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Hormone Therapy

Ipilimumab + Degarelix for Prostate Cancer

Phase 2

Waitlist Available

Led By Karen Autio, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Karnofsky performance status of 80-100

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

Must not have

Prior use of certain medications for prostate cancer

Patients with underlying heart conditions ineligible for surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

Summary

This trial is designed to study the safety and efficacy of a multimodality approach combining hormones and immunotherapy in prostate cancer populations.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Ipilimumab can cause immune-related side effects like inflammation in various organs, skin rash, diarrhea, hormonal deficiencies, and fatigue. Degarelix may lead to hot flashes, injection site reactions, weight gain, increased liver enzymes, and changes in blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am mostly self-sufficient and active.

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I have prostate cancer that has spread but responds to hormone therapy, and I haven't had surgery or radiation yet.

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I have large pelvic lymph nodes, over 1.5cm.

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My prostate cancer diagnosis was confirmed with a tissue test.

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I have recently been diagnosed with prostate cancer that has spread.

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I have 10 or fewer bone metastases.

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My cancer has spread to distant lymph nodes.

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My organ functions are normal based on recent tests.

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I am 18 or older and can give my consent.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have taken specific medications for prostate cancer before.

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

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I have received immunotherapy treatments.

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I have been treated with specific drugs in the past.

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I have a medical condition that increases my risk of bowel tears.

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I have a history of disorders related to lymphocyte proliferation.

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I have a history of cancer.

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I have not had major surgery in the last 4 weeks.

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I have received radiation therapy for prostate cancer.

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I have been on hormonal therapy for over 5 months.

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I have received experimental treatments or chemotherapy for prostate cancer.

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I do not have health or mental conditions that affect taking ipilimumab.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

undetectable PSA

Secondary study objectives

Toxicity

overall survival (OS)

progression-free survival (PFS)

Side effects data

From 2024 Phase 3 trial • 529 Patients • NCT02017717

80%

Fatigue

70%

Diarrhoea

70%

Headache

40%

Vomiting

40%

Aspartate aminotransferase increased

40%

Rash maculo-papular

40%

Alanine aminotransferase increased

40%

Lipase increased

30%

Partial seizures

30%

Hemiparesis

30%

Gait disturbance

30%

Fall

30%

Cough

30%

Dry skin

30%

Amylase increased

30%

Nausea

30%

Confusional state

20%

Malignant neoplasm progression

20%

Pyrexia

20%

Candida infection

20%

Mucosal infection

20%

Decreased appetite

20%

Back pain

20%

Dysphonia

20%

Hypotension

20%

Colitis

20%

Hyperthyroidism

20%

Oedema peripheral

20%

Muscular weakness

20%

Hypothyroidism

10%

Tinnitus

10%

Cushingoid

10%

Diabetic ketoacidosis

10%

Procedural haemorrhage

10%

Blood bilirubin increased

10%

Bradycardia

10%

Sinus tachycardia

10%

Hyperglycaemia

10%

Hypocalcaemia

10%

Neck pain

10%

Brain oedema

10%

Hydrocephalus

10%

Lethargy

10%

Seizure

10%

Hypertension

10%

Palpitations

10%

Cheilitis

10%

Presyncope

10%

Face oedema

10%

Oedema

10%

Conjunctivitis

10%

Enterocolitis infectious

10%

Oral candidiasis

10%

Pneumonia

10%

Sinusitis

10%

Staphylococcal infection

10%

Blood alkaline phosphatase increased

10%

Spinal pain

10%

Tremor

10%

Dizziness

10%

Dysarthria

10%

Urinary retention

10%

Dyspnoea exertional

10%

Nasal congestion

10%

Pneumonitis

10%

Dermatitis

10%

Erythema

10%

Rash

10%

Klebsiella infection

10%

Hypomagnesaemia

10%

Syncope

10%

Haemorrhage intracranial

10%

Pancreatitis

10%

Cholecystitis

10%

Upper respiratory tract infection

10%

Acute kidney injury

10%

Dermatitis bullous

10%

Lymphopenia

10%

Optic nerve disorder

10%

Visual impairment

10%

Dehydration

10%

Hypokalaemia

10%

Scoliosis

10%

Cognitive disorder

10%

Memory impairment

10%

Hallucination

10%

Insomnia

10%

Irritability

10%

Urinary incontinence

10%

Dyspnoea

10%

Dermatitis acneiform

10%

Pelvic venous thrombosis

10%

Sepsis

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 1: Arm N1+I3

Cohort 2: Arm B

Part A Cohort 1c: Arm N3+RT+TMZ

Part A Cohort 1d: Arm N3+RT

Part B Cohort 1c: Arm N3+RT+TMZ

Part B Cohort 1d: Arm N3+RT

Cohort 1: Arm N3

Cohort 1b: Arm N3+I1

Cohort 2: Arm N3

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Degarelix

FDA approved

Ipilimumab

FDA approved

Radical Prostatectomy

2005

Completed Phase 2

~4550