An international phase III randomised study to evaluate the efficacy of maintenance therapy with olaparib and cediranib or olaparib alone in patients with relapsed platinum-sensitive ovarian cancer following a response to platinum-based chemotherapy
Description
Design:
ICON9 is an international phase III randomised study to evaluate the efficacy of maintenance olaparib and cediranib combination therapy or olaparib alone in patients with relapsed platinum-sensitive ovarian cancer following a response to platinum-based chemotherapy.
Treatment:
Women whose disease responds to platinum-based chemotherapy following 3 to 4 cycles can be registered for HRD testing of archival tumour specimens. Following a response (partial/complete response) to platinum-based chemotherapy (4-6 cycles) for first recurrence of platinum sensitive relapsed ovarian/fallopian tube/primary peritoneal cancer, patients will be randomised to receive one of the following two arms:
Arm 1 – Oral olaparib 300mg twice daily and cediranib 20mg once daily.
Arm 2 - Oral olaparib 300mg twice daily.
The regimen may be continued beyond progression until trial closure if the patient is deemed to still be deriving clinical benefit.
Key inclusion/exclusion criteria:
Patients must have a histologically proven diagnosis of high grade serous or endometrioid carcinoma of the ovary, fallopian tube or peritoneum, progressing more than 6 months after day 1 of the last cycle of first-line platinum-based chemotherapy and requiring treatment with second-line platinum-based chemotherapy. All patients must have completed a minimum of 4 cycles of platinum-based chemotherapy for first relapse (2nd line treatment) with at least a partial response on imaging (CT or MRI) by RECIST 1.1 if measureable disease or CA125 response by GCIG criteria if non-measurable disease.
Patients with non-epithelial ovarian cancer, carcinosarcoma and mucinous carcinomas or ovarian clear-cell carcinoma and evidence of severe or uncontrolled cardiac disease are not eligible.
Duration of recruitment:
Anticipated 4 years recruitment and 3 years follow up.
Aim
ICON9 will assess the efficacy, safety and tolerability of maintenance olaparib in combination with cediranib compared to maintenance olaparib alone following a response to platinum-based chemotherapy in women with relapsed platinum-sensitive ovarian, fallopian tube or peritoneal cancer. Prognostic and predictive factors will be studied from tumour and blood samples.