Trials / Terminated
TerminatedNCT03520959
A Phase 3, Randomized, Double-blind, Placebo-controlled Study For Subjects With Locally-advanced Unresectable or Metastatic Synovial Sarcoma (V943-003, IMDZ-04-1702)
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)
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1 (actual)
- Sponsor
- Immune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2018-09-18
- Primary completion
- 2018-11-20
- Completion
- 2018-11-20
- First posted
- 2018-05-11
- Last updated
- 2020-04-16
- Results posted
- 2020-04-16
Locations
29 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03520959. Inclusion in this directory is not an endorsement.