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 | Active Not Recruiting Phase 2

• 1 other identifier: 13-134
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Ipilimumab; Degarelix; Radical Prostatectomy; 13-134

Outcome Measures

Primary Outcomes (1)

• undetectable PSA

  An undetectable PSA at 12 and 20 months (weeks 52 and 84, respectively) from the start of treatment among patients with non-castrate (\> 150 ng/ml) levels of testosterone. An undetectable PSA is defined as PSA ≤0.05 ng/mL.

  at 12 and 20 months

Secondary Outcomes (3)

• progression-free survival (PFS)

  2 years

• overall survival (OS)

  2 years

• Toxicity

  2 years

Study Arms (2)

Ipilimumab & Degarelix With Radical Prostatectomy

EXPERIMENTAL

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.

Drug: Degarelix; Drug: Ipilimumab; Procedure: Radical Prostatectomy

Ipilimumab & Degarelix With Prior With Radical Prostatectomy

EXPERIMENTAL

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).

Drug: Degarelix; Drug: Ipilimumab

Interventions

Degarelix DRUG

Ipilimumab & Degarelix With Prior With Radical Prostatectomy; Ipilimumab & Degarelix With Radical Prostatectomy

Ipilimumab DRUG

Ipilimumab & Degarelix With Prior With Radical Prostatectomy; Ipilimumab & Degarelix With Radical Prostatectomy

Radical Prostatectomy PROCEDURE

Ipilimumab & Degarelix With Radical Prostatectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Target Population: Cohort A Patients with castration-sensitive oligometastatic prostate cancer who have not received primary local therapy (radiation or surgery), and no more than 5 months of prior androgen deprivation therapy.
• The subject must be age 18 or older, and be willing and able to provide informed consent.
• The subject must have histologically confirmed adenocarcinoma of the prostate with tissue confirmation at selected study site.
• The subject must have newly diagnosed prostate cancer with a metastatic site(s).
• The subject must have a history or presence of ≤ 10 bony metastatic lesions
• Note: bone mets that are not clearly identified on bone imaging, but are biopsy proven are allowed
• History or presence of distant metastatic lymph node(s) (e.g., retroperitoneal or non-regional pelvic lymph nodes) are allowed
• History or presence of regional pelvic lymph nodes (as per AJCC Cancer Staging \[7th edition\]) will be considered a metastatic site if greater than 1.5cm in shortest dimension.
• The subject must have Karnofsky performance status of 80-100.
• Normal organ function with acceptable initial laboratory values:
• WBC ≥ 2000/μL
• ANC ≥ 1000/ μL
• Platelets ≥ 75 x 103/μL
• Creatinine ≤ 2.0 x ULN
• AST/ALT ≤ 2.5 x ULN

You may not qualify if:

• Patients that meet any of the criteria listed below will not be eligible for Cohort A entry:
• Any other malignancy from which the patient has been disease-free for less than 5 years, with the exception of adequately treated and cured basal or squamous cell skin cancer or superficial bladder cancer
• Major surgery within 4 weeks of enrollment (Week 1 Visit).
• Current or prior radiation therapy to the prostate Prior radiation to a metastatic site (e.g., palliative radiation) is allowed..
• More than 5 months of prior hormonal therapy (e.g., gonadotropin hormone releasing analogs, megestrol acetate, or casodex) . There is no washout period required for GnRH analogs. A two week washout is required for megestrol or anti-androgen.
• Prior use of an 5 alpha reductase inhibitor is allowed (no limit on duration of use), however a two week washout is required.
• Prior ketoconazole, abiraterone acetate, or enzalutamide for the treatment of prostate cancer.
• Current or prior investigational therapies for prostate cancer, or chemotherapy administered with the intent to treat prostate cancer.
• Concomitant therapy with any other experimental drug.
• Autoimmune disease: Patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's Disease, are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis \[scleroderma\], systemic lupus erythematosus, autoimmune vasculitis \[e.g., Wegener's granulomatosis\]); motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis).
• Any underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of ipilimumab hazardous or obscure the interpretation of AEs, such as a condition associated with frequent diarrhea.
• Patients with underlying heart conditions who are deemed ineligible for surgery.
• Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab).
• Note: Inactivated vaccines are allowed at any time on study.
• A history of prior treatment with ipilimumab or prior CD137 agonist or CTLA-4 inhibitor or agonist.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Ferring Pharmaceuticals: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Interventions

acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide; Ipilimumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Karen Autio, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2013
• First Posted: December 24, 2013
• Study Start: December 18, 2013
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 19, 2025

Record last verified: 2025-08

Locations

US (1)