Clinical Trial: Trial of CMB305 and Atezolizumab in Patients With Sarcoma
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: 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
Brief Summary:
This is an open-label Phase 2 randomized study that will examine the use of the study agents, CMB305 (sequentially administered LV305 [a dendritic cell-targeting viral vector expressing the NY-ESO-1 gene] and G305 [NY-ESO-1 recombinant protein plus GLA-SE]) in combination with atezolizumab or atezolizumab alone, in patients with locally advanced, relapsed or metastatic sarcoma (synovial or myxoid/round cell liposarcoma) expressing the NY-ESO-1 protein.
CMB305 is a novel approach designed to stimulate the body's immune system to fight the spread and growth of cancer in patients whose tumors express the NY-ESO-1 protein. LV305 will be given in a prime-boost approach with G305 to induce a potentially synergistic immunotherapeutic response in combination with atezolizumab.
Detailed Summary: This study is designed to investigate and examine the time to progression for CMB305 in combination with atezolizumab or atezolizumab alone in the treatment of patients with sarcoma expressing NY-ESO-1 protein.
Sponsor: Immune Design
Current Primary Outcome: Progression Free Survival [ Time Frame: Up to 2 years after first study injection ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Safety as Evaluated by Adverse Events, Laboratory Findings and Patient Discontinuations [ Time Frame: Up to 2 years after first study injection ]Safety of CMB305 in combination with atezolizumab or atezolizumab alone will be assessed by the following measures. Adverse events and serious adverse events,(according to CTCAE v4.03); laboratory findings and patient discontinuations at all timepoints will be evaluated. Study deaths and adverse events (serious and non-serious) that lead to discontinuation will be evaluated.
- Progression Free Survival Rates [ Time Frame: Up to six months after first study injection ]Progression-free survival rates at 3 and 6 months after start of study treatment
- Best Overall Response Rate [ Time Frame: Up to 2 years after first study injection ]Best overall response rate (ORR; by Response Evaluation Criteria in Solid Tumors [RECIST] v1.1 modified to use immune-related Response Criteria [irRC]) and response duration up to 24 months after starting treatment
- Overall Survival [ Time Frame: Up to 2 years after first study injection ]Overall survival (OS) after CMB305 in combination with atezolizumab or with atezolizumab alone
Original Secondary Outcome: Same as current
Information By: Immune Design
Dates:
Date Received: November 14, 2015
Date Started: October 2015
Date Completion: July 2019
Last Updated: February 28, 2017
Last Verified: December 2016