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

NCT03520959 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2020-04-16

Study results available
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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.

Conditions

  • Synovial Sarcoma
  • Cancer
  • Soft Tissue Sarcoma
  • Sarcoma
  • Metastatic Sarcoma

Interventions

BIOLOGICAL

LV305

Administered via subcutaneous (SC) injection.

BIOLOGICAL

G305

Administered via intramuscular (IM) injection.

OTHER

LV305-matching placebo

Administered via SC injection.

OTHER

G305-matching placebo

Administered via IM injection.

Sponsors & Collaborators

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

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-18
Primary Completion
2018-11-20
Completion
2018-11-20
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03520959 on ClinicalTrials.gov