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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
| Astellas Pharma Inc | INDUSTRY |
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Pembrolizumab will be administered at a dose of 200 mg will be administered as a 30 minute IV infusion every 3 weeks. Enzalutamide will be administered at dose of 160 mg orally every day. All patients will be required to have at least one high-risk criteria.
The investigators propose to study the effects of pembrolizumab combined with intensive androgen receptor (AR) targeting prior to prostatectomy with extended pelvic lymph node dissection in subjects with high-risk localized prostate cancer (HRLPC).
Trial Design- single arm, single-stage, open label Phase II of neoadjuvant immune-hormonal therapy in high-risk localized prostate cancer.
Objectives To evaluate efficacy and safety of pembrolizumab combined with intensive AR targeting prior to prostatectomy in subjects with high-risk localized prostate cancer (HRLPC).
Primary Endpoint Pathologic complete response (pCR) defined as absence of detectable malignant cells in the prostatectomy specimen evaluated by standard histologic techniques.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Treatment will be planned for a total of 14 to 16 weeks. Pembrolizumab will be administered every 3 weeks via IV infusion with a dose of 200 mg per infusion. Enzalutamide will be given orally and dispensed to the patient on the date of their first infusion. The dosage of Enzalutamide will be 160 mg, administered once daily for approx. 16 weeks. GNRH agonist therapy will be administered as a standard of care therapy and will follow a standard dosage to maintain castrate levels. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pembrolizumab | Drug | Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic Complete Response | No cancer detected on pathology examination of prostatectomy specimen | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Related Adverse Events | Grade 3 or higher adverse event (AE) possibly related or related to any of three treatment drugs (pembrolizumab, enzalutamide, Gonadotropin-releasing hormone (GNRH) agonist) per CTCAE v4.03, evaluated up until 30 days after prostatectomy | 4 months + 30 days |
| Immune -related Adverse Events |
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Inclusion Criteria:
Be willing and able to provide written informed consent/assent for the trial.
Capability to understand and comply with the protocol and signed informed consent document.
Be ≥ 18 years of age on day of signing informed consent.
Have measurable disease based on RECIST 1.1.
Histologically confirmed, non-metastatic adenocarcinoma of the prostate
Prostatectomy with extended lymph node dissection planned as primary therapy
10 year or longer life expectancy based on other co-morbidities
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
Any one of the following three high risk features:
No evidence of metastases .
No other diagnosis of malignancy (with exception of non-melanoma skin cancer or a malignancy diagnosed ≥5 years ago).
Male subjects of childbearing potential must agree to use an adequate method of contraception. Contraception, starting with the first dose of study therapy through the time of surgery. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
Demonstrate adequate organ function, all screening labs should be performed within 30 days of treatment initiation.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wesley Stoller, MA | Contact | 5032208262 | 54931 | stoller@ohsu.edu |
| Mark Garzotto, MD | Contact | 5032208262 | 51982 | mark.garzotto@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| Mark Garzotto, MD | Portland VA Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Portland Healthcare System | Recruiting | Portland | Oregon | 97239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35537411 | Derived | Pala L, De Pas T, Conforti F. Boosting anticancer immunotherapy through androgen receptor blockade. Cancer Cell. 2022 May 9;40(5):455-457. doi: 10.1016/j.ccell.2022.04.007. Epub 2022 May 9. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 13, 2017 | Nov 21, 2018 | Prot_SAP_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 20, 2026 | Mar 11, 2026 | 5 |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| C565324 | Parkinson Disease 4, Autosomal Dominant Lewy Body |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| C540278 | enzalutamide |
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single arm, single-stage open label Phase II of neoadjuvant immune-hormonal therapy in high-risk Localized prostate cancer.
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| Enzalutamide | Drug | Patients will receive daily oral doses of study drug (enzalutamide 160 mg/day), which will be administered as four capsules/day to be taken at or near the same time each day. |
|
|
Grade 2 or higher immune related AE possibly related or related to any of three treatment drugs (pembrolizumab, enzalutamide, GNRH agonist) per CTCAE v4.03, evaluated up until 30 days after prostatectomy |
| 4 months + 30 days |
| Biochemical Complete Response | Prostate-Specific Antigen (PSA) < 0.1 ng/mL prior to prostatectomy | 4 months |
| Incidence of Surgical Complications | Clavien-Dindo Classification of Surgical Complications compared to historical department incidence rates. | 4 months |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |