A Phase 3, Randomized, Double-blind, Placebo-controlled Study For Subjects With Locally-advanced Unresectable or Metastatic Synovial Sarcoma (V943-003, IMDZ-04-1702)
NCT ID: NCT03520959
Last Updated: 2020-04-16
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE3
1 participants
INTERVENTIONAL
2018-09-18
2018-11-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study to Compare the Safety and Efficacy of CMB305 With Atezolizumab to Atezolizumab Alone in Participants With Sarcoma (IMDZ-C232/V943A-002)
NCT02609984
Phase 1 Study of Intradermal LV305 in Patients With Locally Advanced, Relapsed or Metastatic Cancer Expressing NY-ESO-1
NCT02122861
NY-ESO-1 Specific T Cells After Cyclophosphamide in Treating Patients With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma
NCT02059850
Vaccine Therapy in Treating Patients With Primary Stage II Melanoma
NCT00005052
Allogeneic, Antigen-Presenting, GM-CSF-secreting, SV-BR-1-GM Whole Cell-Therapeutic Vaccine and Immunotherapy: A Phase I Pilot Safety and Feasibility Study for Solid Tumor Patients With CNS Metastases
NCT07199413
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
A sequential regimen of LV305-matching placebo and G305-matching placebo.
LV305-matching placebo
Administered via SC injection.
G305-matching placebo
Administered via IM injection.
CMB305
A sequential regimen of LV305 and G305.
LV305
Administered via subcutaneous (SC) injection.
G305
Administered via intramuscular (IM) injection.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
LV305
Administered via subcutaneous (SC) injection.
G305
Administered via intramuscular (IM) injection.
LV305-matching placebo
Administered via SC injection.
G305-matching placebo
Administered via IM injection.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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.
12 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Immune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mayo Clinic- Scottsdale
Scottsdale, Arizona, United States
University of Arizona Cancer Center
Tucson, Arizona, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Stanford University
Palo Alto, California, United States
Sarcoma Oncology Center
Santa Monica, California, United States
University of Colorado Cancer Center
Boulder, Colorado, United States
Yale University School of Medicine- Cancer Center
New Haven, Connecticut, United States
University of Miami
Coral Gables, Florida, United States
Mayo Clinic- Jacksonville
Jacksonville, Florida, United States
Moffitt Cancer Center at USF
Tampa, Florida, United States
Northwestern
Chicago, Illinois, United States
Dana Farber Cancer Institute/Mass General Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Washington University in St. Louis
St Louis, Missouri, United States
Nebraska Methodist Hospital
Omaha, Nebraska, United States
Hackensack University Medical Center
Edison, New Jersey, United States
Cohen Children's Medical Center (Northwell)
Astoria, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Duke University
Durham, North Carolina, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance
Seattle, Washington, United States
University of Alberta Hospital- Cross Cancer Institute
Edmonton, , Canada
McGill University
Montreal East, , Canada
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
V943A-003
Identifier Type: OTHER
Identifier Source: secondary_id
IMDZ-04-1702
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.