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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

41

Participants

Timeline

Start Date

June 7, 2021

Primary Completion Date

February 28, 2026

Study Completion Date

August 31, 2028

Conditions
Metastatic Prostate Neuroendocrine CarcinomaMetastatic Prostate Cancer
Interventions
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."

Trial Locations (3)

10022

Weill Cornell Medicine, New York

27710

Duke University Medical Center, Durham

77030

MD Anderson Cancer Center, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

Andrew J. Armstrong, MD

OTHER

NCT04709276 - A Study of Chemoimmunotherapy for the Treatment of Men With Neuroendocrine or Aggressive Variant Metastatic Prostate Cancer | Biotech Hunter | Biotech Hunter