Clinical trial NCT03520959: A Phase 3, Randomized, Double-blind, Placebo-controlled Study For Subjects With Locally-advanced Unresectable or Metastatic Synovial Sarcoma (V943-003, IMDZ-04-1702)
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Synovial Sarcoma
Cancer
Soft Tissue Sarcoma
Sarcoma
Metastatic Sarcoma
Keywords: Synovate Study
NY-ESO-1
cancer vaccine
Sarcoma
soft tissue sarcoma
immunotherapy
Lead sponsor: Immune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Sponsor class: INDUSTRY
First posted: 2018-05-11
Enrollment: 1
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: From randomization to investigator-determined date of disease progression or death, assessed up to 24 months.
measure: Overall Survival (OS)
timeFrame: From randomization to date of death, assessed up to 66 months.
Secondary outcomes:
measure: Time to Next Treatment (TTNT)
timeFrame: From last dose of CMB305 to initiation of new therapy, assessed up to 24 months.
measure: Distant Metastasis Free Survival (DMFS)
timeFrame: From randomization to investigator-determined date of disease progression or death, assessed up to 24 months.
measure: Overall Response Rate (ORR)
timeFrame: From randomization to investigator-determined date of disease progression, assessed up to 24 months.
measure: Number of Participants Who Experienced a Treatment-Emergent Adverse Event (TEAE)
timeFrame: From randomization to investigator-determined date of disease progression or death, assessed up to approximately 2 months.
measure: Quality of Life (QoL): EuroQol 5-Dimension 5 Level (EQ-5D-5L) and EuroQol 5-Dimension Youth (EQ-5D-Y) Questionnaires
timeFrame: From Day 1 up to 12 months
measure: Number of Participants Who Discontinued Study Treatment Due to an AE
timeFrame: Up to approximately 2 months
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic- Scottsdale
state: Arizona
city: Tucson
country: United States
facility: University of Arizona Cancer Center
state: Arizona
city: Los Angeles
country: United States
facility: USC Norris Comprehensive Cancer Center
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Santa Monica
country: United States
facility: Sarcoma Oncology Center
state: California
city: Boulder
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: New Haven
country: United States
facility: Yale University School of Medicine- Cancer Center
state: Connecticut
city: Coral Gables
country: United States
facility: University of Miami
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic- Jacksonville
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center at USF
state: Florida
city: Chicago
country: United States
facility: Northwestern
state: Illinois
city: Boston
country: United States
facility: Dana Farber Cancer Institute/Mass General Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Omaha
country: United States
facility: Nebraska Methodist Hospital
state: Nebraska
city: Edison
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Astoria
country: United States
facility: Cohen Children's Medical Center (Northwell)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance
state: Washington
city: Edmonton
country: Canada
facility: University of Alberta Hospital- Cross Cancer Institute
city: Montréal-Est
country: Canada
facility: McGill University
Study officials:
References: