AveAxiRCC (AA EAMS aRCC observational study)

Status: Open

Specialty: Renal

Date Opened: 01/09/2021

Planned Close Date: unknown

Sponsor: Pfizer

Principal Investigator: Dr Natalie Charnley

Study Title: An observational chart review study to describe the real-world outcomes and use of avelumab in combination with axitinib for treatment of patients with advanced renal cell carcinoma in the United Kingdom - Open Vie

This is a UK multi-centre observational study describing the real-world outcomes and use of avelumab in combination with axitinib (AA) for treatment of patients with advanced renal cell carcinoma (aRCC) in the United Kingdom (UK).

Kidney cancer is the UK’s seventh most common cancer. Renal cell carcinoma (RCC) is the most common subtype. 44% of kidney cancer cases are diagnosed as locally advanced (stage III) or metastatic (stage IV) disease. Outcomes for aRCC can be poor, with median overall survival (OS) as low as 6 months for those with metastatic disease.

Targeted cancer therapies are treatments that target proteins which control how cancer cells grow, divide, and spread. These include tyrosine kinase inhibitors (TKIs), e.g. axitinib, a molecule which can enter cells and block tumour growth. Another type of targeted therapy is immuno-oncology(IO) e.g. avelumab, which causes the patient’s own immune system to attack the tumour.

IO-TKI combination therapy is a recent advance in first-line treatment of aRCC. Following the successful JAVELIN clinical trial, which demonstrated improved progression free survival (PFS) in the AA combination therapy group compared with the sunitinib monotherapy group, AA combination therapy was made available to UK aRCC patients through an early access to medicines scheme (EAMS) in 2019. Subsequently, it was recommended by NICE, within the Cancer Drugs Fund, for untreated aRCC in adults and remains the only recommended IO-TKI option.

There is a paucity of data that describes the real-world demographics, treatment patterns, clinical characteristics and outcomes associated with AA combination therapy administered outside of a clinical trial setting. The current study (Sponsors Merck and Pfizer, marketing authorisation holders (MAH) of avelumab and axitinib respectively) aims to fill that evidence gap. Data will be collected from the medical records of up to 80 patients at 10-15 UK cancer care hospitals and analysed to determine real-world effectiveness.