Combining Ipilimumab With Abiraterone Acetate Plus Prednisone in Chemotherapy and Immunotherapy-n… (NCT01688492) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Combining Ipilimumab With Abiraterone Acetate Plus Prednisone in Chemotherapy and Immunotherapy-naïve Patients With Progressive Metastatic Castration-resistant Prostate Cancer
United States54 participantsStarted 2012-09
Plain-language 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.
Who can participate
Age range18 Years
SexMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
* Metastatic disease on imaging (e.g., bone scan, CT, MRI). Patients whose disease spread is limited to regional pelvic lymph nodes are not eligible. If lymph node metastasis is the only evidence of metastasis, it must be ≥ 2 cm in diameter.
* 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.
Exclusion Criteria:
* 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 fa…