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PD-L1 Inhibition as ChecKpoint Immunotherapy for NeuroEndocrine Phenotype Prostate Cancer

NCT03179410 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2021-03-05

Study results available
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Summary

The purpose of this study is to assess the safety and efficacy of avelumab in patients with metastatic neuroendocrine-like prostate cancer. Eligible men will be started on avelumab every 2 weeks and will stay on therapy until progression or intolerable side effects. The central hypothesis is that PD-L1 inhibition with avelumab will be efficacious based on radiographic responses in a subset of men with metastatic neuroendocrine-like prostate cancer and be reasonably well tolerated, meeting criteria for further study in larger phase 2 and 3 trials based on meeting pre-specified efficacy rates and prolonged PFS in some men.

Conditions

Interventions

DRUG

Avelumab

10 mg/kg intravenously every 2 weeks

Sponsors & Collaborators

  • Andrew J. Armstrong, MD

    lead OTHER

Principal Investigators

  • Andrew Armstrong, MD, ScM · Duke University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-01
Primary Completion
2020-01-09
Completion
2020-12-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03179410 on ClinicalTrials.gov