Trials / Completed
CompletedNCT02826564
Trial of Stereotactic Body Radiotherapy With Concurrent Pembrolizumab in Metastatic Urothelial Cancer
Phase I Trial of Stereotactic Body Radiotherapy With Concurrent Pembrolizumab in Metastatic Urothelial Cancer
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- University Hospital, Ghent · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The goal of the proposed research project is to assess the safety (dose limiting toxicity, DLT) of the combination of pembrolizumab and high-dose stereotactic body radiotherapy (SBRT) in patients with metastatic urothelial cancer. Both the SBRT dose and pembrolizumab dose will be fixed, but the timing of the combination will be varied. Secondary objectives include response rates, local control, progression-free survival (PFS) and overall survival (OS). Exploratory endpoints include immunologic responses and response rates in PD-L1- TIL- tumors. The combination sequence with the most promising response rates and the best safety profile will be selected to continue in a Phase II trial.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | pembrolizumab |
Timeline
- Start date
- 2016-11-14
- Primary completion
- 2018-04-02
- Completion
- 2019-02-18
- First posted
- 2016-07-11
- Last updated
- 2024-07-17
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT02826564. Inclusion in this directory is not an endorsement.