MedTrace Logo

Study to Compare the Safety and Efficacy of CMB305 With Atezolizumab to Atezolizumab Alone in Participants With Sarcoma (IMDZ-C232/V943A-002)

NCT02609984 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2020-07-07

Study results available
· View outcomes & findings →

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.

Conditions

  • Sarcoma
  • Myxoid/Round Cell Liposarcoma
  • Synovial Sarcoma
  • Metastatic Sarcoma
  • Recurrent Adult Soft Tissue Sarcoma
  • Locally Advanced Sarcoma
  • Liposarcoma

Interventions

BIOLOGICAL

CMB305

A combination of LV305 administered intradermally (ID) and G305 administered intramuscularly (IM)

BIOLOGICAL

atezolizumab

IV Infusion

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

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

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-29
Primary Completion
2019-02-06
Completion
2019-02-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT02609984 on ClinicalTrials.gov