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Checkpoint Inhibitor

Ipilimumab + Abiraterone Acetate + Prednisone for Prostate Cancer

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

Must not have

Recent major surgery or radiation therapy

Uncontrolled or significant medical condition other than cancer that would prevent participation in the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

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

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I have had major surgery or radiation therapy recently.

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I don't have any major health issues besides cancer that would stop me from joining the study.

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I have a serious heart condition.

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I do not have any infections or conditions that prevent me from taking prednisone.

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My liver or kidney tests were not normal at my last check-up.

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I have not had any cancer other than non-dangerous skin cancer in the last 5 years.

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I have brain metastasis or untreated leptomeningeal disease.

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I have active hepatitis or chronic liver disease.

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My prostate cancer got worse while I was on ketoconazole.

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

progression-free survival (PFS) Phase II

safety (Phase I)

Secondary study objectives

Changes in PSA kinetics

Evaluate changes in radionuclide bone scan

Measurable disease when present

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.

No Placebo-Only Group

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

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 / 16Eligibility criteria met