Ipilimumab + Degarelix for Prostate Cancer

Recruiting in Palo Alto (17 mi)

Overseen byKaren Autio, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for men over 18 with newly diagnosed metastatic prostate cancer who haven't had surgery or radiation yet, or those with a recurrence after surgery. They should have good physical function and no more than a few months of hormone therapy. Men must be willing to use contraception and not have other serious health issues or recent treatments that could interfere.

Inclusion Criteria

I am mostly self-sufficient and active.

I have large pelvic lymph nodes, over 1.5cm.

My prostate cancer diagnosis was confirmed with a tissue test.

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Exclusion Criteria

I have taken specific medications for prostate cancer before.

I have a heart condition that makes me ineligible for surgery.

I have received immunotherapy treatments.

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Treatment Details

Interventions

Degarelix (Hormone Therapy)
Ipilimumab (Checkpoint Inhibitor)
Radical Prostatectomy (Procedure)

Trial OverviewThe study tests the combination of ipilimumab (an immunotherapy drug) and degarelix (a hormone therapy) before and after surgical removal of the prostate in men with advanced prostate cancer. It aims to see if this approach is better than standard hormone treatment alone.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Ipilimumab & Degarelix With Radical ProstatectomyExperimental Treatment3 Interventions

Week 1: Degarelix SQ injection (except patients who have already received hormonal therapy per standard of care and are not yet due for their next dose) and Ipilimumab at 3 mg/kg intravenously (IV). Surgery Radical prostatectomy (RP)will be performed during week 3 ± 1 week or after recovery to grade ≤ 1 adverse events experienced during the induction period related to treatment. Continued Androgen Depletion and Ipilimumab Weeks 5, 9, 13, 17, 21, 25, and 29: Degarelix 80 mg SQ (except patients who have already received hormonal therapy per standard of care and are not yet due for their next dose) Week 11, 14, 17 or after sufficient wound healing and recovery post RP: Ipilimumab 3 mg/kg IV Follow-up Twelve week intervals until Week 87.

Group II: Ipilimumab & Degarelix With Prior With Radical ProstatectomyExperimental Treatment2 Interventions

Week 1: Degarelix 240 mg SQ injection and Ipilimumab at 3 mg/kg intravenously (IV) Continued Androgen Depletion and Ipilimumab Weeks 5, 9, 13, 17, 21, 25, and 29: Degarelix 80 mg SQ Week 4,7,10: Ipilimumab 3mg/kg IV Follow-up Twelve week intervals until Week 81, with MD visits at weeks 52 and 84 (12 and 20 months).

Degarelix is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Firmagon for: