23 Participants Needed

Pembrolizumab + Therapy for Metastatic Prostate Cancer

JM
JO
UH
LF
Overseen ByLawrence Fong, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: David Oh
Must be taking: GnRH agonists, GnRH antagonists
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

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

DO

David Y Oh, MD, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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 24 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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Group I: Cohort 2: Prostate and Oligometastatic sites (ADT, SBRT, Pembrolizumab, SD-101)Experimental Treatment6 Interventions
Group II: Cohort 2: Prostate and Oligometastatic sites (ADT, SBRT, Pembrolizumab)Experimental Treatment5 Interventions
Group III: Cohort 1: Prostate Only Sites (ADT, SBRT, Pembrolizumab, SD-101)Experimental Treatment6 Interventions
Group IV: Cohort 1: Prostate Only Sites (ADT, SBRT, Pembrolizumab)Experimental Treatment5 Interventions

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 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

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