Phase IB study of Rucaparib and Atezolizumab for gynaecologic cancers
Research type
Research Study
Full title
A Phase IB combination study of Rucaparib (CO-338) and Atezolizumab (MPDL3280A) in patients with advanced gynaecologic cancers and triple-negative breast cancer
IRAS ID
215913
Contact name
Rebecca Kristeleit
Contact email
Sponsor organisation
Roche Products Limited
Eudract number
2016-002610-47
Duration of Study in the UK
4 years, 9 months, 9 days
Research summary
Ovarian cancer is the leading cause of death attributed to gynaecological cancer. Most ovarian cancers are diagnosed at a late stage. Despite existing therapies, advanced ovarian cancer has a 5-year survival rate of only 30%−40%, therefore new treatments are needed.
Rucaparib is a new PARP inhibitor chemotherapy drug that has demonstrated effectiveness against ovarian cancer. Atezolizumab is a PD-L1 inhibitor drug that targets the immune system cells and enhances their response against cancer (immunotherapy). Atezolizumab has demonstrated effectiveness against a number of cancers including ovarian cancer.
This study will investigate the effects of Rucaparib and Atezolizumab given together.
Part 1 of the study will examine the safety of the combination in patients with advanced gynaecological cancers (ovarian or endometrial) who have received at least one line of prior therapy and define the recommended dose for Part 2.
Part 2 will further explore the safety and tolerability of the combined treatment at the recommended dose in patients with advanced ovarian cancer and certain genetic mutations who have received one or two platinum-based therapies.
Upon successful screening, the patients will enter the treatment phase where they will receive Atezolizumab as an infusion once every 3 weeks and take Rupacarib tablets twice daily. Part 2 has a 3-week Rupacarib run-in period before the combined treatment starts.
End of Treatment visit will be performed within 30 days of treatment discontinuation followed by 3-monthly survival follow-up.
Assessments for this study include physical examinations, ECG, blood and urine samples, tumour biopsy, tumour scans.
Up to 18 patients will participate in Part 1 and further 30 patients in Part 2. A UK and an Australian centre will participate in Part 1. Part 2 will include other countries.
The study will last for around 45 months. The patients are expected to be on the study for up to 24 months.REC name
London - Central Research Ethics Committee
REC reference
16/LO/2106
Date of REC Opinion
22 Dec 2016
REC opinion
Further Information Favourable Opinion