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Closed (no longer recruiting)Last updated: 1 February 2024

ATHENA: This phase III trial is evaluating an oral drug (Rucaparib) and an intravenous immunotherapy drug (Nivolumab) as maintenance therapy for newly diagnosed ovarian cancer patientsA 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

Clinical summary

Summary

This is a randomised, multinational, double blind, dual placebo controlled, 4-arm study of Rucaparib and Nivolumab. Oral Rucaparib and the oral placebo drug will be administered twice daily. Intravenous Nivolumab and intravenous placebo will be administered once every four weeks.

Conditions

This trial is treating patients with ovarian, fallopian tube or primary peritoneal cancer.

Cancer

Female Reproductive System Cancers Gynaecological

Age

People18+

Phase

III

Trial Acronym

ATHENA

More information

Trial Identifiers

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Trial sponsor

Clovis Oncology, Inc.

Scientific 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

Eligibility

Inclusion

  • Newly diagnosed advanced (FIGO stage III-IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer.
  • Completed cytoreductive surgery, including at least a bilateral salpingo-oophorectomy and partial omentectomy, either prior to chemotherapy (primary surgery) or following neoadjuvant chemotherapy (interval debulking)
  • Completed first-line platinum-based chemotherapy and surgery with a response, in the opinion of the Investigator
  • Sufficient tumor tissue for planned analysis
  • ECOG performance status of 0 or 1
  • Patients must be 20 years of age to consent in Japan, Taiwan and South Korea; in all other participating countries patients must be 18 years of age to consent

Exclusion

  • Pure sarcomas or borderline tumors or mucinous tumors
  • Active second malignancy
  • Known central nervous system brain metastases
  • Any prior treatment for ovarian cancer, other than the first-line platinum regimen
  • Evidence of interstitial lung disease or active pneumonitis
  • Active, known or suspected autoimmune disease
  • Condition requiring active systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications

Inclusion

  • You have had a certain type of treatment or surgical procedure.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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