AARDVARC
Research type
Research Study
Full title
A Phase II, Open-label, Study to Assess the Efficacy, Safety, and Tolerability of AZD4635 in Combination with Durvalumab and in Combination with Cabazitaxel and Durvalumab in Patients Who Have Progressive Metastatic Castrate-Resistant Prostate Cancer (AARDVARC)
IRAS ID
285958
Contact name
Charlotte Pai
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2020-000209-10
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
138166, Investigational New Drug (IND) Number
Duration of Study in the UK
1 years, 6 months, 9 days
Research summary
Research Summary
Prostate cancer is the second most common cancer in men. For men requiring systemic therapy, hormonal therapy has been the mainstay. Once the disease becomes resistant to hormonal therapy, the disease is known as castration-resistant prostate cancer (mCRPC). However, many of the treatments for prostate cancer, including Docetaxel and Cabazitaxel for mCRPC, are not suitable for all patients and many patients are resistant to these treatments so alternative treatment options are needed.
Currently, mCRPC remains incurable, and many treatment options are palliative in nature. Some agents may be administered in combination with steroids, such as Prednisone, which has been shown to decrease testosterone levels and reduce tumour growth as well as counteract adverse events.
While immunotherapy has led to impressive responses in a subset of patients with immunologically "activated" tumours, this approach has shown little progress in mCRPC. AZD4635 (study drug) appears to have increased efficacy in combination with anti-PD-L1 (inhibitors - inhibitors are emerging as a front-line treatment for several types of cancer in patients with mCRPC who have exhausted standard of care options)
The intention is to recruit 160 patients in this study, across approximately 50 global sites in Europe, South Korea, the UK, and the USA
This clinical research study is being sponsored by Astra Zeneca.
Summary of Results
The Lay Summary for the study has been made available on https://gbr01.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.trialsummaries.com%2F&data=05%7C01%7Cedgbaston.rec%40hra.nhs.uk%7C28ebacce537b4ed883cd08dbad5e7a1f%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638294393498825069%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=RoD80JAPItJqvxojCQslhb4txDEObR2DwBCkcblIIdQ%3D&reserved=0.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
20/WM/0328
Date of REC Opinion
3 Feb 2021
REC opinion
Further Information Favourable Opinion