NCT03477864

Stereotactic Body Radiation Therapy With REGN2810 and/or Ipilimumab Before Surgery in Treating Participants With Progressive Advanced or Oligometastatic Prostate Cancer

R2810-ONC-16XX: A Phase 1 Neoadjuvant Study of Stereotactic Body Radiation Therapy With Systemic REGN2810 and Intraprostatic Ipilimumab, Alone or in Combination, in Patients With Locally Advanced Prostate Cancer Prior to Radical Prostatectomy

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To determine the safety and tolerability for an established effective dose of systemic REGN2810 and intraprostatic ipilimumab with stereotactic body radiation therapy (SBRT) in patients with locally advanced prostate cancer with or without oligometastatic disease. SECONDARY OBJECTIVES: I. To determine overall pathologic response rate after radical prostatectomy. II. To determine prostate-specific antigen (PSA) progression free survival in men treated with REGN2810 and intraprostatic ipilimumab with SBRT. III. To determine radiographic progression free survival in men treated with REGN2810 and intraprostatic ipilimumab with SBRT. IV. Acute and chronic adverse events (AEs).

Conditions

• Stage III Prostate Cancer
• Stage IIIA Prostate Cancer
• Stage IIIB Prostate Cancer
• Stage IIIC Prostate Cancer
• Stage IV Prostate Cancer
• Stage IVA Prostate Cancer
• Stage IVB Prostate Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-12-24
• Primary completion: 2019-11-04
• Completion: 2019-11-04
• First posted: 2018-03-26
• Last updated: 2025-04-29

Regulatory

• FDA-regulated drug study