ATHENA: A Study in Ovarian Cancer Patients Evaluating Rucaparib & Nivolumab as Maintenance Treatment
29 July 2019
ATHENA is a study for women who are newly diagnosed with ovarian cancer. The goal of ATHENA is to assess if giving maintenance therapy with two targeted anti-cancer agents (PARP inhibitor rucaparib and/or immunotherapy drug nivolumab) improves outcomes for women who have completed firstline treatment.
About the Study
The experimental combination of drugs being investigated in this study are called rucaparib and nivolumab.
Rucaparib (trade name: Rubraca) is a medicine that is approved in the European Union (EU) and the US for use in certain types of ovarian cancer. Clovis Oncology continues to study rucaparib in several types of cancers, by itself as well as in combination with other drugs. Rucaparib however has not yet been approved by the Australian Health Authority, the Therapeutic Goods Administration (TGA), for use in Australian patients outside of a clinical study like this one.
Nivolumab is approved in Australia to treat other cancers. Nivolumab however has not yet been approved by the Therapeutic Goods Administration (TGA), to treat high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer in Australian patients outside of a clinical study like this one.
Rucaparib belongs to a class of anti-cancer agents known as PARP inhibitors. PARP is a protein inside cells that helps repair damage to deoxyribonucleic acid (DNA), which is the genetic material that carries the instructions for your body’s growth and development, and allows cells to continue on living. Cancer can result when there are changes in a person’s genetic material (sometimes called DNA mutations) that can cause cancer cells to grow out of control. Research has shown that PARP inhibitors stop the PARP protein from working, and that can sometimes cause cancer cells to stop growing. The tablet form of rucaparib has been given to over 1000 patients with cancer.
This Study is Open to:
Private and public patients with newly diagnosed Stage III/IV, high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who have completed cytoreductive surgery and had a complete or partial response to first-line platinum chemotherapy.
Type of Study
ATHENA is a Phase 3, randomized, multinational, double-blind, dual placebo-controlled, 4-arm study evaluating rucaparib and nivolumab 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 repair gene mutation status of tumor samples.
This is a randomized study, which means that participants will be placed into one of the four treatment groups by chance. Neither patients nor the treating doctor will choose the group participants are placed in.
The study has four arms. This means that patients in the study are placed in one of four different groups.
- Group A will receive the PARP inhibitor rucaparib orally twice daily and the immunotherapy agent nivolumab intravenously every 4 weeks
- Group B will receive the PARP inhibitor rucaparib orally twice daily and a placebo intravenously every 4 weeks.
- Group C will receive nivolumab intravenously every 4 weeks and a placebo orally twice daily.
- Group D will receive a placebo orally twice daily and a placebo intravenously every 4 weeks.
A majority of patients will receive rucaparib with nivolumab or rucaparib with placebo (Groups A and B) – the randomization is 4:4:1:1 between Groups A, B, C, and D.
The study is double-blinded meaning that neither the participants nor their doctors will know whether they are receiving rucaparib, nivolumab, or placebo while participating in the study.
The study is placebo-controlled. Three of the four groups include a placebo. Placebos are a substance not containing an active agent therefore participants may receive oral placebo tablets or inert solution for intravenous injections. Placebos are only used in research in situations where there is no standard treatment. Patients begin the study only after they complete standard front-line treatment and only if they respond to that treatment.
What the Study Entails
Women will be randomized to one of the four groups and receive treatment according to the group they are assigned to.
Patients will receive the IV dose of nivolumab or placebo on Day 1 of each 28-day cycle until disease progression or treatment discontinuation for other reason for up to 24 months of treatment.
Patients will receive oral rucaparib or placebo for continued twice daily dosing until disease progression or treatment discontinuation for other reason.
Patients will receive a safety follow-up at 28 and 100 days after the last dose of IV and/or oral study treatment.
Patients will be monitored every 12 weeks for 3 years and then every 24 weeks thereafter for disease assessment, survival, subsequent treatment and secondary malignancies.
ATHENA is an international trial conducted in the USA, Europe and Australia. There are ten trial sites in Australia. Burnside Hospital is the only location in South Australia.
Principal Investigator: Prof Martin K. Oehler
Co-Investigator: Dr Meena Okera
Trial-Coordinators: Diana Caruso, Cheryl Lennon