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

April 3, 2020 updated by: Immune Design

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)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Edmonton, Canada
        • University of Alberta Hospital- Cross Cancer Institute
      • Montréal-Est, Canada
        • McGill University
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic- Scottsdale
      • Tucson, Arizona, United States, 85724
        • University of Arizona Cancer Center
    • California
      • Los Angeles, California, United States, 90033
        • Usc Norris Comprehensive Cancer Center
      • Palo Alto, California, United States, 94305
        • Stanford University
      • Santa Monica, California, United States, 90403
        • Sarcoma Oncology Center
    • Colorado
      • Boulder, Colorado, United States, 80309
        • University of Colorado Cancer Center
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University School of Medicine- Cancer Center
    • Florida
      • Coral Gables, Florida, United States, 33146
        • University of Miami
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic- Jacksonville
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center at USF
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute/Mass General Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University in St. Louis
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Nebraska Methodist Hospital
    • New Jersey
      • Edison, New Jersey, United States, 08837
        • Hackensack University Medical Center
    • New York
      • Astoria, New York, United States, 11105
        • Cohen Children's Medical Center (Northwell)
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
    • North Carolina
      • Durham, North Carolina, United States, 27708
        • Duke University
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital
      • Columbus, Ohio, United States, 43210
        • Ohio State University
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
      • Pittsburgh, Pennsylvania, United States, 15224
        • University of Pittsburgh Medical Center
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
From randomization to investigator-determined date of disease progression or death, assessed up to 24 months.
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.
From randomization to date of death, assessed up to 66 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From last dose of CMB305 to initiation of new therapy, assessed up to 24 months.
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.
From randomization to investigator-determined date of disease progression or death, assessed up to 24 months.
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.
From randomization to investigator-determined date of disease progression, assessed up to 24 months.
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.
From randomization to investigator-determined date of disease progression or death, assessed up to approximately 2 months.
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).
From Day 1 up to 12 months
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.
Up to approximately 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Immune Design

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2018

Primary Completion (Actual)

November 20, 2018

Study Completion (Actual)

November 20, 2018

Study Registration Dates

First Submitted

March 30, 2018

First Submitted That Met QC Criteria

April 27, 2018

First Posted (Actual)

May 11, 2018

Study Record Updates

Last Update Posted (Actual)

April 16, 2020

Last Update Submitted That Met QC Criteria

April 3, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMDZ-04-1702
  • V943A-003 (Other Identifier: Merck Unique ID)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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