A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy (ATHENA)

About the Study

ATHENA is a study for women who are newly diagnosed with ovarian cancer. The goal of ATHENA is to look at whether giving maintenance therapy with different agents improves outcomes for women who have completed front-line treatment. 

UPDATE: THIS STUDY IS NO LONGER ENROLLING PATIENTS

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 research 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 (also known as Rubraca) orally twice daily and the immunotherapy agent nivolumab (also known as Opdivo) intravenously every 4 weeks

  • Group B will receive the PARP inhibitor rucaparib (Rubraca) orally twice daily and a placebo intravenously every 4 weeks.

  • Group C will receive nivolumab (Opdivo) intravenously every 4 weeks and a placebo orally twice daily. 

  • Group D will receive a placebo orally twice daily and a placebo 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. This means that participants will be randomly assigned to one of four groups. 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 harmless oral sugar pills or inert solution for injections. Placebos are only used in research in situations where there is no standard treatment. Patients begin the study only after they complete standard treatment and only if they respond to treatment. 

What the Study Entails

• Newly diagnosed women with Stage III/IV ovarian, fallopian tube, or primary peritoneal cancer will qualify for the study providing they have sufficient tumor samples for analysis and had a partial or complete response to front line platinum chemotherapy. 
• 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 will be administered 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 the oral dose of rucaparib or placebo will be continued twice daily until disease progression or treatment discontinuation for other reason.
• Women will receive a safety follow-up at 28 and 100 days after the last dose of IV and/or oral study treatment.
• Women will be monitored every 12 weeks for 3 years and then every 24 weeks thereafter for disease assessment, survival, subsequent treatment and secondary malignancies. 

Study Sites

The ATHENA study is open at many locations across the United States and around the world. For a full list of open sites, contact Clovis Oncology Clinical Trial Information Line at: 1-855-262-3040 (USA) or +1-303-625-5160 (ex-USA), or by email.