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Checkpoint Inhibitor

Ipilimumab + Abiraterone Acetate + Prednisone for Prostate Cancer

Q: What maladies are typically treated with Ipilimumab?

<p>Ipilimumab is capable of treating cutaneous <a href="https://www.withpower.com/clinical-trials/melanoma">melanoma</a>, cases where a complete resection has been achieved, and liver carcinomas.</p>

Phase 1 & 2

Waitlist Available

Led By Daniel C. Danila, 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

Age 18 or older, and willing and able to provide informed consent

Chemotherapy- and immunotherapy-naïve patients with progressive metastatic CRPC are eligible

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is testing ipilimumab in combination with abiraterone acetate and prednisone to see if it is effective in treating prostate cancer.

Who is the study for?

Men aged 18+ with advanced prostate cancer that has spread beyond the pelvic region and is resistant to hormone therapy. They must be chemotherapy and immunotherapy-naïve, have a life expectancy of at least 6 months, and a good performance status. Excluded are those with other cancers in the last 5 years, certain blood or liver conditions, recent major surgery or radiation, autoimmune diseases, brain metastasis, active infections contraindicating prednisone use, significant heart disease or uncontrolled high blood pressure.Check my eligibility

What is being tested?

The trial investigates the combination of Ipilimumab (an immune system booster) with Abiraterone Acetate plus Prednisone (hormonal drugs lowering testosterone which feeds prostate cancer growth). This study aims to determine how well these medications work together for patients who haven't had chemo or immunotherapy before.See study design

What are the potential side effects?

Possible side effects include immune-related reactions affecting organs like intestines or liver; skin issues; hormonal imbalances due to lowered testosterone; fatigue; digestive problems such as nausea and diarrhea; increased risk of infections due to suppressed immune function.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 or older and can give my consent.

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I have metastatic CRPC and haven't received chemotherapy or immunotherapy.

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I am currently on hormone therapy for cancer.

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My cancer has spread beyond the pelvic region, confirmed by scans.

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My prostate cancer is getting worse according to my PSA levels or scans.

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I am mostly independent and doctors expect me to live 6 months or more.

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My prostate cancer diagnosis was confirmed through tissue examination.

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

progression-free survival (PFS) Phase II

safety (Phase I)

Secondary outcome measures

Changes in PSA kinetics

Evaluate changes in radionuclide bone scan

Measurable disease when present

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

1Treatment groups

Experimental Treatment

Group I: ipilimumabExperimental Treatment1 Intervention

This multi-institution open label study has a Phase 1 and Phase 2 component. The Phase 1 dose escalation stage is to establish the tolerability of ipilimumab to be used in combination with the standard clinical dose of abiraterone acetate plus prednisone in chemotherapy and immunotherapy-naïve patients with progressive metastatic CRPC. Due to the overlapping potential hepatic toxicity between abiraterone and ipilimumab, a Lead in Therapy with abiraterone plus prednisone for 2 cycles will assess for adverse events related to the abiraterone plus prednisone. Patients, who tolerate well the Lead in therapy as defined by Grade 1 or less AEs, will pursue Combination Therapy. Patients with AEs Grade ≥ 2 after Lead in Therapy will be excluded and replaced. The Phase 2 stage will assess efficacy and confirm an acceptable safety profile of the recommended dose.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ipilimumab

FDA approved

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,937 Previous Clinical Trials

588,263 Total Patients Enrolled

132 Trials studying Prostate Cancer

51,455 Patients Enrolled for Prostate Cancer

Bristol-Myers SquibbIndustry Sponsor

2,645 Previous Clinical Trials

4,130,942 Total Patients Enrolled

42 Trials studying Prostate Cancer

5,400 Patients Enrolled for Prostate Cancer

Northwestern UniversityOTHER

1,592 Previous Clinical Trials

917,985 Total Patients Enrolled

19 Trials studying Prostate Cancer

2,902 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

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

What is the current participant count for this research endeavor?

"Unfortunately, this medical trial is not currently enrolling participants. It was initially published on September 1st 2012 and last amended on the 9th of September 2022. However, there are 1321 studies that accept prostate cancer patients and 318 trials with Ipilimumab as an active ingredient actively taking in new members at present."

Answered by AI

What maladies are typically treated with Ipilimumab?

"Ipilimumab is capable of treating cutaneous melanoma, cases where a complete resection has been achieved, and liver carcinomas."

Answered by AI

Are there any preceding trials that have studied the efficacy of Ipilimumab?

"Ipilimumab entered clinical trials in 2009 at Texas Children's Hospital and has since seen 187 studies completed. At present, 318 active trails are recruiting participants; Evanston, Illinois is a major hub for these types of trial initiatives."

Answered by AI

Is enrollment still open for this trial?

"Unfortunately, this clinical trial has already ceased recruitment. Originally posted on September 1st 2012 and last updated on the 9th of September 2022, it is no longer available for participation. However, there are still 1321 studies seeking patients with prostate cancer and 318 trials utilizing Ipilimumab that are currently recruiting individuals."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Combining Ipilimumab With Abiraterone Acetate Plus Prednisone in Chemotherapy and Immunotherapy-naïve Patients With Progressive Metastatic Castration-resistant Prostate Cancer

2012. "Combining Ipilimumab With Abiraterone Acetate Plus Prednisone in Chemotherapy and Immunotherapy-naïve Patients With Progressive Metastatic Castration-resistant Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01688492.