Trials / Completed
CompletedNCT03179410
PD-L1 Inhibition as ChecKpoint Immunotherapy for NeuroEndocrine Phenotype Prostate Cancer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- Andrew J. Armstrong, MD · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | Avelumab | 10 mg/kg intravenously every 2 weeks |
Timeline
- Start date
- 2018-02-01
- Primary completion
- 2020-01-09
- Completion
- 2020-12-18
- First posted
- 2017-06-07
- Last updated
- 2021-03-05
- Results posted
- 2021-03-05
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03179410. Inclusion in this directory is not an endorsement.