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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 : Active, not recruiting
First Posted : May 10, 2018
Last Update Posted : October 29, 2018
Sponsor:
Information provided by (Responsible Party):
Immune Design

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.

Condition or disease Intervention/treatment Phase
Synovial Sarcoma Cancer Soft Tissue Sarcoma Sarcoma Metastatic Sarcoma Biological: CMB305 Other: Placebo Phase 3

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 : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : September 18, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Arm A
CMB305 Placebo
Other: Placebo
CMB305 placebo control

Experimental: Arm B
CMB305
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}]




Primary Outcome Measures :
  1. 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

  2. Overall Survival [ Time Frame: From randomization to date of death, assessed up to 66 months. ]

Secondary Outcome Measures :
  1. Time to Next Treatment [ Time Frame: From last dose of CMB305 to initiation of new therapy, assessed up to 24 months. ]
  2. Distant Metastasis Free Survival [ Time Frame: From randomization to investigator-determined date of disease progression or death, assessed up to 24 months. ]
  3. 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

  4. 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.

  5. 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.



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03520959


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Sponsors and Collaborators
Immune Design

Responsible Party: Immune Design
ClinicalTrials.gov Identifier: NCT03520959     History of Changes
Other Study ID Numbers: IMDZ-04-1702
First Posted: May 10, 2018    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Immune Design:
Synovate Study
NY-ESO-1
cancer vaccine
Sarcoma
soft tissue sarcoma
immunotherapy

Additional relevant MeSH terms:
Sarcoma
Sarcoma, Synovial
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue