Pembrolizumab + Therapy for Metastatic Prostate Cancer

Palo Alto (17 mi)

Overseen byDavid Y Oh, MD, PhD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: David Oh

No Placebo Group

Prior Safety Data

Breakthrough Therapy

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.

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

My kidney function, measured by creatinine or GFR, is within the normal range.

I have not had surgery or radiation for prostate cancer.

I have not had chemotherapy for my prostate cancer.

I cannot or choose not to undergo chemotherapy.

My testosterone was over 150 ng/dL before starting hormone therapy.

My liver enzymes are within the required limits.

My cancer has spread to less than 4 places in my bones or lymph nodes.

I have started hormone therapy for prostate cancer less than 2 months ago.

I agree to use contraception during and up to 120 days after the study.

I am 18 years old or older.

I am fully active or restricted in physically strenuous activity but can do light work.

My prostate cancer was confirmed through a tissue examination.

Exclusion Criteria

I have had surgery to remove my prostate.

I have had radiation therapy to my prostate before.

I am not a candidate for targeted radiation for prostate or limited metastases.

My cancer does not have neuroendocrine or small cell features.

My cancer has not spread to my liver.

I have an active TB infection.

I haven't had cancer treatment with a monoclonal antibody in the last 4 weeks or have recovered from its side effects.

I haven't had cancer treatment in the last 2 weeks or have recovered from its side effects.

I have received immunotherapy or chemotherapy for prostate cancer.

Treatment Details

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.

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.