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ATHENA - Rucaparib and Nivolumab for Maintenance in Ovarian Cancer

Clinicaltrials.gov identifier:
NCT03522246

Treatment

Study Contact Information:

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


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 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, , multinational, double-blind, dual , 4-arm study evaluating  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 repair gene mutation status of tumor samples.

  • This is a  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 rucaparib (also known as ) orally twice daily and the agent nivolumab (also known as Opdivo) intravenously every 4 weeks

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

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

    • Group D will receive a orally twice daily and a  every 4 weeks.

  • A majority of patients will receive with nivolumab or with (Groups A and B) – the randomization is 4:4:1:1 between Groups A, B, C, and D.

  • The study is . 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 , nivolumab, or  while participating in the study. 

  • The study is . Three of the four groups include a . 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  III/IV ovarian, , 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 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 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 or 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.

 

This Study is Open To:

UPDATE: THIS STUDY IS NO LONGER ENROLLING PATIENTS

This Study is Not Open To: