Ipilimumab + Degarelix for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must be taking: Hormonal therapy

Must not be taking: Chemotherapy, Immunotherapy, Corticosteroids

Disqualifiers: Autoimmune disease, Heart conditions, Others

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination of two drugs, ipilimumab (an immunotherapy drug) and degarelix (a hormone therapy drug), to evaluate their effectiveness in treating prostate cancer before and after prostate surgery. The study aims to understand the effects—both beneficial and adverse—of these medications in men whose prostate cancer has not yet become resistant to standard hormone treatments. Men with newly diagnosed prostate cancer that has spread to a few sites, or those whose cancer has returned after initial treatments, might be suitable candidates if they have specific conditions like a history of limited bone metastases (cancer spread to bones). As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial requires a two-week period without certain medications like megestrol, anti-androgens, and 5 alpha reductase inhibitors before starting. If you're on these, you'll need to stop them for two weeks before joining the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that combining ipilimumab with degarelix has been studied for treating prostate cancer. Ipilimumab, a type of immunotherapy, helps the immune system fight cancer, while degarelix, a hormone therapy, lowers testosterone, which prostate cancer cells need to grow.

Earlier studies found that ipilimumab can slow disease progression, though it may cause side effects like tiredness, diarrhea, and skin rash, with varying severity. Degarelix is generally well-tolerated but can cause hot flashes and injection site reactions. Researchers are investigating whether using these treatments together can be more effective than hormone therapy alone, aiming to determine if the combination can safely lead to better patient outcomes.

For those considering trial participation, knowing that this combination has been previously tested may provide reassurance about its safety. However, individual experiences can differ, so discussing potential risks and benefits with a healthcare professional is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about combining Ipilimumab and Degarelix for prostate cancer because this treatment approach has a unique mechanism of action. Ipilimumab is an immune checkpoint inhibitor that helps the immune system recognize and attack cancer cells more effectively, unlike traditional hormone therapies that mainly reduce androgen levels to slow cancer growth. By pairing Ipilimumab with Degarelix, a hormone therapy that suppresses testosterone production, this combination has the potential to enhance the body's immune response while also controlling hormone-sensitive tumor growth. This dual approach could offer a more comprehensive treatment strategy compared to conventional hormone therapy alone, potentially improving outcomes for patients with prostate cancer.

What evidence suggests that this trial's treatments could be effective for prostate cancer?

Research shows that combining ipilimumab with degarelix may effectively treat prostate cancer. In this trial, participants will receive both ipilimumab and degarelix, with some undergoing radical prostatectomy. Studies have found that this combination can sometimes lead to undetectable levels of PSA (prostate-specific antigen), indicating that the cancer might be under control. Ipilimumab helps the body's immune system attack cancer cells, while degarelix is a hormone therapy that reduces testosterone, which prostate cancer cells need to grow. Previous research has shown that ipilimumab can improve the time patients live without the cancer worsening. This suggests that combining these treatments might slow the disease and improve outcomes for patients with prostate cancer. ^{2 6 7 8 9}

Who Is on the Research Team?

Karen Autio, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT01377389

Ipilimumab + Androgen Depravation Therapy in Prostate ... This is an investigational study. Leuprolide, goserelin, and degarelix are FDA approved and commercially available for the treatment of prostate cancer.

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2017.35.6_suppl.203

A phase II study combining ipilimumab and degarelix with ... The primary endpoint was an undetectable PSA (<0.05) at 12 and 20 mos with non-castrate testosterone. Results: 16 pts (7 Coh A; 9 Coh B) were ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4847149/

Immune Checkpoint Therapies in Prostate Cancer - PMC In the first, the addition of ipilimumab improved progression-free survival (hazard ratio = 0·70 [95% 0·61–0·82]; p<0·0001 but failed to meet the primary ...

4. researchgate.net researchgate.net/publication/315967586_A_phase_II_study_combining_ipilimumab_and_degarelix_with_or_without_radical_prostatectomy_RP_in_men_with_newly_diagnosed_metastatic_noncastration_prostate_cancer_mNCPC_or_biochemically_recurrent_BR_NC

A phase II study combining ipilimumab and degarelix with ... Experimental data have demonstrated na increase in PSMA-expression in PCa metastases by androgen deprivation in vitro. The aim of the current ...

5. mdpi.com mdpi.com/2077-0383/12/4/1446

Immunotherapy for Prostate Cancer: A Current Systematic ... In this original research article, promising results were seen for ipilimumab intervention, with improved overall survival trends. A total of 68 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02020070?tab=table

Combining Ipilimumab, Degarelix, and Radical Prostatectomy in ... There are three types of violations: Failure to submit required clinical trial information; Submission of false or misleading clinical trial information ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0304383524005500

Advances in and prospects of immunotherapy for prostate ... Treatment outcomes were unsatisfactory. Monotherapy fails to overcome cold tumor characteristics and immune resistance mechanisms in prostate ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT01377389?term=AREA%5BNCTIdSearch%5D(NCT01377389)&rank=1

Ipilimumab + Androgen Depravation Therapy in Prostate ... Leuprolide, goserelin, and degarelix are designed to help stop the body from making testosterone (a male sex hormone that prostate cancer cells need to survive) ...

9. ctv.veeva.com ctv.veeva.com/study/ipilimumab-androgen-depravation-therapy-in-prostate-cancer

Ipilimumab + Androgen Depravation Therapy in Prostate Cancer Ipilimumab is designed to block the activity of cells that decrease the immune system's ability to fight cancer. Leuprolide, goserelin, and ...