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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests pembrolizumab (also known as KEYTRUDA or MK-3475), a treatment designed to enhance the body's immune response against prostate cancer. The focus is on patients with primary prostate cancer at high risk of progression, particularly those with a Gleason score of 8 or higher and high sugar use in their prostate cells. Participants will receive three cycles of pembrolizumab and undergo a special scan to monitor changes before surgery. Candidates who have not received hormone treatments and show high sugar use on the scan may qualify for this trial. As a Phase 2 trial, this research aims to measure the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant advancements in prostate cancer treatment.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot be on androgen deprivation therapy or have received certain cancer treatments recently. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that pembrolizumab is likely to be safe for humans?

Research has shown that pembrolizumab is generally well-tolerated by people with prostate cancer. One study found that pembrolizumab alone is safe for certain patients, with most experiencing no severe side effects. Common side effects include fatigue, nausea, and skin rash, while serious side effects are rare.

Another study found that combining pembrolizumab with chemotherapy for prostate cancer results in manageable side effects. Although side effects may occur, they are not usually severe enough to halt treatment.

Overall, pembrolizumab has been tested in many people and is considered safe for most. However, like any treatment, potential risks exist, and discussing these with a doctor before joining a trial is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for prostate cancer?

Pembrolizumab is unique because it leverages the body's immune system to fight prostate cancer by targeting the PD-1/PD-L1 pathway. Unlike traditional treatments like hormone therapy, chemotherapy, or surgery, pembrolizumab is an immunotherapy that can potentially activate the immune system to recognize and attack cancer cells more effectively. Researchers are excited about pembrolizumab because it offers a novel mechanism of action that might provide benefits even for patients whose cancers do not respond well to existing treatments. Additionally, pembrolizumab could potentially lead to a more durable response, maintaining effectiveness over a longer period compared to some conventional therapies.

What evidence suggests that pembrolizumab might be an effective treatment for prostate cancer?

Research shows that pembrolizumab, the treatment under study in this trial, may effectively treat prostate cancer, particularly in patients with high-risk factors. Studies have found significant improvements in patients with advanced prostate cancer who received pembrolizumab. Early results also indicate quick reductions in disease markers for patients unresponsive to other treatments. This treatment targets a protein called PD1 on T cells, which can become "tired" in fighting cancer. Pembrolizumab reactivates these cells to attack the tumor. These findings strongly support using pembrolizumab for patients with aggressive prostate cancer, potentially leading to better outcomes. ^{1 2 3 6 7}

Who Is on the Research Team?

Yves Fradet, MD

Principal Investigator

CHU de Québec-Université Laval

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1558767325000849

Clinical Outcomes of Patients With Metastatic Prostate ... Treatment with pembrolizumab led to a significant rate of biochemical and radiographic response in a heavily pre-treated cohort of MSI-H metastatic prostate ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7186583/

Pembrolizumab for Treatment-Refractory Metastatic Castration ... Initial results from the first 10 patients with enzalutamide-resistant mCRPC who were treated with pembrolizumab in a phase II study showed a rapid decrease in ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02861573

NCT02861573 | Study of Pembrolizumab (MK-3475) ... The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combination therapy in participants with metastatic castration ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.6_suppl.165

Updated results of a phase Ib single-center study ... This study evaluated the safety and efficacy signals of pembrolizumab and chemotherapy in patients with small cell/neuroendocrine cancer of the prostate and ...

5. annalsofoncology.org annalsofoncology.org/article/S0923-7534(25)00199-1/fulltext

the randomized, double-blind, phase III KEYNOTE-641 study The PSA response rate (95% CI) was 49.0% (44.9% to 53.1%) with pembrolizumab plus enzalutamide versus 45.1% (41.1% to 49.2%) with placebo plus ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11892552/

Response to pembrolizumab in advanced prostate cancer ... We found that 38.9% of patients showed a 50% or greater decline in PSA, all of whom had high microsatellite instability (MSI-H). One patient ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02787005

NCT02787005 | Study of Pembrolizumab (MK-3475) in ... This is a study of pembrolizumab (MK-3475) in participants with metastatic castration-resistant prostate cancer (mCRPC).