Clinical Trial: Multi-Arm Study to Test the Efficacy of Immunotherapeutic Agents in Multiple Sarcoma Subtypes

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase II Multi-Arm Study to Test the Efficacy of Immunotherapeutic Agents in Multiple Sarcoma Subtypes

Brief Summary: The goal of this clinical research study is to learn if the combination of durvalumab and tremelimumab can help to control sarcoma. The safety of this drug combination will also be studied.

Detailed Summary:

Study Drug Administration:

If you are found to be eligible to take part in this study, you will receive tremelimumab and durvalumab by vein, over about 1 hour each, every 4 weeks for up to 16 weeks (4 doses). After Week 16, you may continue to receive durvalumab alone by vein over about 1 hour for an additional 32 weeks (8 doses).

Study Visits:

On Day 1 of Week 0:

  • You will have a physical exam.
  • You will have 3 EKGs in a row.
  • Blood (about 1 tablespoon) and urine will be collected for routine tests. If you can become pregnant, part of this routine blood and urine sample will be used for a pregnancy test.
  • Blood (about 2½ tablespoons) will be drawn for biomarker and genetic testing. Biomarkers are found in the blood and may be related to your reaction to the study drug. The type of genetic testing in this study will be performed to learn how your DNA (genetic material) may change how you respond to the study drugs.

On Day 1 of Weeks 2 and 6, blood (about 3½ tablespoons) will be drawn for routine, genetic, and biomarker testing.

On Day 1 of Week 4 and then every 4 weeks after that (Weeks 8, 12, 16, and so on) until Week 44:

  • You will have a physical exam.
  • Blood (about 1 tablespoon) will be drawn for routine tests.
  • You will have imaging scans. You will not have these scans at Weeks 16 and 24.

PFS defined as evidence of stable disease or better 12 weeks after the initiation of therapy. Assessment by Response Evaluation Criteria in Solid Tumors (RECIST).



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Tumor Response [ Time Frame: 8 weeks ]
    Response assessed by the Immune Response Evaluation Criteria in Solid Tumors (irRECIST).
  • Complete Response Rate [ Time Frame: 8 weeks ]
    Response assessed by the Response Evaluation Criteria in Solid Tumors (RECIST).
  • Overall Survival (OS) [ Time Frame: 15 months ]
    OS defined as the time from treatment onset to death. OS estimated using the Kaplan-Meier method.
  • Partial Response Rate Assessed by the Immune Response Evaluation Criteria in Solid Tumors (irRECIST) [ Time Frame: 8 weeks ]
  • Partial Response Rate Assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: 8 weeks ]


Original Secondary Outcome:

  • Complete Response Rate [ Time Frame: 8 weeks ]
    Response assessed by the Immune Response Evaluation Criteria in Solid Tumors (irRECIST).
  • Complete Response Rate [ Time Frame: 8 weeks ]
    Response assessed by the Response Evaluation Criteria in Solid Tumors (RECIST).
  • Overall Survival (OS) [ Time Frame: 15 months ]
    OS defined as the time from treatment onset to death. OS estimated using the Kaplan-Meier method.
  • Partial Response Rate [ Time Frame: 8 weeks ]
    Response assessed by the Immune Response Evaluation Criteria in Solid Tumors (irRECIST).
  • Partial Response Rate [ Time Frame: 8 weeks ]
    Response assessed by the Response Evaluation Criteria in Solid Tumors (RECIST).


Information By: M.D. Anderson Cancer Center

Dates:
Date Received: June 16, 2016
Date Started: August 2016
Date Completion: August 2019
Last Updated: April 24, 2017
Last Verified: April 2017