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

Part of paid clinical trials in New York, New York.

Sponsor
Andrew J. Armstrong, MD
Study ID
NCT04709276
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Metastatic Prostate Cancer
  • Metastatic Prostate Neuroendocrine Carcinoma

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    360 mg intravenously every 3 weeks
  • Ipilimumab — DRUG
    1 mg/kg intravenously every 6 weeks
  • Carboplatin — DRUG
    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.
  • Cabazitaxel — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jun 7, 2021
Status verified
Apr 2026
Primary completion
Feb 26, 2026
Completion
Aug 31, 2028

Study Design

Enrollment
41 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Neuroendocrine Prostate Cancer (NEPC) or Aggressive Variant Prostate Cancer (AVPC)
    Subjects with neuroendocrine prostate cancer (NEPC) or aggressive variant prostate cancer (AVPC) will receive a combination of nivolumab, ipilimumab, carboplatin and cabazitaxel for up to 10 cycles of 21 days each. After carboplatin and cabazitaxel are discontinued, a combination of nivolumab and ipilimumab will be administered. Nivolumab will be administered intravenously at a dose of 360 mg every 3 weeks. Ipilimumab will be administered intravenously at a dose of 1 mg/kg every 6 weeks. Carboplatin will be administered intravenously at a dose of AUC 4 mg/ml per minute. Cabazitaxel will be administered intravenously at a dose of 20 or 25 mg/m2.

Primary Outcome Measure

Proportion of subjects who are progression-free and alive (progression-free survival) at 6 months [ Time Frame: 6 months ]

Locations (3)

FacilityCityStateZIPSite coordinators
Weill Cornell MedicineNew YorkNew York10022-
Duke University Medical CenterDurhamNorth Carolina27710-
MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in New York, NY

By research site
Weill Cornell Medicine· New York, NYDuke University Medical Center· Durham, NCMD Anderson Cancer Center· Houston, TX

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