Pembrolizumab + Therapy for Metastatic Prostate Cancer

Overseen By Lawrence Fong, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: David Oh

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

Compensation: Varies

Number of Visits: 21

Duration: 9 months

23 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a non-comparative open-label multicenter Phase 2 clinical trial combining stereotactic body radiation therapy (SBRT) and pembrolizumab with or without intratumoral SD-101 in patients with newly diagnosed hormone-naive oligometastatic prostate cancer.

Research Team

David Y Oh, MD, PhD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

Men over 18 with newly diagnosed hormone-naive oligometastatic prostate cancer, who haven't had chemotherapy or surgery for it, and have fewer than four metastases. They must be able to consent, have good organ function and performance status (able to carry out daily activities), agree to use contraception, and not be on certain other treatments.

Inclusion Criteria

My cancer has spread to my bones, confirmed by a bone scan.

My hemoglobin level is at least 9 g/dL without needing transfusions or EPO recently.

Your kidney function should be measured according to the hospital's rules.

Exclusion Criteria

I have had surgery to remove my prostate.

I have been on antiandrogens for more than 2 months.

I have had radiation therapy to my prostate before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Androgen Deprivation Therapy (ADT) Run-in

Three month androgen deprivation therapy (ADT) run-in followed by leuprolide injected intramuscularly every 3 months for 3 doses

3 months

Regular visits for injections

Treatment

Participants receive pembrolizumab IV every 21 days for up to 13 doses, stereotactic body radiation therapy (SBRT) every other day over 10-14 days, and optional SD-101 injections

9 months

Pembrolizumab every 21 days, SBRT every other day for 10-14 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

15 months

Regular follow-up visits

Treatment Details

Interventions

• Leuprolide acetate
• Pembrolizumab
• Prednisone
• SD-101

Trial Overview The trial is testing the combination of radiation therapy and pembrolizumab immunotherapy with or without SD-101 injected into tumors in patients with limited-spread prostate cancer. It's an open-label Phase 2 study where everyone knows what treatment they're getting.

Participant Groups

Group I: Cohort 2: Prostate and Oligometastatic sites (ADT, SBRT, Pembrolizumab, SD-101) Experimental Treatment 6 Interventions

Three month androgen deprivation therapy (ADT) run-in followed by leuprolide injected intramuscularly every 3 months for 3 doses (or another FDA approved gonadotropin-releasing hormone agent for 9 months) + abiraterone by mouth daily with prednisone by mouth daily (or equivalent medication per local standard practice) for 9 months starting on Day 1. TLR9 agonist SD-101: Injected into the dominant prostatic tumor lesion at time of fiducial marker placement (1-5weeks prior to Cycle 1 Day 1) and 1-3 weeks after Cycle 1 Day 1 Pembrolizumab: Given IV every 21 days for up to 13 doses Radiotherapy: Given every other day over 10-14 days delivered to the whole prostate gland and oligometastatic sites via stereotactic body radiation therapy (SBRT) starting 1-2 weeks after marker placement.

Group II: Cohort 2: Prostate and Oligometastatic sites (ADT, SBRT, Pembrolizumab) Experimental Treatment 5 Interventions

Three month androgen deprivation therapy (ADT) run-in followed by leuprolide injected intramuscularly every 3 months for 3 doses (or another FDA approved gonadotropin-releasing hormone agent for 9 months) + abiraterone by mouth daily with prednisone by mouth daily (or equivalent medication per local standard practice) for 9 months starting on Day 1. Pembrolizumab: Given IV every 21 days for up to 13 doses Radiotherapy: Given every other day over 10-14 days delivered to the whole prostate gland and oligometastatic sites via stereotactic body radiation therapy (SBRT) starting 1-2 weeks after marker placement.

Group III: Cohort 1: Prostate Only Sites (ADT, SBRT, Pembrolizumab, SD-101) Experimental Treatment 6 Interventions

Three month androgen deprivation therapy (ADT) run-in followed by leuprolide injected intramuscularly every 3 months for 3 doses (or another FDA approved gonadotropin-releasing hormone agent for 9 months) + abiraterone by mouth daily with prednisone by mouth daily (or equivalent medication per local standard practice) for 9 months starting on Day 1. TLR9 agonist SD-101: Injected into the dominant prostatic tumor lesion at time of fiducial marker placement (1-5weeks prior to Cycle 1 Day 1) and 1-3 weeks after Cycle 1 Day 1 Pembrolizumab: Given IV every 21 days for up to 13 doses Radiotherapy: Given every other day over 10-14 days delivered to the whole prostate gland via stereotactic body radiation therapy (SBRT) starting 1-2 weeks after marker placement.

Group IV: Cohort 1: Prostate Only Sites (ADT, SBRT, Pembrolizumab) Experimental Treatment 5 Interventions

Three month androgen deprivation therapy (ADT) run-in followed by leuprolide injected intramuscularly every 3 months for 3 doses (or another FDA approved gonadotropin-releasing hormone agent for 9 months) + abiraterone by mouth daily with prednisone by mouth daily (or equivalent medication per local standard practice) for 9 months starting on Day 1. Pembrolizumab: Given IV every 21 days for up to 13 doses Radiotherapy: Given every other day over 10-14 days delivered to the whole prostate gland via stereotactic body radiation therapy (SBRT) starting 1-2 weeks after marker placement.

Who Is Running the Clinical Trial?

David Oh

Lead Sponsor

Trials

2

Recruited

50+

Lawrence Fong

Lead Sponsor

Trials

6

Recruited

90+

Dynavax Technologies Corporation

Industry Sponsor

Trials

30

Recruited

17,800+

TriSalus Life Sciences, Inc.

Industry Sponsor

Trials

10

Recruited

420+

Prostate Cancer Foundation

Collaborator

Trials

52

Recruited

3,000+

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