58 Participants Needed

Pembrolizumab for Prostate Cancer

Age: 18+
Sex: Male
Trial Phase: Phase 2
Sponsor: OHSU Knight Cancer Institute
Must be taking: LHRH agonists
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that you must continue taking enzalutamide and LHRH therapy. Some medications, like denosumab, are prohibited, and you should not have had certain treatments like chemotherapy or monoclonal antibodies recently. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the drug pembrolizumab for prostate cancer?

Pembrolizumab has shown some antitumor activity in prostate cancer, particularly in patients with specific genetic markers or PD-L1 expression. In a study, some patients with prostate cancer who were resistant to other treatments experienced significant reductions in prostate-specific antigen (PSA) levels, indicating a positive response to pembrolizumab.12345

Is pembrolizumab safe for humans?

Pembrolizumab has been used in various cancer treatments and is generally considered safe, but it can cause immune-related side effects. Some patients have experienced issues like muscle inflammation, thyroid problems, and a rare form of diabetes. These side effects are not common, but they can occur.12346

How is the drug pembrolizumab unique for treating prostate cancer?

Pembrolizumab is unique because it is an immunotherapy drug that works by blocking the PD-1 pathway, which helps the immune system recognize and attack cancer cells. This mechanism is different from traditional treatments like hormone therapy or chemotherapy, which directly target cancer cells.12378

What is the purpose of this trial?

This phase II trial studies how well pembrolizumab works in treating patients with prostate cancer that has spread to other places in the body and keeps growing even when the amount of testosterone in the body is reduced to very low levels despite previous treatment with enzalutamide. Monoclonal antibodies, such as pembrolizumab, may block tumor growth in different ways by targeting certain cells.

Research Team

JG

Julie Graff, M.D.

Principal Investigator

OHSU Knight Cancer Institute

Eligibility Criteria

This trial is for men with prostate cancer that has spread and doesn't respond to low testosterone or enzalutamide treatment. They must have good blood counts, liver and kidney function, be willing to use contraception, and not have had certain other treatments recently.

Inclusion Criteria

My kidney function is within the required range for the study.
My blood clotting time is normal or managed if I'm on blood thinners.
My prostate cancer is confirmed and not purely small cell type.
See 15 more

Exclusion Criteria

I have been diagnosed with HIV.
I do not have an active severe autoimmune disease needing strong treatment in the last 3 months.
My cancer is quickly worsening, and my doctor thinks docetaxel could help.
See 19 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Patients receive pembrolizumab IV over 30 minutes on day 1, repeating every 3 weeks for 4 courses, alongside standard of care enzalutamide

12 weeks
4 visits (in-person)

Monitoring

Patients continue to receive standard of care enzalutamide daily for the duration of the trial

Retreatment

Patients with disease response or stability receive pembrolizumab IV over 30 minutes on day 1, repeating every 3 weeks for an additional 4 courses, alongside standard of care enzalutamide

12 weeks
4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2.5 years
Every 12 weeks

Treatment Details

Interventions

  • Pembrolizumab
Trial Overview The study tests pembrolizumab's effectiveness in patients whose prostate cancer continues to grow after enzalutamide treatment. Pembrolizumab is a monoclonal antibody designed to block tumor growth by targeting specific cells.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Treatment (pembrolizumab)Experimental Treatment3 Interventions
INITIAL TREATMENT PHASE: Patients who are progressing on enzalutamide will receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients continue to receive standard of care enzalutamide PO daily. MONITORING PHASE: After completion of the initial treatment phase, patients continue to receive standard of care enzalutamide PO daily for the duration of the trial. RETREATMENT PHASE: Patients with disease response or stability after the initial treatment phase will receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for an additional 4 courses in the absence of disease progression or unacceptable toxicity. Patients continue to receive standard of care enzalutamide PO daily for the duration of the trial.

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

🇺🇸
Approved in United States as KEYTRUDA for:
  • Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
  • Melanoma
  • Non-small cell lung cancer (NSCLC)
  • Urothelial carcinoma
  • Colorectal cancer
  • Gastric cancer
  • Hepatocellular carcinoma
  • Renal cell carcinoma
  • Cervical cancer
  • Endometrial carcinoma
🇪🇺
Approved in European Union as KEYTRUDA for:
  • Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
  • Melanoma
  • Non-small cell lung cancer (NSCLC)
  • Urothelial carcinoma
  • Colorectal cancer
  • Gastric cancer
  • Hepatocellular carcinoma
  • Renal cell carcinoma
  • Cervical cancer
  • Endometrial carcinoma
🇬🇧
Approved in United Kingdom as KEYTRUDA for:
  • Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1

Find a Clinic Near You

Who Is Running the Clinical Trial?

OHSU Knight Cancer Institute

Lead Sponsor

Trials
239
Recruited
2,089,000+

Collins Medical Trust

Collaborator

Trials
6
Recruited
410+

Oregon Health and Science University

Collaborator

Trials
1,024
Recruited
7,420,000+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis profile image

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Findings from Research

In the phase II KEYNOTE-199 study involving 258 patients with metastatic castration-resistant prostate cancer (mCRPC), pembrolizumab demonstrated modest antitumor activity, with objective response rates of 5% in PD-L1-positive patients and 3% in PD-L1-negative patients, indicating some effectiveness in this challenging population.
The treatment was generally well-tolerated, with 60% of patients experiencing treatment-related adverse events, but only 5% discontinuing due to these events, suggesting that pembrolizumab has an acceptable safety profile while providing encouraging overall survival estimates, particularly in patients with bone-predominant disease.
Pembrolizumab for Treatment-Refractory Metastatic Castration-Resistant Prostate Cancer: Multicohort, Open-Label Phase II KEYNOTE-199 Study.Antonarakis, ES., Piulats, JM., Gross-Goupil, M., et al.[2021]
Pembrolizumab, a PD-1 inhibitor, has demonstrated clinical effectiveness in treating various solid tumors, particularly in patients with PD-L1-positive non-small-cell lung cancer and unresectable/metastatic melanoma.
Early-phase trials and ongoing studies are focused on further confirming the clinical benefits of pembrolizumab in thoracic malignancies, highlighting its potential as a significant treatment option in cancer therapy.
Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions.Karim, S., Leighl, N.[2017]
In a phase II trial involving 15 patients with resectable non-small cell lung cancer (NSCLC), neoadjuvant treatment with pembrolizumab showed a major pathologic response in 27% of patients, indicating promising antitumor activity before surgery.
The treatment was found to be feasible and safe, with only 33% of patients experiencing moderate adverse events, and no postoperative mortality, suggesting that pembrolizumab does not compromise surgical outcomes.
Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience.Eichhorn, F., Klotz, LV., Kriegsmann, M., et al.[2022]

References

Pembrolizumab for Treatment-Refractory Metastatic Castration-Resistant Prostate Cancer: Multicohort, Open-Label Phase II KEYNOTE-199 Study. [2021]
Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions. [2017]
Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience. [2022]
Early evidence of anti-PD-1 activity in enzalutamide-resistant prostate cancer. [2022]
Real World Experience With Pembrolizumab in Recurrent or Advanced Prostate Cancer. [2021]
Programmed Cell Death-1 Inhibitor-Induced Type 1 Diabetes Mellitus. [2022]
Acute myelomonocytic leukemia during pembrolizumab treatment for non-small cell lung cancer: A case report. [2020]
Pembrolizumab joins the anti-PD-1 armamentarium in the treatment of melanoma. [2017]
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