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.
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
Interventions
Drug | Synonyms | Arms |
---|
Pembrolizumab | Keytruda | Intervention |
Enzalutamide | Xtandi | Intervention |
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
Name | Type | Description | Interventions |
---|
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. | - 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)
Last Updated
September 23, 2020