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
DO
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.
See 25 more
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.
See 17 more
Treatment Details
Interventions
- Leuprolide acetate (Hormone Therapy)
- Pembrolizumab (Checkpoint Inhibitor)
- Prednisone (Other)
- SD-101 (Other)
Trial OverviewThe 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
4Treatment groups
Experimental Treatment
Group I: Cohort 2: Prostate and Oligometastatic sites (ADT, SBRT, Pembrolizumab, SD-101)Experimental Treatment6 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 Treatment5 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 Treatment6 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 Treatment5 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.
Find a Clinic Near You
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
Related Searches
By Location