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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

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ClinicalTrials.gov Identifier: NCT03520959
Recruitment Status : Terminated (Study was terminated due to sponsor's decision.)
First Posted : May 10, 2018
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
Immune Design

Tracking Information
First Submitted Date  ICMJE March 30, 2018
First Posted Date  ICMJE May 10, 2018
Last Update Posted Date March 7, 2019
Actual Study Start Date  ICMJE September 18, 2018
Actual Primary Completion Date November 19, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2018)
  • Progression-Free Survival [ Time Frame: From randomization to investigator-determined date of disease progression or death, assessed up to 24 months. ]
    PFS by investigator-determined using RECIST v1.1
  • Overall Survival [ Time Frame: From randomization to date of death, assessed up to 66 months. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03520959 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2018)
  • Time to Next Treatment [ Time Frame: From last dose of CMB305 to initiation of new therapy, assessed up to 24 months. ]
  • Distant Metastasis Free Survival [ Time Frame: From randomization to investigator-determined date of disease progression or death, assessed up to 24 months. ]
  • Overall Response Rate [ Time Frame: From randomization to investigator-determined date of disease progression, assessed up to 24 months. ]
    ORR defined by RECIST v1.1
  • 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 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.
  • Quality of Life [ Time Frame: From Day 1 to 12 months post ]
    Patient self reported measure of quality of life using the EQ-5D Instrument between the active treatment and placebo arms.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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)
Brief Summary 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Synovial Sarcoma
  • Cancer
  • Soft Tissue Sarcoma
  • Sarcoma
  • Metastatic Sarcoma
Intervention  ICMJE
  • Biological: CMB305
    Sequentially administered LV305 [lentiviral vector encoding New York esophogeal squamous cell carcinoma-1 {NY-ESO-1} gene] and G305 [NY-ESO-1 recombinant protein plus glucopyranosyl lipid A stable emulsion {GLA-SE}]
  • Other: Placebo
    CMB305 placebo control
Study Arms  ICMJE
  • Placebo Comparator: Arm A
    CMB305 Placebo
    Intervention: Other: Placebo
  • Experimental: Arm B
    CMB305
    Intervention: Biological: CMB305
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 25, 2018)
1
Original Estimated Enrollment  ICMJE
 (submitted: April 27, 2018)
248
Actual Study Completion Date  ICMJE November 20, 2018
Actual Primary Completion Date November 19, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03520959
Other Study ID Numbers  ICMJE IMDZ-04-1702
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Immune Design
Study Sponsor  ICMJE Immune Design
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Immune Design
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP