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

University Hospital, Ghent1 site in 1 country20 target enrollmentSeptember 1, 2016

ConditionsMelanoma

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Melanoma
Sponsor: University Hospital, Ghent
Enrollment: 20
Locations: 1
Primary Endpoint: Efficacy
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

September 1, 2016

End Date

December 31, 2019

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University Hospital, Ghent

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.
•Histologically confirmed diagnosis of melanoma
•At least 3 extracranial measurable metastatic lesions per RECIST v1.
•All radiology studies must be performed within 28 days prior to registration
•First line anti-PD1 treatment.
•Karnofsky Performance status \> 60
•Age 18 years or older
•Female participants of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study treatment
•Female participants who are breastfeeding or plan to breastfeed should be instructed to discontinue nursing during treatment.
•Male participants must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study treatment

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

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.