Clinical Trials /

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

NCT03753243

Description:

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.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Neoadjuvant Pembrolizumab Plus Androgen Axis Blockade Prior to Prostatectomy for High Risk Localized Prostate Cancer
  • Official Title: Phase II Study of Neoadjuvant Pembrolizumab Plus Intensive Androgen Axis Blockade Prior to Prostatectomy for High Risk Localized Prostate Cancer

Clinical Trial IDs

  • ORG STUDY ID: 15235
  • NCT ID: NCT03753243

Conditions

  • Prostate Cancer

Interventions

DrugSynonymsArms
PembrolizumabKeytrudaIntervention
EnzalutamideXtandiIntervention

Purpose

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.

Detailed Description

      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.
    

Trial Arms

NameTypeDescriptionInterventions
InterventionExperimentalTreatment 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.
  • Pembrolizumab
  • Enzalutamide

Eligibility Criteria

        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:

               -  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.

          -  Demonstrate adequate organ function, all screening labs should be performed within 30
             days of treatment initiation.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure:Pathologic Complete Response
Time Frame:4 months
Safety Issue:
Description:No cancer detected on pathology examination of prostatectomy specimen

Secondary Outcome Measures

Measure:Treatment Related Adverse Events
Time Frame:4 months + 30 days
Safety Issue:
Description: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
Measure:Immune -related Adverse Events
Time Frame:4 months + 30 days
Safety Issue:
Description: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
Measure:Biochemical Complete Response
Time Frame:4 months
Safety Issue:
Description:Prostate-Specific Antigen (PSA) < 0.1 ng/mL prior to prostatectomy
Measure:Incidence of Surgical Complications
Time Frame:4 months
Safety Issue:
Description:Clavien-Dindo Classification of Surgical Complications compared to historical department incidence rates.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Mark Garzotto, MD

Trial Keywords

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

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