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

  • STATUS
    Recruiting
  • End date
    Jun 21, 2027
  • participants needed
    43
  • sponsor
    Andrew J. Armstrong, MD
Updated on 21 June 2021

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.

Details
Condition Metastatic Prostate Cancer, Prostate Cancer Metastatic, Metastatic Prostate Neuroendocrine Carcinoma
Treatment carboplatin, Ipilimumab, Nivolumab, Cabazitaxel
Clinical Study IdentifierNCT04709276
SponsorAndrew J. Armstrong, MD
Last Modified on21 June 2021

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