Trials / Terminated
TerminatedNCT02609984
Study to Compare the Safety and Efficacy of CMB305 With Atezolizumab to Atezolizumab Alone in Participants With Sarcoma (IMDZ-C232/V943A-002)
A Randomized, Open-Label, Phase 2 Trial of CMB305 (Sequentially Administered LV305 and G305) and Atezolizumab in Patients With Locally Advanced, Relapsed, or Metastatic Sarcoma Expressing NY-ESO-1
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 89 (actual)
- Sponsor
- Immune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is an open-label Phase 2 randomized study that will examine the use of the study agents, CMB305 (sequentially administered LV305 which is a dendritic cell-targeting viral vector expressing the New York Esophageal Squamous Cell Carcinoma 1 gene \[NY-ESO-1\] and G305 which is a NY-ESO-1 recombinant protein plus glucopyranosyl lipid adjuvant-stable emulsion \[GLA-SE\]) in combination with atezolizumab or atezolizumab alone, in participants with locally advanced, relapsed or metastatic sarcoma (synovial or myxoid/round cell liposarcoma) expressing the NY-ESO-1 protein. There is no formal primary hypothesis for this study.
Detailed description
This study is designed to investigate and examine the time to progression and overall survival for CMB305 in combination with atezolizumab or atezolizumab alone in the treatment of participants with sarcoma expressing NY-ESO-1 protein.
Conditions
- Sarcoma
- Myxoid/Round Cell Liposarcoma
- Synovial Sarcoma
- Metastatic Sarcoma
- Recurrent Adult Soft Tissue Sarcoma
- Locally Advanced Sarcoma
- Liposarcoma
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CMB305 | A combination of LV305 administered intradermally (ID) and G305 administered intramuscularly (IM) |
| BIOLOGICAL | atezolizumab | IV Infusion |
Timeline
- Start date
- 2015-04-29
- Primary completion
- 2019-02-06
- Completion
- 2019-02-06
- First posted
- 2015-11-20
- Last updated
- 2020-07-07
- Results posted
- 2020-05-14
Locations
18 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02609984. Inclusion in this directory is not an endorsement.