APPLE
Research type
Research Study
Full title
Avelumab and hypofractionated palliative radiotherapy in metastatic soft-tissue sarcoma
IRAS ID
228888
Contact name
Shane Zaidi
Contact email
Sponsor organisation
Royal Marsden Hospital
Eudract number
2017-001316-11
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Soft-tissue sarcomas (STS) are a rare heterogeneous group of neoplasms arising from mesenchymal tissue. The median survival for patients with metastatic STS is between 12 and 18 months. Radiotherapy (RT) provides good local palliation in patients with metastatic STS. Although the majority of patients respond to RT, they frequently develop progressive disease at other sites. When managing patients with several metastases, it can sometimes be difficult to irradiate multiple sites concurrently without causing an unacceptable level of radiation-induced toxicity.
The recent success of immune checkpoint inhibitors in melanoma and other solid tumours has bought immunotherapy to the forefront of cancer therapy. Avelumab is a fully human IgG1 antibody that inhibits PD-L1, and is being tested across several tumour types in early phase clinical trials.
APPLE is a single centre open label, non-randomized, non-placebo phase 1 clinical trial to establish the safety and tolerability of Avelumab in combination with radiotherapy in patients with advanced soft tissue sarcomas (STS). Metastatic STS patients receiving radiotherapy to a tumour deposit above the diaphragm in the thorax, trunk or extremity will receive hypofractionated. This study will recruit 12 patients and run as a dose escalation trial with the 12 patients comprising the expansion cohort once the maximum tolerated dose has been defined.
The study is sponsored by the Royal Marsden Hospital and funded Merck KGaA. The study period is 36 months and Royal Marsden Hospital will be the research site.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
18/LO/0240
Date of REC Opinion
6 Jun 2018
REC opinion
Further Information Favourable Opinion