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Research type
Research Study
Full title
Treatment resistance following anti-cancer therapies
IRAS ID
257037
Contact name
Helen Cardy
Contact email
Sponsor organisation
Pfizer
Duration of Study in the UK
1 years, 7 months, 16 days
Research summary
This is a multi-national, multi-centre study to collect and analyse pretreatment tumour specimens (i.e., stored tumor samples from a previous biopsy or surgery) and post-progression biospecimens (i.e., new tumour biopsy and blood samples) from patients with advanced or metastatic cancer whose disease has progressed on their most recent anti-cancer therapy. \n\nApproximately 550 patients globally will participate in the study. \n\nThe overall objective of the study is to better understand why tumours become resistant to selected anti-cancer therapies that target critical aspects of tumor biology. Understanding mechanisms of tumour resistance is critical to developing better anti-cancer treatments and treatment combinations. Studying potential factors that drive tumor resistance has been challenging because of very limited post-progression tumor tissue availability. The current study seeks to address this key challenge of obtaining critical tissue samples needed to understand the tumour microenvironment and expand upon earlier preclinical and smaller clinical studies. \n\nOnly those patients who meet the study requirements will be eligible to participate in the study consisting of a study-related tumor biopsy and blood draw and a post-biopsy follow-up visit. Molecular tests will be performed on the pretreatment tissue and post-progression biospecimens, including Next Generation Sequencing (NGS), analyses. As part of study participation, results from the NGS analysis from the post-progression biopsy and/or blood biospecimens will be returned to the patient’s treating physician/health care provider. Results will come from using a commercially available NGS test. A study-specific follow-up consultation between the treating physician and patient will be conducted to discuss the NGS results and potential treatment options. All treatment decisions will be made by the treating physician as part of the patients regular clinical care. \n\nBrief patient and physician assessment questionnaires will also be conducted at the end to assess perceived value of study participation.\n
REC name
South West - Central Bristol Research Ethics Committee
REC reference
19/SW/0090
Date of REC Opinion
30 May 2019
REC opinion
Further Information Favourable Opinion