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PICK NEPC: Prostate Cancer - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn if it is safe and effective to give men with neuroendocrine prostate cancer avelumab.

What is the Condition Being Studied?

Neuroendocrine prostate cancer

Who Can Participate in the Study?

Adult males who have been diagnosed with neuroendocrine-like prostate cancer that have not been taking PD-1 inhibitors and/or 2 inhibitors, CTLA-4 inhibitors.

Age Group
Adults

What is Involved?

If you join the study, you will have a screening period that includes a physical exam, imaging scans, blood draws, and collection of archival tumor tissue.
After screening, you will:
- Come to the clinic to receive the study drug avelumab by IV infusion every 2 weeks.
- Have medical exams, answer questions about any medications or adverse events, have routine imaging scans, have blood drawn for routine tests and research tests, and complete quality of life questionnaires.
- Be asked for permission to have a tumor biopsy and donate some tissue to research when your cancer worsens.
- Come to the clinic 28 days after the last dose of avelumab and then be followed every 3 months for up to 3 years.

Study Details

Full Title
PD-L1 Inhibition as ChecKpoint Immunotherapy for NeuroEndocrine Phenotype Prostate Cancer (PICK NEPC)
Principal Investigator
Medical Oncologist
Protocol Number
IRB:PRO00080869
NCT:NCT03179410
Phase
Phase II
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698