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Hormone Therapy

Pembrolizumab for Prostate Cancer

Phase 2

Waitlist Available

Research Sponsored by Mark Garzotto, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 months

Awards & highlights

Study Summary

This trial will test the safety and effectiveness of two drugs, pembrolizumab and enzalutamide, in treating prostate cancer.

Eligible Conditions

Prostate Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pathologic Complete Response

Secondary outcome measures

Biochemical Complete Response

Immune -related Adverse Events

Incidence of Surgical Complications

+1 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

Trial Design

1Treatment groups

Experimental Treatment

Group I: InterventionExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

Enzalutamide

2014

Completed Phase 4

~2760

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Mark Garzotto, MDLead Sponsor

Merck Sharp & Dohme LLCIndustry Sponsor

3,886 Previous Clinical Trials

5,054,521 Total Patients Enrolled

26 Trials studying Prostate Cancer

16,965 Patients Enrolled for Prostate Cancer

Astellas Pharma IncIndustry Sponsor

691 Previous Clinical Trials

232,182 Total Patients Enrolled

35 Trials studying Prostate Cancer

8,610 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the size of the population participating in this research project?

"Affirmative. As indicated on clinicaltrials.gov, this research has been open for recruitment since December 3rd 2018 and was recently revised in April 2022. 32 participants need to be enrolled from 1 location."

Answered by AI

Are there any openings to join this scientific experiment at the current time?

"According to clinicaltrials.gov, the trial is still recruiting for participants and was initially advertised on December 3rd 2018 before undergoing a recent update on April 19th 2022."

Answered by AI

What indications have been identified for Pembrolizumab?

"Pembrolizumab can be used to treat malignant neoplasms, intractable melanomas, and microsatellite instability high cases."

Answered by AI

Has Pembrolizumab been tested in past clinical experiments?

"At the moment, 1050 active clinical trials involving pembrolizumab are ongoing; 148 of these experiments are in their third phase. Houston, Texas hosts a few of these studies while 40727 other locations across the globe have also launched investigations into this drug's efficacy."

Answered by AI

Has the Food and Drug Administration sanctioned Pembrolizumab for use?

"Clinical evidence exists to suggest that pembrolizumab is safe, resulting in it being given a score of 2. However, the data suggesting its efficacy still needs to be evaluated."

Answered by AI

Recent research and studies

Cancer CellJournal

Boosting Anticancer Immunotherapy Through Androgen Receptor Blockade

Pala, Laura, Tommaso De Pas, and Fabio Conforti. 2022. “Boosting Anticancer Immunotherapy Through Androgen Receptor Blockade”. Cancer Cell. Elsevier BV. doi:10.1016/j.ccell.2022.04.007.

clinicaltrials.govStudy

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

Mark Garzotto, MD 2018. "Neoadjuvant Pembrolizumab Plus Androgen Axis Blockade Prior to Prostatectomy for High Risk Localized Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03753243.