Durvalumab and Olaparib for the Treatment of Prostate Cancer in Men Predicted to Have a High Neoantigen Load
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|ClinicalTrials.gov Identifier: NCT04336943|
Recruitment Status : Recruiting
First Posted : April 7, 2020
Last Update Posted : January 11, 2022
|Condition or disease||Intervention/treatment||Phase|
|Biochemically Recurrent Prostate Carcinoma Prostate Adenocarcinoma||Biological: Durvalumab Drug: Olaparib Other: Quality-of-Life Assessment Other: Questionnaire Administration||Phase 2|
All patients receive durvalumab IV over 1 hour on day 1 of each cycle, total 6 cycles. Starting cycle 4, patients with CDK12 mutations and mismatch repair deficiency (MMRd)/microsatellite instability (MSI)-high will also receive olaparib orally (PO) twice daily (BID) on days 1- 28 of cycles 4-6. Patients with homologous recombination mutation will also receive olaparib PO BID on days 1-28 of cycles 1-6. Cycles repeat every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 2 weeks, and then every 12 weeks to complete 24 months (at 9, 12, 15, 18, 21 and 24 months).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Durvalumab (MEDI4736) and Olaparib (AZD2281) for Treatment of Biochemically Recurrent Prostate Cancer in Men Predicted to Have a High Neoantigen Load: A Pilot Study|
|Actual Study Start Date :||April 13, 2021|
|Estimated Primary Completion Date :||April 30, 2023|
|Estimated Study Completion Date :||April 30, 2024|
Experimental: Treatment (durvalumab, olaparib)
All patients receive durvalumab IV over 1 hour on day 1 of each cycle. Patients with CDK12 mutation and MMRd/MSI-high also receive olaparib PO BID on days 1- 28 of cycles 3-6. Patients with homologous recombination mutation also receive olaparib PO BID on days 1-28 of cycles 1-6. Cycles repeat every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity.
Other: Quality-of-Life Assessment
Other Name: Quality of Life Assessment
Other: Questionnaire Administration
- Undetectable prostate specific antigen (PSA) [ Time Frame: At 12 months after initiation of therapy ]Will assess if patients achieve undetectable PSA for post-prostatectomy patients (including those that also received salvage radiation) or PSA < 0.5 ng/ml for post-definitive radiation patients.
- Incidence of adverse events (AEs) during durvalumab monotherapy [ Time Frame: Up to 3 months ]Will be assessed per Common Terminology Criteria for Adverse Events CTCAE version (v) 5.0 guidelines.
- Incidence of AEs during durvalumab and olaparib combination therapy [ Time Frame: Up to 6 months ]Will be assessed per CTCAE v5.0 guidelines.
- PSA50 response [ Time Frame: At 3 and 6 months ]A descriptive summary (including the percentage and 90% confidence interval [CI]) of PSA50 response rate (proportion of patients with a decline in PSA > 50% from baseline) will be provided at 3- and 6-month timepoints. The response rate will be reported with exact binomial two-sided 90% CI.
- Change in quality of life: RANDSF-36 [ Time Frame: At the time of enrollment and then every three months for 24 months ]Will be assessed using the RANDSF-36 score calculation
- Change in quality of life: IIEF [ Time Frame: At the time of enrollment and then every three months for 24 months ]Will be assessed using the International Index of Erectile Function (IIEF) score calculation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04336943
|Contact: Michael Schweizerfirstname.lastname@example.org|
|United States, Washington|
|Fred Hutch/University of Washington Cancer Consortium||Recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Michael Schweizer 206-606-6252 email@example.com|
|Principal Investigator: Michael Schweizer|
|Principal Investigator:||Michael Schweizer||Fred Hutch/University of Washington Cancer Consortium|