Clovis Oncology has randomised the first patient in the ATHENA trial, a Phase lll study investigating its Rubraca (rucaparib) in combination with and Bristol-Myers Squibb’s OPDIVO (nivolumab) for the treatment of advanced ovarian cancer.
The randomised, multinational, double-blind, placebo-controlled, four-arm trial is expected to enrol around 1,000 ovarian cancer patients at clinical trial sites across the US and internationally.
The trial is designed to examine the Rubraca and Opdivo combination as maintenance treatment following response to front-line treatment in newly diagnosed ovarian cancer patients.
Response to treatment will be evaluated based on homologous recombination (HR) status of tumour samples.
The trial’s primary endpoint is investigator-assessed progression-free survival (PFS), while its secondary endpoints comprise overall survival (OS), objective response rate (ORR), duration of response (DOR), and safety.
Sponsored by Clovis, the ATHENA trial is being conducted under a clinical collaboration between Bristol-Myers Squibb and Clovis.
Gynecologic Oncology Group (GOG) and the European Network for Gynecological Oncological Trials (ENGOT) are also involved in the trial.
ATHENA trial lead investigator Brad Monk said: “I am pleased the GOG and ENGOT are conducting the first trial designed to investigate whether the combination of a PARP inhibitor and PD-1 blocking antibody can demonstrate not only an improvement in progression-free survival in the first-line maintenance setting for women with advanced ovarian cancer, but also whether the combination can change the natural course of the disease by delaying or reducing recurrence following front-line therapy.”
Rubraca (rucaparib) is a poly (ADP ribose) polymerase inhibitor (PARP), while OPDIVO (nivolumab) is a PD-1 inhibitor.