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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

undetectable PSA

Secondary outcome measures

Toxicity

overall survival (OS)

progression-free survival (PFS)

Side effects data

From 2017 Phase 3 trial • 1289 Patients • NCT01285609

38%

Alopecia

36%

Anaemia

32%

Nausea

31%

Decreased appetite

31%

Diarrhoea

30%

Fatigue

25%

Constipation

23%

Neutropenia

20%

Dyspnoea

19%

Vomiting

19%

Pyrexia

18%

Rash

17%

Asthenia

17%

Cough

16%

Pruritus

16%

Thrombocytopenia

16%

Arthralgia

15%

Peripheral sensory neuropathy

14%

Myalgia

13%

Insomnia

13%

Neuropathy peripheral

11%

Hypokalaemia

10%

Platelet count decreased

Pain in extremity

Weight decreased

Leukopenia

Alanine aminotransferase increased

Hyponatraemia

Pneumonia

Haemoglobin decreased

Neutrophil count decreased

Dizziness

Malignant neoplasm progression

Aspartate aminotransferase increased

Bone pain

Haemoptysis

Back pain

Headache

Hypomagnesaemia

Stomatitis

Abdominal pain upper

Oedema peripheral

White blood cell count decreased

Chest pain

Dehydration

Abdominal pain

Febrile neutropenia

Paraesthesia

Musculoskeletal pain

Colitis

Death

Lung infection

Pulmonary embolism

Mucosal inflammation

Multi-organ failure

Cerebrovascular accident

Lung neoplasm malignant

Lung abscess

General physical health deterioration

Interstitial lung disease

Liver function test abnormal

Sudden death

Chronic obstructive pulmonary disease

Metastases to central nervous system

Blood creatinine increased

Atrial fibrillation

Cardio-respiratory arrest

Confusional state

Intestinal perforation

Pulmonary haemorrhage

Drug hypersensitivity

Infection

Pneumothorax

Renal failure

Lower respiratory tract infection

Pain

Respiratory failure

Syncope

Hyperglycaemia

Sepsis

Acute kidney injury

Hypersensitivity

Urinary tract infection

Disease progression

Pneumonitis

100%

80%

60%

40%

20%

Study treatment Arm

10 MG/KG Ipilimumab + Paclitaxel/ Carbop

Placebo + Paclitaxel/ Carboplatin

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

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,934 Previous Clinical Trials

588,794 Total Patients Enrolled

133 Trials studying Prostate Cancer

52,074 Patients Enrolled for Prostate Cancer

Ferring PharmaceuticalsIndustry Sponsor

313 Previous Clinical Trials

440,842 Total Patients Enrolled

52 Trials studying Prostate Cancer

17,867 Patients Enrolled for Prostate Cancer

Karen Autio, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

1 Previous Clinical Trials

44 Total Patients Enrolled

1 Trials studying Prostate Cancer

44 Patients Enrolled for Prostate Cancer

Media Library

Degarelix (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02020070 — Phase 2

Prostate Cancer Research Study Groups: Ipilimumab & Degarelix With Radical Prostatectomy, Ipilimumab & Degarelix With Prior With Radical Prostatectomy

Prostate Cancer Clinical Trial 2023: Degarelix Highlights & Side Effects. Trial Name: NCT02020070 — Phase 2

Degarelix (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02020070 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the anticipated participant count for this clinical trial?

"Currently, this medical trial is not enrolling new patients. It was first posted on the 18th of December 2013 and last modified on August 4th 2022. For those looking for other research studies, there are 1481 trials currently recruiting for malignant neoplasms and 348 clinicals researching Ipilimumab that need volunteers."

Answered by AI

What ailments has Ipilimumab been proven to treat?

"Ipilimumab is a common solution to progression after treatment with fluoropyrimidine, oxaliplatin and irinotecan. Additionally, ipilimumab has shown promise in treating regional lymph nodes > 1mm, colorectal carcinoma, and cutaneous melanoma."

Answered by AI

Has Ipilimumab been granted official sanction from the Food and Drug Administration?

"Our team at Power gave Ipilimumab a score of 2 since, as this is a Phase II trial, there has been some evidence that it can be safe but no proof yet of its efficacy."

Answered by AI

Are there still availabilities for participants in this research?

"According to clinicaltrials.gov, this particular medical study is not taking on any more participants; despite being originally posted in December of 2013 and updated as recently as August 4th 2022. However, 1829 other trials are still actively recruiting patients at the present moment."

Answered by AI

Has Ipilimumab been tested in prior experiments of this kind?

"Currently, there are 348 active clinical trials for Ipilimumab with 46 of them in the late-stage phase 3. While Pittsburgh is one of many locations running these studies, a total of 21842 sites have opted to investigate this drug around the world."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2013. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02020070.

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