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Pembrolizumab · 1 trial · 1 indication
Only participants in cohort 2, who achieve testosterone recovery to non-castrate levels (\>150 ng/dL) at 15 months, will be analyzed for the primary endpoint. The rate of PSA \< nadir + 2 ng/mL at 15 months from the start of radiotherapy and cycle 1, day 1 of pembrolizumab, among participants whose testosterone recovers to non-castrate levels (\>150 ng/dL). The point estimate of the rate of PSA \< nadir + 2 ng/mL will be obtained with its 95% confidence interval for participants by arm in cohort 2. All participants who receive any part of a dose of RT, SD-101 or pembrolizumab will be analyzed for efficacy.
Adverse events occurring on study will be summarized for all participants that received study intervention (including pembrolizumab, SD-101, SBRT to prostate, SBRT to oligometastatic sites) by maximum toxicity grade across study arms.
| Arm | Type | Description |
|---|---|---|
| Cohort 1, Arm 1: Prostate Only Sites (ADT, SBRT, Pembrolizumab) | EXPERIMENTAL | 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. |
| Cohort 1, Arm 2: Prostate Only Sites (ADT, SBRT, Pembrolizumab, SD-101) | EXPERIMENTAL | 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. |
| Cohort 2, Arm 1: Prostate and Oligometastatic sites (ADT, SBRT, Pembrolizumab) | EXPERIMENTAL | 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. |
| Cohort 2, Arm 2: Prostate and Oligometastatic sites (ADT, SBRT, Pembrolizumab, SD-101) | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| Pembrolizumab | DRUG | 200 mg IV every 21 days for up to 13 doses (Arms 1 and 2) |
| SD-101 | DRUG | 5 mg will be delivered to the dominant prostatic tumor lesion at time of fiducial marker placement (1-5 weeks prior to Cycle 1, Day 1) and and 1-3 weeks after Cycle 1 Day 1 |
| Leuprolide acetate | DRUG | 22.5 mg will be given intramuscularly (IM). First injection 3 months prior to Cycle 1 Day 1. Intermittent androgen deprivation therapy will be given every 3 months starting Cycle 1, Day 1 for 3 additional doses. |
| Abiraterone Acetate | DRUG | 1000 mg oral dosage will be given daily for 3 months prior to Cycle 1, Day 1 and daily for 9 months starting Cycle 1, Day 1. |
| Prednisone | DRUG | 5 mg oral dosage will be given daily for 3 months prior to Cycle 1 Day 1 and daily for 9 months starting Cycle 1, Day 1. |
| Stereotactic Body Radiation Therapy | RADIATION | 7 Gy x 5 fractions (35 Gy total) 1-2 weeks after fiducial marker placement and simulation over 10-14 days. |
Inclusion Criteria: 1. Be willing and able to provide written informed consent/assent for the trial. 2. Be \>=18 years of age on day of signing informed consent. 3. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale. 4. Histologically documented a...
Pembrolizumab is being studied for the treatment of prostatic neoplasms, specifically in hormone-naïve oligometastatic prostate cancer. It is being evaluated in combination with SD-101, radiation therapy, and intensified androgen deprivation therapy. The drug is currently in Phase 2 clinical development for this indication.
Pembrolizumab is being developed by TriSalus Life Sciences, Inc., a company traded under the ticker symbol TLSI. The company is conducting clinical research on this drug for the treatment of prostate cancer.
Pembrolizumab is in Phase 2 clinical development for the treatment of prostatic neoplasms. It is an investigational drug and has not been approved by regulatory authorities for this indication. A Phase 2 clinical trial has been completed to evaluate its safety and efficacy.
Pembrolizumab has been studied in a Phase 2 clinical trial with the identifier NCT03007732. This trial evaluated pembrolizumab with or without SD-101 in hormone-naïve oligometastatic prostate cancer patients receiving radiation therapy and intensified androgen deprivation therapy. The trial was completed in the United States with 23 participants.
No, Pembrolizumab is not the same as SD-101. Pembrolizumab is the investigational drug being studied, while SD-101 is a separate agent used in combination with pembrolizumab in the clinical trial. The trial evaluated pembrolizumab with or without SD-101 in prostate cancer patients.
Pembrolizumab is a small molecule drug being studied for prostate cancer. Its specific molecular target has not been disclosed in the available information. The drug is being evaluated in a biomarker-selected patient population, indicating that certain biomarkers may be relevant to its mechanism of action.