← Back to Search

PD-L1 Inhibitor

Durvalumab + Olaparib for Prostate Cancer

Phase 2
Waitlist Available
Led By Michael Schweizer
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
PSA >= 2 ng/ml if received only prior definitive radiation (no PSA threshold required if prior prostatectomy was performed) with a PSA doubling time (PSADT) =< 10 months
Prior salvage radiation or not a candidate for localized salvage radiation due to subject preference or clinical assessment based upon disease characteristics and/or subject co-morbidities
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 3 and 6 months
Awards & highlights

Study Summary

This trial is testing the combination of two drugs, durvalumab and olaparib, to treat prostate cancer in men with specific genetic mutations.

Who is the study for?
Men with prostate cancer who've had local therapy, a rising PSA level, and no metastatic disease on scans. They must have specific genetic mutations indicating a high neoantigen load, not received certain prior treatments like chemotherapy or immunotherapy, and can't be immunocompromised. Participants need to be over 18 years old with an ECOG performance status of =<1 (able to carry out light activity), adequate organ function, and willing to use contraception.Check my eligibility
What is being tested?
The trial is testing the combination of durvalumab (an immune system-boosting monoclonal antibody) and olaparib (a PARP inhibitor that prevents cancer cells from repairing their DNA) in men whose prostate cancer has specific genetic features suggesting they might respond well to these drugs.See study design
What are the potential side effects?
Durvalumab may cause immune-related side effects such as inflammation in various organs or infusion reactions. Olaparib could lead to blood cell count changes, nausea, fatigue, digestive issues. Side effects vary by individual.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My PSA is at least 2 ng/ml after radiation, or I've had a prostatectomy. My PSA doubles in 10 months or less.
Select...
I either had salvage radiation before or am not suitable for it due to my health or choice.
Select...
My scans show no signs of cancer spread beyond the original site.
Select...
I will use a condom during and for 3 months after treatment if my partner could become pregnant.
Select...
My kidneys are functioning well, with a creatinine clearance rate of at least 51 mL/min.
Select...
My cancer has specific genetic changes.
Select...
I am able to understand and sign the consent form.
Select...
I stopped hormonal therapy over 6 months ago and my testosterone is above 150 ng/dl.
Select...
My body weight is over 30 kg.
Select...
I have had surgery or radiation for prostate cancer.
Select...
My prostate cancer is confirmed to be adenocarcinoma.
Select...
My cancer has spread to 3 or fewer places, as shown by advanced scans.
Select...
I am older than 18 years.
Select...
I can carry out all my self-care activities without assistance.
Select...
My hemoglobin level is at least 10.0 g/dL without recent blood transfusions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 3 and 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 3 and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Undetectable prostate specific antigen (PSA)
Secondary outcome measures
Change in quality of life: IIEF
Change in quality of life: RANDSF-36
Incidence of AEs during durvalumab and olaparib combination therapy
+2 more

Side effects data

From 2022 Phase 2 trial • 80 Patients • NCT03015129
65%
Fatigue
63%
Abdominal pain
55%
Diarrhea
43%
Pain
40%
Weight loss
35%
Hypertension
30%
Anorexia
30%
Constipation
28%
Nausea
28%
Pruritus
25%
Vomiting
20%
Urinary tract infection
20%
Dyspnea
18%
Rash maculo-papular
15%
Abdominal Pain
15%
Back pain
15%
Weight gain
15%
Cough
15%
Increased Urinary Frequency
13%
Arthralgia
10%
Dizziness
10%
Anxiety
10%
Bladder infection
10%
Nasal congestion
10%
Vaginal discharge
8%
Anal pain
8%
Dry skin
8%
Urinary frequency
8%
Edema limbs
8%
Flatulence
8%
Myalgia
8%
Hot flashes
8%
Thromboembolic event
8%
Fever
8%
Colitis
8%
Dry mouth
8%
Headache
8%
Small intestinal obstruction
8%
Urinary tract pain
5%
Ascites
5%
Lymphedema
5%
Memory impairment
5%
Mucositis oral
5%
Pneumonitis
5%
Confusion
5%
Gastroesophageal reflux disease
5%
Anemia
5%
Urinary urgency
5%
Vaginal hemorrhage
5%
Sinus bradycardia
5%
Hypomagnesemia
5%
Rash acneiform
5%
Renal and urinary disorders - Other, specify
5%
Adrenal insufficiency
5%
Upper respiratory infection
3%
Rectal hemorrhage
3%
CPK increased
3%
Fall
3%
Skin infection
3%
Muscle weakness left-sided
3%
Myositis
3%
Hyperglycemia
3%
Peripheral sensory neuropathy
3%
Colonic perforation
3%
Pain in extremity
3%
Blood bilirubin increased
3%
Rectal pain
3%
Weight Loss
3%
Alanine aminotransferase increased
3%
Aspartate aminotransferase increased
3%
Alkaline phosphatase increased
3%
Creatinine increased
3%
Lethargy
3%
Left ventricular systolic dysfunction
3%
Dysarthria
3%
Hypothyroidism
3%
Myocarditis
3%
Pleural effusion
3%
Hyperkalemia
3%
Generalized muscle weakness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalubmab
Durvalubmab + Tremelimumab

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (durvalumab, olaparib)Experimental Treatment4 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
2007
Completed Phase 4
~2140
Durvalumab
2017
Completed Phase 2
~3870

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,724 Previous Clinical Trials
1,821,381 Total Patients Enrolled
18 Trials studying Prostate Cancer
8,244 Patients Enrolled for Prostate Cancer
AstraZenecaIndustry Sponsor
4,237 Previous Clinical Trials
288,449,669 Total Patients Enrolled
60 Trials studying Prostate Cancer
27,488 Patients Enrolled for Prostate Cancer
Michael SchweizerPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
10 Previous Clinical Trials
138 Total Patients Enrolled
1 Trials studying Prostate Cancer
20 Patients Enrolled for Prostate Cancer

Media Library

Durvalumab (PD-L1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04336943 — Phase 2
Prostate Cancer Research Study Groups: Treatment (durvalumab, olaparib)
Prostate Cancer Clinical Trial 2023: Durvalumab Highlights & Side Effects. Trial Name: NCT04336943 — Phase 2
Durvalumab (PD-L1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04336943 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the most recent findings from other tests using Durvalumab?

"As of now, there are 497 ongoing studies investigating Durvalumab with 74 in Phase 3. While a significant number of these research projects are based in Houston, Texas; there are actually 20,974 locations conducting trials for Durvalumab."

Answered by AI

Are we still seeking participants for this research?

"Yes, this trial is still recruiting patients according to the latest update on clinicaltrials.gov from November 8th, 2022. The initial posting was on April 13th, 2021."

Answered by AI

Are there any dangers associated with Durvalumab treatments?

"Because Durvalumab is only in Phase 2 clinical trials, there is not yet enough evidence to support its efficacy. However, it has been deemed somewhat safe and received a score of 2."

Answered by AI

How many people are enrolled in the research project?

"Yes, as indicated on the clinicaltrials.gov website, this study is currently looking for 30 participants from 1 site. The trial was first posted on 4/13/2021 and last updated on 11/8/2022."

Answered by AI

Have there been similar tests like this one in the past?

"As of now, 497 studies regarding Durvalumab are ongoing in 65 different countries and 1844 cities. The first clinical trial for this medication was back in 2005 and involved 98 patients. It completed Phase 1 drug approval. In the 15 years since then, 395 more studies have been undertaken."

Answered by AI

What are the primary indications for Durvalumab?

"Durvalumab is an effective pharmacotherapy for treating primary peritoneal cancer, as well as disease and other cancers."

Answered by AI
~0 spots leftby Jun 2024