Neoadjuvant Pembrolizumab Plus Androgen Axis Blockade Prior to Prostatectomy for High Risk Localized Prostate Cancer

NCT03753243 | Unknown Phase 2 FDA Drug

• 1 other identifier: 15235
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

Neoadjuvant; Programmed cell death protein 1 (PD-1)

Outcome Measures

Primary Outcomes (1)

• Pathologic Complete Response

  No cancer detected on pathology examination of prostatectomy specimen

  4 months

Secondary Outcomes (4)

• Treatment Related Adverse Events

  4 months + 30 days

• Immune -related Adverse Events

  4 months + 30 days

• Biochemical Complete Response

  4 months

• Incidence of Surgical Complications

  4 months

Study Arms (1)

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.

Drug: Pembrolizumab; Drug: Enzalutamide

Interventions

Pembrolizumab DRUG

Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.

Also known as: Keytruda

Intervention

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.

Also known as: Xtandi

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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:
• Gleason grade \> 8-10
• PSA \> 20 ng/ml
• Clinical stage T3a (resectable)
• 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.

Sponsors & Collaborators

• Mark Garzotto, MD: lead
• Merck Sharp & Dohme LLC: collaborator
• Astellas Pharma Inc: collaborator

Study Sites (1)

VA Portland Healthcare System

Portland, Oregon, 97239, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 35537411 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Parkinson Disease 4, Autosomal Dominant Lewy Body

Interventions

pembrolizumab; enzalutamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Mark Garzotto, MD

  Portland VA Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wesley Stoller, MA

CONTACT

5032208262; stoller@ohsu.edu

Mark Garzotto, MD

CONTACT

5032208262; mark.garzotto@va.gov

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Urologic Oncology

Model Details: single arm, single-stage open label Phase II of neoadjuvant immune-hormonal therapy in high-risk Localized prostate cancer.

Study Record Dates

• First Submitted: November 20, 2018
• First Posted: November 26, 2018
• Study Start: December 3, 2018
• Primary Completion: September 3, 2022
• Study Completion: April 30, 2023
• Last Updated: April 20, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)