
                -  Have psychiatric or other medical illness, or any other condition that in the opinion
                   of the investigator prevents compliance with the study procedures or ability to
                   provide valid informed consent.
      
                -  Have history of uncontrolled autoimmune disease.
      
                -  Have a significant electrocardiogram finding or cardiovascular disease
      
                -  have inadequate organ function per protocol
      
                -  History of other cancer within 3 years
      
                -  Evidence of active tuberculosis or recent clinically-significant infection requiring
                   systemic therapy.
      
                -  Evidence of active HepB, HepC, or HIV infection
      
                -  Have a history of brain metastasis
      
                -  Have received cancer therapies including chemotherapy, radiation, biologic, or kinase
                   inhibitors, G-CSF, or GM-CSF within 3 weeks prior ot the first scheduled dose of
                   CMB305
      
                -  Female of child bearing potential who is pregnant, is planning to become pregnant, or
                   is breast feeding; or male who is sexually active with a female of child bearing
                   potential who is planning to become pregnant.
            
      Maximum Eligible Age:N/A
      Minimum Eligible Age:12 Years
      Eligible Gender:All
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:Progression-Free Survival
      Time Frame:From randomization to investigator-determined date of disease progression or death, assessed up to 24 months.
      Safety Issue:
      Description:PFS by investigator-determined using RECIST v1.1

      Secondary Outcome Measures

      Measure:Time to Next Treatment
      Time Frame:From last dose of CMB305 to initiation of new therapy, assessed up to 24 months.
      Safety Issue:
      Description:
      Measure:Distant Metastasis Free Survival
      Time Frame:From randomization to investigator-determined date of disease progression or death, assessed up to 24 months.
      Safety Issue:
      Description:
      Measure:Overall Response Rate
      Time Frame:From randomization to investigator-determined date of disease progression, assessed up to 24 months.
      Safety Issue:
      Description:ORR defined by RECIST v1.1
      Measure:Incidence of Treatment-Emergent Adverse Events [Safety of CMB305 vs. placebo]
      Time Frame:From randomization to investigator-determined date of disease progression or death, assessed up to 24 months.
      Safety Issue:
      Description:Safety will be assessed primarily based on reported adverse events (AEs), Medical events of interest (MEOIs), laboratory values, and concomitant medications reported from initiation of treatment with CMB305 or placebo. Medical events of interest, immune-mediated events, and AEs that occur more than 30 days after the last dose, and that are deemed as related to the study drug, will be included as TEAEs.
      Measure:Quality of Life
      Time Frame:From Day 1 to 12 months post
      Safety Issue:
      Description:Patient self reported measure of quality of life using the EQ-5D Instrument between the active treatment and placebo arms.

      Details

      Phase:Phase 3
      Primary Purpose:Interventional
      Overall Status:Recruiting
      Lead Sponsor:Immune Design

      Trial Keywords

      • Synovate Study
      • NY-ESO-1
      • cancer vaccine
      • Sarcoma
      • soft tissue sarcoma
      • immunotherapy

      Last Updated