NCT04709276

A Study of Chemoimmunotherapy for the Treatment of Men With Neuroendocrine or Aggressive Variant Metastatic Prostate Cancer

A Phase II, Single Arm Study of Chemoimmunotherapy for the Treatment of Men With Neuroendocrine or Aggressive Variant Metastatic Prostate Cancer (CHAMP)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Andrew J. Armstrong, MD · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of a combination of nivolumab, ipilimumab, cabazitaxel and carboplatin in men with neuroendocrine prostate cancer (NEPC) or other aggressive variants of prostate cancer (AVPC). This study will also investigate biomarkers to gain a better understanding of how the drug combination of nivolumab, ipilimumab, cabazitaxel and carboplatin affects these types of prostate cancer and the immune system. Eligible subjects will receive up to 10 cycles of nivolumab, ipilimumab, carboplatin and cabazitaxel followed by maintenance nivolumab and ipilimumab. Subjects may continue receiving study drugs until cancer progression, severe toxicity, withdrawal of consent, 3 years from the initial dose of study drugs or study termination, whichever occurs earlier. Subjects will be followed for 3 years from the initial dose of study drugs.

Conditions

• Metastatic Prostate Neuroendocrine Carcinoma
• Metastatic Prostate Cancer

Interventions

Type	Name	Description
DRUG	Nivolumab	360 mg intravenously every 3 weeks
DRUG	Ipilimumab	1 mg/kg intravenously every 6 weeks
DRUG	Carboplatin	AUC 4 mg/ml per minute intravenously every 3 weeks for up to 10 cycles. Subjects will also receive granulocyte-colony stimulating factor (G-CSF) therapy while receiving carboplatin.
DRUG	Cabazitaxel	20 or 25 mg/m2 intravenously every 3 weeks for up to 10 cycles. Subjects will also take prednisone by mouth at a dose of 10 mg daily and receive granulocyte-colony stimulating factor (G-CSF) therapy while receiving cabazitaxel.

Timeline

• Start date: 2021-06-07
• Primary completion: 2026-02-26
• Completion: 2028-08-01
• First posted: 2021-01-14
• Last updated: 2026-04-06

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study