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A Phase 3, Randomized, Double-blind, Placebo-controlled Study For Subjects With Locally-advanced Unresectable or Metastatic Synovial Sarcoma (V943-003, IMDZ-04-1702)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03520959
Recruitment Status : Terminated (Study was terminated due to sponsor's decision.)
First Posted : May 11, 2018
Results First Posted : April 1, 2020
Last Update Posted : April 16, 2020
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: LV305 Biological: G305 Other: LV305-matching placebo Other: G305-matching 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 New York esophageal squamous cell carcinoma 1 (NY-ESO-1) positive synovial sarcoma following first-line systemic anti-cancer therapy.

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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 Participants Following First Line Systemic Anti-cancer Therapy (V943-003, IMDZ-04-1702)
Actual Study Start Date : September 18, 2018
Actual Primary Completion Date : November 20, 2018
Actual Study Completion Date : November 20, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
A sequential regimen of LV305-matching placebo and G305-matching placebo.
Other: LV305-matching placebo
Administered via SC injection.

Other: G305-matching placebo
Administered via IM injection.

Experimental: CMB305
A sequential regimen of LV305 and G305.
Biological: LV305
Administered via subcutaneous (SC) injection.

Biological: G305
Administered via intramuscular (IM) injection.




Primary Outcome Measures :
  1. Progression-Free Survival (PFS) [ Time Frame: From randomization to investigator-determined date of disease progression or death, assessed up to 24 months. ]
    PFS is defined as the time from randomization to the investigator-determined date of disease progression or death, whichever comes first, using Response Evaluation Criteria in Solid Tumors (RECIST v1.1).

  2. Overall Survival (OS) [ Time Frame: From randomization to date of death, assessed up to 66 months. ]
    OS is defined as the time from randomization to the date of death.


Secondary Outcome Measures :
  1. Time to Next Treatment (TTNT) [ Time Frame: From last dose of CMB305 to initiation of new therapy, assessed up to 24 months. ]
    TTNT is defined as the time from randomization to the start of post-study treatment subsequent intervention: [TTNT = start date of subsequent intervention - randomization date + 1]. Subsequent intervention includes anticancer therapy, cancer-related surgery and local regional therapy. Participants who do not start any post-study treatment intervention will be censored at their last known date of being alive.

  2. Distant Metastasis Free Survival (DMFS) [ Time Frame: From randomization to investigator-determined date of disease progression or death, assessed up to 24 months. ]
    DMFS is defined as the time from randomization to evidence of a new distant metastasis not documented at time of randomization: [DMFS = a new distant metastasis documented date - randomization date + 1]. Participants who do not have any new distant metastasis will be censored at their last tumor assessment.

  3. Overall Response Rate (ORR) [ Time Frame: From randomization to investigator-determined date of disease progression, assessed up to 24 months. ]
    ORR defined by RECIST v1.1 will be summarized by the number and percent of subjects who achieve a complete response (CR) or partial response (PR) based on the investigator's assessment. ORR will be compared between treatment arms using a logistic regression.

  4. Number of Participants Who Experienced a Treatment-Emergent Adverse Event (TEAE) [ Time Frame: From randomization to investigator-determined date of disease progression or death, assessed up to approximately 2 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.

  5. Quality of Life (QoL): EuroQol 5-Dimension 5 Level (EQ-5D-5L) and EuroQol 5-Dimension Youth (EQ-5D-Y) Questionnaires [ Time Frame: From Day 1 up to 12 months ]
    QoL evaluated using the EQ-5D-5L for participants ≥18 years of age or using the EQ-5D-Y for participants 12 to <18 years of age. EQ-5D-5L descriptive system is comprised of 5 dimensions-mobility, self-care, usual activities, pain/discomfort & anxiety/depression. Each dimension has 5 levels: not at all (level 1), mild (level 2), moderate (level 3), severe (level 4), extreme/leading to incapacity (level 5), with highest level corresponding to worst outcome. Participants indicated their health state by choosing the appropriate level from each dimension. The 5 digit health states thus obtained for each dimension were then converted into a single median index value using the EQ-5D-5L crosswalk index value calculator as recommended by EuroQol group. In the EQ-VAS, participants recorded their health state on a scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).

  6. Number of Participants Who Discontinued Study Treatment Due to an AE [ Time Frame: Up to approximately 2 months ]
    The number of all participants who discontinued study treatment due to an AE is presented.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 New York esophageal squamous cell carcinoma 1 (NY-ESO-1) are positive
  • Participants 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 anti-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 Hepatitis B, Hepatitis C, or Human Immunodeficiency virus (HIV) infection
  • Have a history of brain metastasis
  • Have received cancer therapies including chemotherapy, radiation, biologic, or kinase inhibitors, granulocyte-colony stimulating factor (G-CSF), or granulocyte-macrophage colony-stimulating factor (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


Locations
Show Show 29 study locations
Sponsors and Collaborators
Immune Design
  Study Documents (Full-Text)

Documents provided by Immune Design:
Study Protocol  [PDF] September 19, 2018
Statistical Analysis Plan  [PDF] May 25, 2018

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Responsible Party: Immune Design
ClinicalTrials.gov Identifier: NCT03520959    
Other Study ID Numbers: IMDZ-04-1702
V943A-003 ( Other Identifier: Merck Unique ID )
First Posted: May 11, 2018    Key Record Dates
Results First Posted: April 1, 2020
Last Update Posted: April 16, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Sarcoma
Sarcoma, Synovial
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue