Trial Outcomes & Findings for Durvalumab and Olaparib for the Treatment of Prostate Cancer in Men Predicted to Have a High Neoantigen Load (NCT NCT04336943)

NCT ID: NCT04336943

Last Updated: 2025-08-11

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 6 participants
• Primary outcome timeframe: At 12 months after initiation of therapy
• Results posted on: 2025-08-11

Participant Flow

Participant milestones

Measure	Treatment (Durvalumab, Olaparib) - CDK12 and MMRd 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. Durvalumab: Given IV Olaparib: Given PO Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies	Treatment (Durvalumab, Olaparib) - HRD 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. Durvalumab: Given IV Olaparib: Given PO Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
Overall Study STARTED	1	5
Overall Study COMPLETED	1	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Durvalumab and Olaparib for the Treatment of Prostate Cancer in Men Predicted to Have a High Neoantigen Load

Baseline characteristics by cohort

Measure	Treatment (Durvalumab, Olaparib) n=6 Participants 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. Durvalumab: Given IV Olaparib: Given PO Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Note: All patients enrolled received combo therapy, so demographic data are provided in aggregate. Also, given the small number of enrolled subjects reporting demographics for the entire group is preferred.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Treatment (Durvalumab, Olaparib) - CDK12 and MMRd n=1 Participants 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. Durvalumab: Given IV Olaparib: Given PO Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies	Treatment (Durvalumab, Olaparib) - HRD n=5 Participants 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. Durvalumab: Given IV Olaparib: Given PO Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
Undetectable Prostate Specific Antigen (PSA)	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Treatment (Durvalumab, Olaparib) - CDK12 and MMRd n=1 Participants 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. Durvalumab: Given IV Olaparib: Given PO Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies	Treatment (Durvalumab, Olaparib) - HRD n=5 Participants 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. Durvalumab: Given IV Olaparib: Given PO Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
PSA50 Response	0 Participants	3 Participants

SECONDARY outcome

Timeframe: At the time of enrollment and then every three months, with the last assessment at 12 months.

RAND 36-Item Short Form (RANDSF-36) assesses physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, general health perceptions, and perceived change in health with a total score range of 0-100. The total score from all of the questions answered is divided by the total number of the questions answered yielding a global score from 0-100, with a higher score reflecting a better QoL. Mean difference in total average score is reported. Since the same treatment is used for all groups, we are reporting the data for RANDSF-36 in aggregate. Because this study terminated prematurely, the small number of enrolled subjects also preclude our ability to break this data at by subgroups.

Outcome measures

Measure	Treatment (Durvalumab, Olaparib) - CDK12 and MMRd n=2 Participants 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. Durvalumab: Given IV Olaparib: Given PO Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies	Treatment (Durvalumab, Olaparib) - HRD 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. Durvalumab: Given IV Olaparib: Given PO Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
Change in Quality of Life: RANDSF-36	4.64 Scores on a scale Interval -1.14 to 10.42	—

SECONDARY outcome

Timeframe: At the time of enrollment and then every three months, with the final measurement after 12 months.

International Index of Erectile Function (IIEF-5) is a diagnostic tool for erectile dysfunction, with a total score range of 5-25, with the lowest score indicating a higher degree of dysfunction. The mean difference in total score is reported. Since the same treatment is used for all groups, we are reporting the data for RANDSF-36 in aggregate. Because this study terminated prematurely, the small number of enrolled subjects also preclude our ability to break this data at by subgroups.

Outcome measures

Measure	Treatment (Durvalumab, Olaparib) - CDK12 and MMRd n=2 Participants 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. Durvalumab: Given IV Olaparib: Given PO Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies	Treatment (Durvalumab, Olaparib) - HRD 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. Durvalumab: Given IV Olaparib: Given PO Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
Change in Quality of Life: IIEF	-9 Scores on a scale Interval -15.0 to -3.0	—

Adverse Events

Treatment (Durvalumab, Olaparib)

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure

Treatment (Durvalumab, Olaparib) n=6 participants at risk 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. Durvalumab: Given IV Olaparib: Given PO Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies

Infections and infestations Rash Pustular

16.7% 1/6 • Number of events 1 • 90 days after the last dose of durvalumab or 30 days from last dose of olaparib, whatever comes later, up to 9 months. Note: Data is reported in aggregate since all patient received the same combination therapy. In addition, the small sample size due to early termination precludes breaking out the AEs by subgroup.

Other adverse events

Measure	Treatment (Durvalumab, Olaparib) n=6 participants at risk 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. Durvalumab: Given IV Olaparib: Given PO Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
Vascular disorders Hot Flashes	16.7% 1/6 • Number of events 1 • 90 days after the last dose of durvalumab or 30 days from last dose of olaparib, whatever comes later, up to 9 months. Note: Data is reported in aggregate since all patient received the same combination therapy. In addition, the small sample size due to early termination precludes breaking out the AEs by subgroup.
Respiratory, thoracic and mediastinal disorders Dyspnea	50.0% 3/6 • Number of events 3 • 90 days after the last dose of durvalumab or 30 days from last dose of olaparib, whatever comes later, up to 9 months. Note: Data is reported in aggregate since all patient received the same combination therapy. In addition, the small sample size due to early termination precludes breaking out the AEs by subgroup.
Respiratory, thoracic and mediastinal disorders Pneumonitis	16.7% 1/6 • Number of events 1 • 90 days after the last dose of durvalumab or 30 days from last dose of olaparib, whatever comes later, up to 9 months. Note: Data is reported in aggregate since all patient received the same combination therapy. In addition, the small sample size due to early termination precludes breaking out the AEs by subgroup.
Nervous system disorders Dizziness	50.0% 3/6 • Number of events 3 • 90 days after the last dose of durvalumab or 30 days from last dose of olaparib, whatever comes later, up to 9 months. Note: Data is reported in aggregate since all patient received the same combination therapy. In addition, the small sample size due to early termination precludes breaking out the AEs by subgroup.
Nervous system disorders Headache	50.0% 3/6 • Number of events 3 • 90 days after the last dose of durvalumab or 30 days from last dose of olaparib, whatever comes later, up to 9 months. Note: Data is reported in aggregate since all patient received the same combination therapy. In addition, the small sample size due to early termination precludes breaking out the AEs by subgroup.
Gastrointestinal disorders Nausea	50.0% 3/6 • Number of events 4 • 90 days after the last dose of durvalumab or 30 days from last dose of olaparib, whatever comes later, up to 9 months. Note: Data is reported in aggregate since all patient received the same combination therapy. In addition, the small sample size due to early termination precludes breaking out the AEs by subgroup.
General disorders Fatigue	83.3% 5/6 • Number of events 5 • 90 days after the last dose of durvalumab or 30 days from last dose of olaparib, whatever comes later, up to 9 months. Note: Data is reported in aggregate since all patient received the same combination therapy. In addition, the small sample size due to early termination precludes breaking out the AEs by subgroup.
Respiratory, thoracic and mediastinal disorders Wheezing	16.7% 1/6 • Number of events 1 • 90 days after the last dose of durvalumab or 30 days from last dose of olaparib, whatever comes later, up to 9 months. Note: Data is reported in aggregate since all patient received the same combination therapy. In addition, the small sample size due to early termination precludes breaking out the AEs by subgroup.
Gastrointestinal disorders Diarrhea	16.7% 1/6 • Number of events 1 • 90 days after the last dose of durvalumab or 30 days from last dose of olaparib, whatever comes later, up to 9 months. Note: Data is reported in aggregate since all patient received the same combination therapy. In addition, the small sample size due to early termination precludes breaking out the AEs by subgroup.
Nervous system disorders Dysgeusia	16.7% 1/6 • Number of events 1 • 90 days after the last dose of durvalumab or 30 days from last dose of olaparib, whatever comes later, up to 9 months. Note: Data is reported in aggregate since all patient received the same combination therapy. In addition, the small sample size due to early termination precludes breaking out the AEs by subgroup.
General disorders Pain	16.7% 1/6 • Number of events 1 • 90 days after the last dose of durvalumab or 30 days from last dose of olaparib, whatever comes later, up to 9 months. Note: Data is reported in aggregate since all patient received the same combination therapy. In addition, the small sample size due to early termination precludes breaking out the AEs by subgroup.
Gastrointestinal disorders Constipation	33.3% 2/6 • Number of events 2 • 90 days after the last dose of durvalumab or 30 days from last dose of olaparib, whatever comes later, up to 9 months. Note: Data is reported in aggregate since all patient received the same combination therapy. In addition, the small sample size due to early termination precludes breaking out the AEs by subgroup.
Gastrointestinal disorders Stomach Pain	16.7% 1/6 • Number of events 1 • 90 days after the last dose of durvalumab or 30 days from last dose of olaparib, whatever comes later, up to 9 months. Note: Data is reported in aggregate since all patient received the same combination therapy. In addition, the small sample size due to early termination precludes breaking out the AEs by subgroup.
Gastrointestinal disorders Gastroesophageal Reflux Disease	16.7% 1/6 • Number of events 1 • 90 days after the last dose of durvalumab or 30 days from last dose of olaparib, whatever comes later, up to 9 months. Note: Data is reported in aggregate since all patient received the same combination therapy. In addition, the small sample size due to early termination precludes breaking out the AEs by subgroup.

Additional Information

Dr. Michael Schweizer

Fred Hutchinson Cancer Center

Phone: 2066066252

Email: mtschwei@fredhutch.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place