Study Stopped
Study was terminated due to sponsor's decision.
A Phase 3, Randomized, Double-blind, Placebo-controlled Study For Subjects With Locally-advanced Unresectable or Metastatic Synovial Sarcoma (V943-003, IMDZ-04-1702)
2 other identifiers
interventional
1
2 countries
29
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Sep 2018
Shorter than P25 for phase_3
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 30, 2018
CompletedFirst Posted
Study publicly available on registry
May 11, 2018
CompletedStudy Start
First participant enrolled
September 18, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 20, 2018
CompletedResults Posted
Study results publicly available
April 16, 2020
CompletedApril 16, 2020
April 1, 2020
2 months
March 30, 2018
February 26, 2020
April 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Progression-Free Survival (PFS)
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)
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 Outcomes (6)
Time to Next Treatment (TTNT)
From last dose of CMB305 to initiation of new therapy, assessed up to 24 months.
Distant Metastasis Free Survival (DMFS)
From randomization to investigator-determined date of disease progression or death, assessed up to 24 months.
Overall Response Rate (ORR)
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)
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
From Day 1 up to 12 months
- +1 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORA sequential regimen of LV305-matching placebo and G305-matching placebo.
CMB305
EXPERIMENTALA sequential regimen of LV305 and G305.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
Mayo Clinic- Scottsdale
Scottsdale, Arizona, 85259, United States
University of Arizona Cancer Center
Tucson, Arizona, 85724, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Stanford University
Palo Alto, California, 94305, United States
Sarcoma Oncology Center
Santa Monica, California, 90403, United States
University of Colorado Cancer Center
Boulder, Colorado, 80309, United States
Yale University School of Medicine- Cancer Center
New Haven, Connecticut, 06520, United States
University of Miami
Coral Gables, Florida, 33146, United States
Mayo Clinic- Jacksonville
Jacksonville, Florida, 32224, United States
Moffitt Cancer Center at USF
Tampa, Florida, 33612, United States
Northwestern
Chicago, Illinois, 60611, United States
Dana Farber Cancer Institute/Mass General Hospital
Boston, Massachusetts, 02215, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Washington University in St. Louis
St Louis, Missouri, 63110, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
Hackensack University Medical Center
Edison, New Jersey, 08837, United States
Cohen Children's Medical Center (Northwell)
Astoria, New York, 11105, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Duke University
Durham, North Carolina, 27708, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229, United States
Ohio State University
Columbus, Ohio, 43210, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15224, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
University of Alberta Hospital- Cross Cancer Institute
Edmonton, Canada
McGill University
Montreal East, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Study was stopped early due to Sponsor decision.
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2018
First Posted
May 11, 2018
Study Start
September 18, 2018
Primary Completion
November 20, 2018
Study Completion
November 20, 2018
Last Updated
April 16, 2020
Results First Posted
April 16, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share