VHIO VHIO17002 - Phase II, Multicentre, Basket of Baskets solid tumour
Research type
Research Study
Full title
Basket of Baskets: A Modular, Open-label, Phase II, Multicentre Study To Evaluate Targeted Agents in Molecularly Selected Populations With Advanced Solid Tumours.
IRAS ID
247548
Contact name
Richard Baird
Contact email
Sponsor organisation
Vall d'Hebron Institute of Oncology (VHIO)
Eudract number
2017-005108-89
Duration of Study in the UK
2 years, 3 months, 31 days
Research summary
This study has two parts, part A (iPROFILER)and part B (iBASKET). The purpose of part A (iPROFILER) of this study is to test the participants’ tumour tissue to identify whether their tumour has certain mutations in cancer-related genes. It is known that gene mutations of tumours contribute to their origin and growth and determine whether the tumour will respond to particular cancer drugs. This test will provide information about potential targeted therapies that specifically attack those gene mutations. The purpose of part B (iBASKET)of this study is to offer participants a personalised anti-cancer treatment based on the gene mutations that are found in their tumour. Participants taking part in this module 1 of part B (iBASKET), in genomically selected populations, will receive atezolizumab 1200mg intravenously every 3 weeks, following the analysis of their tumour in part A (iPROFILER). Participants will be able to take atezolizumab for as long as their tumour doesn’t grow and for as long as they don’t have any side-effects which prevent them from continuing treatment.\n\nThe study will have a 2-year recruitment period. The aim of the study is to determine which genomically selected populations respond effectively to the targeted treatment, atezolizumab. Approximately 1000 participants will be enrolled into part A (iPROFILER), with approximately 100 participants being recruited into module 1 of part B (iBASKET).\n
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
18/YH/0295
Date of REC Opinion
11 Oct 2018
REC opinion
Further Information Favourable Opinion