A Phase II Trial of Stereotactic Body Radiotherapy With Concurrent Anti-PD1 Treatment in Metastatic Melanoma.
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|ClinicalTrials.gov Identifier: NCT02821182|
Recruitment Status : Unknown
Verified April 2018 by Radiotherapie, University Hospital, Ghent.
Recruitment status was: Active, not recruiting
First Posted : July 1, 2016
Last Update Posted : May 1, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Radiation: stereotactic body radiotherapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Stereotactic Body Radiotherapy With Concurrent Anti-PD1 Treatment in Metastatic Melanoma.|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||December 2019|
Experimental: Anti-PD1 treatment in combination with SBRT
Patients receiving anti-PD1 treatment will be treated with high-dose radiotherapy to one lesion in 3 fractions prior to the second cycle of systemic therapy.
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.
- Efficacy [ Time Frame: 12 weeks ]Objective responses will be measured using RECIST v1.1. Objective responses will be defined as the number of patients with complete or partial responses as best response during follow-up.
- Immunologic responses [ Time Frame: 12 weeks ]
Immunologic responses will be assessed using peripheral blood samples, analyzed with FACS phenotyping, functional testing and ELISA.
Changes in immunological parameters in tissue will be analyzed using immunohistochemistry.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02821182
|University Hospital Ghent|
|Gent, West Vlaanderen, Belgium, 9000|