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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

Male patients must use a condom during treatment and for 3 months after the last dose of olaparib when having sexual intercourse with a pregnant woman or with a woman of childbearing potential

Must not have

Patients with myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of MDS/AML

Any prior treatment with a PARP inhibitor, including olaparib

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 3 and 6 months

Awards & highlights

No Placebo-Only Group

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.

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.

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

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My PSA is at least 2 ng/ml after radiation, or I've had a prostatectomy. My PSA doubles in 10 months or less.

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I will use a condom during and for 3 months after treatment if my partner could become pregnant.

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My kidneys are functioning well, with a creatinine clearance rate of at least 51 mL/min.

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My cancer has specific genetic changes.

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I stopped hormonal therapy over 6 months ago and my testosterone is above 150 ng/dl.

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My body weight is over 30 kg.

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I have had surgery or radiation for prostate cancer.

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My prostate cancer is confirmed to be adenocarcinoma.

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My cancer has spread to 3 or fewer places, as shown by advanced scans.

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I can carry out all my self-care activities without assistance.

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My hemoglobin level is at least 10.0 g/dL without recent blood transfusions.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.

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I have never been treated with a PARP inhibitor like olaparib.

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I do not have any serious, uncontrolled health issues or infections.

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I am not taking strong or moderate CYP3A inhibitors.

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I have had cancer spread to the lining of my brain and spinal cord.

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I have had a bone marrow or cord blood transplant in the past.

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I had major surgery more than 2 weeks ago and have recovered.

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My heart condition is stable and does not include uncontrolled issues or long QT syndrome.

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I cannot swallow pills or have stomach issues affecting medication absorption.

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I do not have an active infection like TB or hepatitis.

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I am not taking any strong or moderate drugs that affect liver enzymes.

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I haven't had extensive radiation to my bone marrow or wide field radiation in the last 4 weeks.

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I have previously been treated with a PD1 or PD-L1 inhibitor.

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I have not received a live vaccine within the last 30 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 3 and 6 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Undetectable prostate specific antigen (PSA)

Secondary study objectives

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%

Dyspnea

20%

Urinary tract infection

18%

Rash maculo-papular

15%

Cough

15%

Abdominal Pain

15%

Back pain

15%

Increased Urinary Frequency

15%

Weight gain

13%

Arthralgia

10%

Dizziness

10%

Anxiety

10%

Bladder infection

10%

Nasal congestion

10%

Vaginal discharge

Colitis

Dry mouth

Dry skin

Fever

Anal pain

Edema limbs

Flatulence

Headache

Hot flashes

Myalgia

Small intestinal obstruction

Thromboembolic event

Urinary frequency

Urinary tract pain

Confusion

Renal and urinary disorders - Other, specify

Adrenal insufficiency

Anemia

Ascites

Gastroesophageal reflux disease

Hypomagnesemia

Lymphedema

Memory impairment

Mucositis oral

Pneumonitis

Rash acneiform

Sinus bradycardia

Upper respiratory infection

Urinary urgency

Vaginal hemorrhage

Alanine aminotransferase increased

Aspartate aminotransferase increased

Alkaline phosphatase increased

Colonic perforation

Dysarthria

Blood bilirubin increased

CPK increased

Creatinine increased

Myositis

Rectal hemorrhage

Hypothyroidism

Left ventricular systolic dysfunction

Lethargy

Muscle weakness left-sided

Myocarditis

Rectal pain

Weight Loss

Fall

Generalized muscle weakness

Hyperglycemia

Hyperkalemia

Pain in extremity

Peripheral sensory neuropathy

Pleural effusion

Skin infection

100%

80%

60%

40%

20%

Study treatment Arm

Durvalubmab

Durvalubmab + Tremelimumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2190

Durvalumab

2017

Completed Phase 2

~3750