Pembrolizumab for Prostate Cancer

(PICT-01 Trial)

Overseen By Marjorie Besançon, Ph.D

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: CHU de Quebec-Universite Laval

Must not be taking: Immunosuppressants, Steroids, others

Disqualifiers: Autoimmune disease, Pneumonitis, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

Various approaches are currently being developed for prostate cancer immunotherapy. However, a major challenge facing the development of cancer immunotherapy is the identification of tumors that would best respond to this type of treatment. Different studies suggest that prostate cancer more likely to progress are more infiltrated by exhausted T cells expressing the cell surface protein PD1 (Programmed cell death 1). Therefore, there is a strong rationale for selecting patients at higher risk of progression for testing the efficacy of anti-PD1 therapy. High glucose metabolism as detected by fludeoxyglucose F18 (FDG)-positron emission tomography (PET) (18FDG-PET) imagery is an innovative biological biomarker-based method to identify patients at higher risk of recurrence and early failure to hormonotherapy. Recent study demonstrated that high intra-prostatic 18-FDG-uptake was associated with higher Gleason grades. Therefore the one third of Gleason ≥ 8 prostate cancer patients with higher 18FDG uptake would be ideal candidates for early immunotherapy treatments based on anti-PD-1 such as pembrolizumab. The study aimed to identify biomarkers predictive the response to Pembrolizumab given prior to radical prostatectomy in participants with primary prostate cancer at high risk of progression.

Research Team

Yves Fradet, MD

Principal Investigator

CHU de Québec-Université Laval

Eligibility Criteria

Men over 18 with non-metastatic prostate cancer, Gleason score ≥8, and high glucose metabolism in the prostate as shown by PET scans. They must have good organ function, no prior hormone therapy for cancer, and be fit enough for surgery. Excluded are those with active autoimmune diseases treated within 2 years, infections needing systemic treatment, HIV or hepatitis B/C history, recent live vaccines or immunosuppressive drugs.

Inclusion Criteria

My organs are working well.

My prostate cancer is aggressive but has not spread, with a Gleason score of 8 or more.

I am scheduled for major prostate surgery within 6 to 9 weeks.

Exclusion Criteria

Is expecting to father children within the projected duration of the study, starting with the screening visit through the date of prostatectomy.

You have a history of mental health or substance abuse issues that could make it difficult to participate in the trial.

I have an autoimmune disease but haven't needed strong medication for it in the last 2 years.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 3 cycles of pembrolizumab treatment. An 18FDG-PET/CT scan is performed after the second cycle and before the third injection to assess metabolic response.

6-8 weeks

Surgery

Participants undergo radical prostatectomy and lymph node dissection 2 to 4 weeks after the third pembrolizumab treatment.

2-4 weeks

Follow-up

Participants are monitored every 3 months during the first year post-surgery and according to physician decision in subsequent years.

1 year

Treatment Details

Interventions

• Pembrolizumab

Trial Overview The trial is testing Pembrolizumab's effectiveness when given before surgical removal of the prostate in patients at high risk of cancer progression. It aims to identify biomarkers that predict how well these patients respond to this anti-PD1 immunotherapy.

Participant Groups

Group I: Prostate Cancer Experimental Treatment 1 Intervention

Participants will receive 3 cycles of pembrolizumab regardless of PD-L1 status. After completion of the second cycle of pembrolizumab treatment, and just before the third injection of pembrolizumab an 18FDG-PET/CT scan will be performed to assess a potential metabolic response. Then between 2 to 4 weeks after the third treatment, subjects will undergo radical prostatectomy. Subjects will be followed every 3 months during the first year post-surgery and according to physician decision during the following years.

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

Who Is Running the Clinical Trial?

CHU de Quebec-Universite Laval

Lead Sponsor

Trials

177

Recruited

110,000+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

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

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