Clinical Trial: Durvalumab in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer

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

Official Title: Durvalumab (MEDI4736) in Hypermutated Metastatic Castration-Resistant Prostate Cancer

Brief Summary: This phase II trial studies how well durvalumab works in treating patients with prostate cancer that is resistant to hormones and has spread to other places in the body. Monoclonal antibodies, such as durvalumab, may interfere with the ability of tumor cells to grow and spread.

Detailed Summary:

PRIMARY OBJECTIVES:

I. Determine the response rate to durvalumab in metastatic castration-resistant prostate cancer (mCRPC) patients with microsatellite instability (MSI), where response rate is defined either according to modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria or a reduction in prostate specific antigen (PSA) level of >= 50%.

SECONDARY OBJECTIVES:

I. Determine the percent of mCRPC patients with MSI achieving a radiographic response per modified RECIST 1.1 criteria following treatment with durvalumab.

II. Determine the percent of mCRPC patients with MSI achieving a reduction in PSA level of >= 50% following treatment with durvalumab.

III. Determine the radiographic progression free survival (PFS) in hypermutated mCRPC patients with MSI treated with durvalumab using modified RECIST 1.1 criteria for soft tissue metastases and Prostate Cancer Working Group 3 (PCWG3) criteria for bone metastases.

IV. Determine the PSA PFS rate according to PCWG3 criteria in hypermutated mCRPC patients with MSI treated with durvalumab.

V. Determine the time to response in hypermutated mCRPC patients with MSI treated with durvalumab using modified RECIST 1.1 criteria.

VI. Determine the overall survival in hypermutated mCRPC patients with MSI treated with durvalumab.

VII. Determine the change in PSA doubling time 12-weeks after the initiation of durvalumab.

VIII. Track pain as assessed by the Brief Pain Inventor
Sponsor: University of Washington

Current Primary Outcome: Response rate to durvalumab defined according to modified RECIST 1.1 criteria or a reduction in PSA level >= 50% [ Time Frame: Up to 3 years ]

Will be calculated as the percentage with 95% confidence interval (CI) of the total number of subjects that achieved a response.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Incidence of adverse events according to NCI-CTCAE version 4.0 [ Time Frame: Up to 3 years ]
  • Overall survival [ Time Frame: From the start of treatment until death from any cause, assessed up to 3 years ]
    Will be presented with Kaplan-Meier curves, and the median survival with 95% CI will be calculated. Rates will be reported as percentages with 95% CI.
  • PSA PFS [ Time Frame: From the start of treatment until PSA progression, assessed up to 3 years ]
    Will be presented with Kaplan-Meier curves, and the median survival with 95% CI will be calculated. Rates will be reported as percentages with 95% CI.
  • PSA response rate as defined per the PCWG3 criteria [ Time Frame: Up to 3 years ]
    Will be reported as percentages with 95% CI.
  • Radiographic PFS [ Time Frame: From the start of treatment until disease progression, clinical progression, or death, whichever occurs first, assessed up to 3 years ]
    Will be presented with Kaplan-Meier curves, and the median survival with 95% CI will be calculated. Rates will be reported as percentages with 95% CI.
  • Radiographic response rate defined as CR or PR using RECIST 1.1 [ Time Frame: Up to 3 years ]
    Will be reported as percentages with 95% CI.


Original Secondary Outcome: Same as current

Information By: University of Washington

Dates:
Date Received: November 15, 2016
Date Started: January 2017
Date Completion:
Last Updated: November 15, 2016
Last Verified: November 2016