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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)

Terminated Phase 3 Results posted Last updated 16 April 2020
What this trial tests

Phase 3 trial testing LV305 in Synovial Sarcoma in 1 participant. Terminated before completion.

Timeline
18 September 2018
Primary endpoint
20 November 2018
20 November 2018

Quick facts

Lead sponsorImmune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
PhasePhase 3
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment1
Start date18 September 2018
Primary completion20 November 2018
Estimated completion20 November 2018
Sites29 locations across Canada, United States

Drugs / interventions tested

Conditions studied

Sponsor

Immune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) — full company profile →

Who can join

12 and older, any sex, with Synovial Sarcoma or Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Who Experienced a Treatment-Emergent Adverse Event (TEAE) Secondary · From randomization to investigator-determined date of disease progression or death, assessed up to approximately 2 months.

Safety will be assessed primarily based on reported adverse events (AEs), Medical Events of Interest (MEOIs), laboratory values, and concomitant medications reported from initiation of treatment with CMB305 or placebo.

GroupValue95% CI
CMB3051
Number of Participants Who Discontinued Study Treatment Due to an AE Secondary · Up to approximately 2 months

The number of all participants who discontinued study treatment due to an AE is presented.

GroupValue95% CI
CMB3050

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Opposing immune and genetic mechanisms shape oncogenic programs in synovial sarcoma.
    Jerby-Arnon L, Neftel C, Shore ME, Weisman HR, et al · · 2021 · cited 108× · PMID 33495604 · DOI 10.1038/s41591-020-01212-6
  2. Cancer Vaccines: Antigen Selection Strategy.
    Zhao Y, Baldin AV, Isayev O, Werner J, et al · · 2021 · cited 47× · PMID 33503926 · DOI 10.3390/vaccines9020085
  3. Pathogen Molecular Pattern Receptor Agonists: Treating Cancer by Mimicking Infection.
    Aleynick M, Svensson-Arvelund J, Flowers CR, Marabelle A, et al · · 2019 · cited 45× · PMID 31123052 · DOI 10.1158/1078-0432.ccr-18-1800
  4. Current advances in cancer vaccines targeting NY-ESO-1 for solid cancer treatment.
    Zhou H, Ma Y, Liu F, Li B, et al · · 2023 · cited 26× · PMID 37731507 · DOI 10.3389/fimmu.2023.1255799
  5. Dendritic Cell-Based and Other Vaccination Strategies for Pediatric Cancer.
    de Bruijn S, Anguille S, Verlooy J, Smits EL, et al · · 2019 · cited 14× · PMID 31546858 · DOI 10.3390/cancers11091396
  6. Genetic and Molecular Heterogeneity of Synovial Sarcoma and Associated Challenges in Therapy.
    Lesovaya EA, Fetisov TI, Bokhyan BY, Maksimova VP, et al · · 2024 · cited 7× · PMID 39451213 · DOI 10.3390/cells13201695
  7. Advances and challenges in cancer immunotherapy: mechanisms, clinical applications, and future directions.
    Vatsavai N, Kaur Bhinder S, Shaik R, Mahira S, et al · · 2025 · cited 5× · PMID 40584631 · DOI 10.3389/fphar.2025.1602529
  8. Breaking barriers: Smart vaccine platforms for cancer immunomodulation.
    Gomari MM, Ghantabpour T, Pourgholam N, Rostami N, et al · · 2025 · cited 5× · PMID 39901621 · DOI 10.1002/cac2.70002

Verify or expand the search:

Other recruiting trials for Synovial Sarcoma

Currently open trials in the same condition.

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

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03520959.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing