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

Immune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Status and phase: Terminated; Phase 3

Conditions: Sarcoma; Soft Tissue Sarcoma; Metastatic Sarcoma; Cancer; Synovial Sarcoma

Treatments: Biological: LV305; Biological: G305; Other: G305-matching placebo; Other: LV305-matching placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03520959

IMDZ-04-1702

V943A-003 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

A sequential regimen of LV305-matching placebo and G305-matching placebo.

Treatment:

Other: G305-matching placebo

Other: LV305-matching placebo

CMB305

Experimental group

Description:

A sequential regimen of LV305 and G305.

Treatment:

Biological: LV305

Biological: G305