Clinical Trial: Avelumab and Trabectedin in Treating Patients With Liposarcoma or Leiomyosarcoma That is Metastatic or Cannot Be Removed by Surgery

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Phase I/II Trial Combining Avelumab and Trabectedin for Advanced Liposarcoma and Leiomyosarcoma

Brief Summary: This phase I/II studies the side effects of avelumab and trabectedin and how well they work in treating patients with leiomyosarcoma or liposarcoma that has spread to other places in the body or cannot be removed by surgery. Monoclonal antibodies, such as avelumab, may block tumor growth in different ways by targeting certain cells. Drugs used in chemotherapy, such as trabectedin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving avelumab and trabectedin may work better in treating patients with liposarcoma or leiomyosarcoma.

Detailed Summary:

PRIMARY OBJECTIVES:

I. To assess the safety and tolerability of the combination of trabectedin and avelumab in patients with advanced leiomyosarcoma and liposarcomas (L-type sarcomas).

II. To assess the objective response rate of advanced L-type sarcoma patients receiving the combination of avelumab and trabectedin.

SECONDARY OBJECTIVES:

I. To explore the clinical activity of avelumab and trabectedin with respect to time to response.

II. To explore the clinical activity of avelumab and trabectedin with respect to duration of response.

III. To explore the clinical activity of avelumab and trabectedin with respect to progression-free survival (PFS) at 12 weeks.

IV. To explore the clinical activity of avelumab and trabectedin with respect to clinical benefit rate (complete response [CR]+ partial response [PR]+ stable disease [SD]) at 12 weeks.

V. To explore the clinical activity of avelumab and trabectedin with respect to overall survival.

OUTLINE:

Patients receive avelumab intravenously (IV) over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients also receive trabectedin IV over 24 hours on day 1. Courses repeat every 3 weeks and may repeat up to every 5 weeks after 2 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 12 weeks fo
Sponsor: Fred Hutchinson Cancer Research Center

Current Primary Outcome: Incidence of adverse events [ Time Frame: Up to 30 days ]

Measured by Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4.03


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Time to response [ Time Frame: Up to 2 years ]
    Assessed by Response Evaluation Criteria in Solid Tumors 1.1
  • Duration of response [ Time Frame: Up to 2 years ]
    Assessed by Response Evaluation Criteria in Solid Tumors 1.1
  • Progression-free survival [ Time Frame: At 12 weeks ]
    Assessed by Response Evaluation Criteria in Solid Tumors 1.1
  • Complete response rate (CR) [ Time Frame: At 12 weeks ]
    Assessed by Response Evaluation Criteria in Solid Tumors 1.1
  • Partial response rate (PR) [ Time Frame: At 12 weeks ]
    Assessed by Response Evaluation Criteria in Solid Tumors 1.1
  • Stable disease (SD) [ Time Frame: At 12 weeks ]
    Assessed by Response Evaluation Criteria in Solid Tumors 1.1
  • Clinical benefit rate (percentage of patients who achieve CR+PR+SD) [ Time Frame: At 12 weeks ]
    Assessed by Response Evaluation Criteria in Solid Tumors 1.1
  • Overall survival [ Time Frame: Up to 2 years ]
    Assessed by Response Evaluation Criteria in Solid Tumors 1.1


Original Secondary Outcome: Same as current

Information By: Fred Hutchinson Cancer Research Center

Dates:
Date Received: March 1, 2017
Date Started: April 15, 2017
Date Completion: March 15, 2020
Last Updated: March 3, 2017
Last Verified: March 2017