MedTrace Logo

Combining Ipilimumab, Degarelix, and Radical Prostatectomy in Men With Newly Diagnosed Metastatic Castration Sensitive Prostate Cancer or Ipilimumab and Degarelix in Men With Biochemically Recurrent Castration Sensitive Prostate Cancer After Radical Prostatectomy

NCT02020070 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-08-19

No results posted yet for this study

Summary

The purpose of this study is to find out what effects, good and/or bad, taking ipilimumab with degarelix before surgery to remove the prostate, followed by more degarelix and ipilimumab after the surgery, will have on prostate cancer.

The goal of this trial is to assess the safety and efficacy of a multimodality approach combining hormones and immunotherapy in prostate cancer populations that are considered incurable and standardly treated with hormones alone, and represent clinical states prior to development of castration-resistant disease. There are 2 cohorts. The first will use ipilimumab and degarelix prior to and following radical prostatectomy in men with newly diagnosed, oligometastatic, castration-sensitive disease. The second cohort will include men who have already received definitive local therapy with radical prostatectomy but have since experienced biochemical and/or metastatic recurrence.

Conditions

  • Metastatic Castration Sensitive Prostate Cancer

Interventions

DRUG

Degarelix

DRUG

Ipilimumab

PROCEDURE

Radical Prostatectomy

Sponsors & Collaborators

Principal Investigators

  • Karen Autio, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-18
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT02020070 on ClinicalTrials.gov