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

ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

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

A Phase 2 Study Combining Ipilimumab With Abiraterone Acetate Plus Prednisone in Chemotherapy and Immunotherapy-naïve Patients With Progressive Metastatic Castration-resistant Prostate Cancer

NCT01688492•Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

Summary

The purpose of this study is to find out what effects, good and/or bad, taking ipilimumab with abiraterone acetate plus prednisone has on the patient and the prostate cancer. Abiraterone acetate plus prednisone are drugs that lower testosterone (testosterone stimulates prostate cancer growth). Abiraterone acetate plus prednisone is a treatment for patients with prostate cancer. Abiraterone acetate plus prednisone has not been used together with ipilimumab before. This study will test how they work together. Each patient will receive abiraterone acetate, prednisone and ipilimumab.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Chemotherapy- and immunotherapy-naïve patients with progressive metastatic CRPC are eligible.
•Age 18 or older, and be willing and able to provide informed consent.
•Histologically or cytologically confirmed adenocarcinoma of the prostate at either MSKCC or at the participating site.
•Castrate serum testosterone level, ≤ 1.73 nmol/L (50 ng/dL), at the Screening visit.
•Ongoing androgen deprivation therapy with a GnRH analogue or bilateral orchiectomy (ie, surgical or medical castration).

Exclusion Criteria

•Progressive disease at study entry defined by PSA and/or radiographic criteria according to the PCWG2.
•Karnofsky performance status of ≥80-100, and estimated life expectancy of ≥ 6 months.
•Toxicities related to prior therapy must either have returned to ≤ Grade 1 or baseline or been deemed irreversible and in the opinion of the Investigator not worsened.
•Able to swallow the study drug and comply with study requirements.
•History of another malignancy within the previous 5 years other than nonmelanomatous skin cancer.
•Absolute neutrophil count \< 1,500/μL, or platelet count \< 75,000/μL, or hemoglobin \< 5.6 mmol/L (9 g/dL) at the Screening visit. (NOTE: patients may not have received any growth factors within 7 days or blood transfusions within 28 days of the hematologic laboratory values obtained at the Screening visit).
•Serum bilirubin ≥ 1.5 x ULN or for patients with Gilbert's disease, ≥3 mg/dL at the Screening visit; AST or ALT ≥ 2.5 x ULN, (for patients with known liver metastasis, AST or ALT ≤ 5 x ULN is allowed) at the Screening visit.
•Creatinine \> 177 μmol/L (2 mg/dL), albumin \< 30 g/L (3.0 g/dL), potassium ≤ 3.5 mEq/L at the Screening visit.
•Clinically significant cardiovascular disease including myocardial infarction within 6 months, uncontrolled angina within 3 months, congestive heart failure New York Heart Association (NYHA) class 3 or 4, uncontrolled hypertension as indicated by systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 95 mmHg at the Screening visit.
•Major surgery or radiation therapy within 4 weeks of enrollment (Day 1 Visit).
+8 more criteria

Locations (3)

Northwestern University

Evanston, Illinois, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Oregon Health & Science University

Portland, Oregon, United States

Key Dates

Start Date

September 1, 2012

Primary Completion Date

September 1, 2026

Completion Date

September 1, 2026

Last Updated

August 12, 2025

Enrollment

ESTIMATED participants

Conditions

Prostate Cancer

Interventions

Ipilimumab

DRUG

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RECRUITINGPHASE2

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

NCT06842498

Metastatic Castration-Resistant Prostate Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 12, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

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Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC