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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03477864
Other study ID # 17G.508
Secondary ID
Status Withdrawn
Phase Phase 1
First received
Last updated
Start date December 24, 2018
Est. completion date November 4, 2019

Study information

Verified date November 2019
Source Thomas Jefferson University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase I trial studies the side effects of anti-PD-1 monoclonal antibody REGN2810 (REGN2810) and/or ipilimumab when given together with stereotactic body radiation therapy before surgery in treating participants with prostate cancer that is growing, spreading, or getting worse, and has spread to other places in the body, or formed a small number of new tumors in one or two other parts of the body. Monoclonal antibodies, such as anti-PD-1 monoclonal antibody REGN2810 and ipilimumab, may interfere with the ability of tumor cells to grow and spread. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. Giving anti-PD-1 monoclonal antibody REGN2810 and ipilimumab with stereotactic body radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.


Description:

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Study Design


Intervention

Biological:
Ipilimumab
Given via intraprostatic injection
Radiation:
Stereotactic Body Radiation Therapy (SBRT)
Undergo SBRT
Procedure:
Radical Prostatectomy
Undergo radical prostatectomy
Biological:
Anti-PD-1 Monoclonal Antibody REGN2810
Given IV

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Sidney Kimmel Cancer Center at Thomas Jefferson University Prostate Cancer Foundation, Regeneron Pharmaceuticals

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of adverse events as defined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 criteria Will be assessed by quantifying the toxicities and grades 3 and 4 experienced by subjects who have received REGN2810 + ipilimumab in combination with radiation therapy, including serious adverse events (SAEs) and events of clinical interest (ECIs). Time-to-event continual reassessment (TITE-CRM) design will be used to confirm the safety of the treatments based on toxicities. Up to 70 days
Secondary Overall pathologic response rate Will be presented with appropriate confidence intervals (95%, unless otherwise specified). Up to 2 years
Secondary Prostate specific antigen (PSA) progression free survival Will be estimated using the Kaplan-Meier method. Up to 2 years
Secondary Radiographic progression free survival Will be estimated using the Kaplan-Meier method. Up to 2 years
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