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

NCT03477864 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2025-04-29

No results posted yet for this study

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.

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

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

Sponsors & Collaborators

  • Prostate Cancer Foundation

    collaborator OTHER

  • Regeneron Pharmaceuticals

    collaborator INDUSTRY

  • Sidney Kimmel Cancer Center at Thomas Jefferson University

    lead OTHER

Principal Investigators

  • Adam Dicker, MD · Sidney Kimmel Cancer Center at Thomas Jefferson University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-24
Primary Completion
2019-11-04
Completion
2019-11-04
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03477864 on ClinicalTrials.gov