Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-28 @ 7:51 PM
Study NCT ID:
NCT02489357
Status:
COMPLETED
Last Update Posted:
2021-11-12
First Post:
2015-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pembrolizumab and Cryosurgery in Treating Patients With Newly Diagnosed, Oligo-metastatic Prostate Cancer
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Study Overview
Official Title:
A Pilot Study of MK-3475 With Cryotherapy for Men With Newly Diagnosed Oligo-metastatic Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This pilot phase II trial studies the side effects and how well pembrolizumab and cryosurgery work with short term androgen ablation to treat patients with prostate cancer that has traveled from the original tumor, through the body, and formed a small number of new tumors in other parts of the body (oligo-metastatic). Cryosurgery, also known as cryoablation or cryotherapy, kills tumor cells by freezing them. The process also incites an immune response within the ablated tumor. Giving monoclonal antibodies such as pembrolizumab which enhance a systemic anti-cancer immune response, may augment the effects of cryosurgery and increase tumor killing at distant (metastatic) sites.
Detailed Description:
PRIMARY OBJECTIVES:
I. Assess feasibility via the proportion of men reaching a low prostate-specific antigen (PSA) nadir (\< 0.6 ng/ml) at 1 year.
II. Evaluate the safety of cryotherapy to the prostate combined with pembrolizumab.
TERTIARY OBJECTIVES:
I. To evaluate the effects of combination cryotherapy / pembrolizumab on programmed cell death 1 (PD-1) and programmed cell death 1 ligand 1 (PD-L1) expression in the prostate as assessed by biopsy performed 6 months post treatment.
OUTLINE:
Patients receive standard of care androgen ablation with degarelix subcutaneously (SC) once a month for 8 months. Within 1 month of receiving degarelix, patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Within 3 days of receiving the first dose of pembrolizumab, patients undergo whole gland cryoablation of the prostate.
After completion of study treatment, patients are followed up at 30 days and then every 12 weeks for up to 1 year.
I. Assess feasibility via the proportion of men reaching a low prostate-specific antigen (PSA) nadir (\< 0.6 ng/ml) at 1 year.
II. Evaluate the safety of cryotherapy to the prostate combined with pembrolizumab.
TERTIARY OBJECTIVES:
I. To evaluate the effects of combination cryotherapy / pembrolizumab on programmed cell death 1 (PD-1) and programmed cell death 1 ligand 1 (PD-L1) expression in the prostate as assessed by biopsy performed 6 months post treatment.
OUTLINE:
Patients receive standard of care androgen ablation with degarelix subcutaneously (SC) once a month for 8 months. Within 1 month of receiving degarelix, patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Within 3 days of receiving the first dose of pembrolizumab, patients undergo whole gland cryoablation of the prostate.
After completion of study treatment, patients are followed up at 30 days and then every 12 weeks for up to 1 year.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2015-00981 | OTHER | CTRP (Clinical Trial Reporting Program) | View | |
| IRB00045444 | None | None | View | |
| MK-3475 | None | None | View | |
| P30CA006973 | NIH | None | https://reporter.nih.gov/quic… | View |