NCT02821182

A Phase II Trial of Stereotactic Body Radiotherapy With Concurrent Anti-PD1 Treatment in Metastatic Melanoma.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

We hypothesize that combining anti-PD1 treatment with radiotherapy might result in improved clinical response rates and PFS compared to anti-PD1 treatment in monotherapy. The current phase II trial aims at exploring the suggested benefits of the combination and aims to improve local and distant tumour responses by exploiting the pro-immunogenic effects of radiotherapy in addition to anti-PD1 treatment.

Conditions

• Melanoma

Interventions

Type	Name	Description
RADIATION	stereotactic body radiotherapy	In patients with metastatic melanoma, anti-PD-1 treatment will be combined with stereotactic body radiotherapy (SBRT). A total dose of 24 Gy SBRT will be delivered in 3 fractions to one measurable lesion and fractions will be separated \>48h and \<96h.

Timeline

• Start date: 2016-09-01
• Primary completion: 2018-09-09
• Completion: 2019-12-31
• First posted: 2016-07-01
• Last updated: 2022-12-29

Locations

1 site across 1 country: Belgium