ATHENA - a first line ovarian cancer maintenance trial.
Research type
Research Study
Full title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy
IRAS ID
240011
Contact name
Dr Rebecca Kristeleit
Contact email
Sponsor organisation
pharmaand GmbH
Eudract number
2017-004557-17
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
GOG-3020, GOG; ENGOT-ov45/NCRI/ATHENA, ENGOT
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
This is a randomised, double-blind, placebo-controlled four-arm, Phase-3 study of ovarian cancer patients.
The aim of the study is to investigate a treatment for newly diagnosed, high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer patients who have completed first line platinum-based chemotherapy
The experimental combination of drugs being investigated in this study are called rucaparib and nivolumab.
Rucaparib is being developed by sponsor, Clovis Oncology, Inc., a biopharmaceutical company with headquarters in the United States (US). Rucaparib is approved for treatment in the US for patients with ovarian cancer who have been treated with two or more chemotherapy regimens and are found to have a BRCA 1 or BRCA 2 mutation (also known as the breast cancer susceptibility genes). In addition, Rucaparib was approved on April 6, 2018 for maintenance treatment of recurrence for patients who responded to platinum-based therapy.
Rucaparib belongs to a class of anti-cancer agents known as PARP inhibitors. PARP is a protein inside cells that helps repair damage to DNA, which is the genetic material that carries the instructions for body growth and development, and allows cells to continue on living.
Nivolumab is a product of Bristol-Myers Squibb and is approved in many regions, including the US and EU, for different types of cancer but not for ovarian cancer.
Nivolumab is being studied both as monotherapy, the treatment of disease as a single drug, and in combination with other drugs. Nivolumab is an anti-programmed death receptor-(PD)-1 inhibitor which interacts with markers on the surface of the cells. Markers are like flags that help cells identify each other.
Sometimes cancer cells have the PD-L1 and/or PD-L2 marker which attach to the PD-1 receptors on T cells, a type of white blood cell found in the immune system which identifies and attacks foreign cells or viruses. This interaction hides cancer cells and tells T cells to become inactive and not to attack. Nivolumab can block cancer’s ability to hide itself and helps the T cells to be active and attack cancer cells again.
Approximately 1000 patients with newly diagnosed ovarian cancer will participate in this study at about 230 centres worldwide in Australia, Belgium, Canada, Denmark, Finland, Germany, Greece, Ireland, Israel, Italy, Japan, New Zealand, Poland, Romania, Russia, Singapore, South Korea, Spain, Sweden, Taiwan, Turkey, Ukraine, United Kingdom & United States. The study will take about 5 years to complete.
The maximum amount of time that participants will be on the study is 60 months of which they will be on the study treatment for a maximum of 25 months.REC name
London - Chelsea Research Ethics Committee
REC reference
18/LO/1187
Date of REC Opinion
17 Jul 2018
REC opinion
Favourable Opinion