Project: Data solutions based on a basket prospective trial with pembrolizumab and Vorinostat in patients with advanced and/or recurrent squamous cell carcinoma

Acronym	PEVO data (Reference Number: ERAPERMED2018-078)
Duration	01/03/2019 - 28/02/2022
Project Topic	Cancers that differ in terms of locations and histologies can harbour similar molecular features. Squamous cell carcinomas (SCCs) as an example may originate from various tumor locations and are sometimes related to HPV. For the first time in the history of oncology, a drug has been approved by the FDA in 2017 across tumor types based on a molecular alteration (i.e. pembrolizumab in MSi-high tumors). So far, we have infrequently been able to cure late stage cancers with medical treatments. Late stage cancers acquire multiple drug resistance mechanisms and thus a combination of drugs may be needed for treatment, making the discovery of a cure for late stage disease extremely challenging. Integration of multiple molecular data with patients clinical history is today crucial to apprehend new mechanisms related to drug efficacy or resistance. Via the PEVOSQ basket trial with pembrolizumab in combination with vorinostat in patients with advanced and/or recurrent SCC of various tumor locations and the assessment of molecular and clinical data at different time points, we aim to: 1) explore the modification of immune-related and molecular-epigenetic biomarkers treatment; 2) build a database integrating molecular and clinical profiles for treatment decision; develop long-term standards alongside other strategies for data collection and management to produce high-quality data with appropriate metadata and provenance, and 3) establish patient doctor interactions via an IT portal. Our ambition is to enable investigators to leverage all possible data and tools in the effort to accelerate biomedical discoveries, therapies and cures driving the development of data infrastructure and data science capabilities through collaborative research and robust engineering based on a real life prospective clinical trial. With this project we will provide a proof-of-concept for the importance of integrating molecular data to accelerate patient enrolment in clinical trials.
Network	ERA PerMed
Call	1st Joint Transnational Call for Proposals (2018)

Project partner

Number	Name	Role	Country
1	Institut Curie	Coordinator	France
2	Integrated BioBank of Luxembourg	Partner	Luxembourg
3	Leipzig University	Partner	Germany
4	Unicancer	Partner	France
5	Istituto Europeo di Oncologia	Partner	Italy
6	Oncompass Medicine Hungary Kft	Partner	Hungary