Ipilimumab + Degarelix for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 61

16 Participants Needed

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.

Research Team

Karen Autio, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Treatment

Participants receive Degarelix and Ipilimumab before surgery

3 weeks

1 visit (in-person)

Surgery

Radical prostatectomy is performed

1 week

1 visit (in-person)

Post-Surgery Treatment

Continued Androgen Depletion and Ipilimumab administration

26 weeks

7 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

87 weeks

MD visits at weeks 52 and 84

Treatment Details

Interventions

• Degarelix
• Ipilimumab
• Radical Prostatectomy

Trial Overview The 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

Group I: Ipilimumab & Degarelix With Radical Prostatectomy Experimental Treatment 3 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 Prostatectomy Experimental Treatment 2 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:

• Advanced hormone-dependent prostate cancer

Approved in United States as Firmagon for:

• Advanced prostate cancer

Approved in Canada as Firmagon for:

• Hormone-sensitive prostate cancer

Approved in Japan as Firmagon for:

• Prostate cancer

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Ferring Pharmaceuticals

Industry Sponsor

Trials

323

Recruited

1,242,000+

Pierre-Yves Berclaz

Ferring Pharmaceuticals

Chief Medical Officer since 2023

MD from the University of Lausanne, PhD in Molecular Biology from the Cincinnati College of Medicine

Jean-Frédéric Paulsen

Ferring Pharmaceuticals

Chief Executive Officer since 2023

Master’s degree in Finance from the London School of Economics and Political Science