Ipilimumab + Abiraterone Acetate + Prednisone for Prostate Cancer

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byDaniel Danila, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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 Criteria

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.

Inclusion Criteria

I am 18 or older and can give my consent.

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

I am currently on hormone therapy for cancer.

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Exclusion Criteria

I have had major surgery or radiation therapy recently.

I have not taken antiandrogen medication in the last 4 weeks.

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

See 11 more

Treatment Details

Interventions

Ipilimumab (Checkpoint Inhibitor)

Trial OverviewThe 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.

Participant Groups

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.

Ipilimumab is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Yervoy for: