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NCT Number: NCT03522246

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

This 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 analyzed based on homologous recombination (HR) status of tumor samples.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Epithelial Ovarian Cancer Adnexal Diseases Carcinoma Carcinoma, Ovarian Epithelial Complete Response Disease Attributes Disease Progression Endocrine Gland Neoplasms Endocrine System Diseases FIGO Stage III-IV Fallopian Tube Cancer Fallopian Tube Diseases Fallopian Tube Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Newly Diagnosed Ovarian Diseases Ovarian Neoplasms Partial Response Pathologic Complete Response Pathologic Processes Pathological Conditions, Signs and Symptoms Primary Peritoneal Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Newcastle Private Hospital, New Lambton Heights, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Rucaparib

Drug

Oral rucaparib will be administered twice daily

Other names: Rubraca, CO-338

Nivolumab

Drug

IV nivolumab will be administered once every 4 weeks

Other names: Opdivo, BMS-936558

Placebo oral tablet

Drug

Placebo tablets will be administered twice daily

Placebo IV Infusion

Drug

IV placebo will be administered once every 4 weeks

Primary outcomes

  1. Monotherapy Arm B and Arm D: Investigator Assessed Progression-free Survival (PFS)

    Time frame: From randomization until disease progression (up to the primary data analysis at approximately 39 months)

    PFS by investigator was defined as the time from randomization to disease progression, according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as assessed by the investigator, or death due to any cause, whichever occurred first.

    Progressive disease was defined as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).

  2. Monotherapy Arm B and Arm D: Investigator Assessed PFS

    Time frame: From randomization until disease progression (up to the primary data analysis at approximately 39 months)

    PFS by investigator was defined as the time from randomization to disease progression, according to RECIST v1.1 as assessed by the investigator, or death due to any cause, whichever occurred first.

    Progressive disease was defined as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).

  3. Combination Therapy Arm A and Arm B: Investigator Assessed PFS

    Time frame: From randomization until disease progression (up to the combination therapy interim analysis at approximately 66 months)

    PFS by investigator was defined as the time from randomization to disease progression, according to RECIST v1.1 as assessed by the investigator, or death due to any cause, whichever occurred first.

    Progressive disease was defined as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).

Secondary outcomes

  1. Monotherapy Arm B and Arm D: Blinded Independent Central Review (BICR) PFS

    Time frame: From randomization until disease progression (up to the primary data analysis at approximately 39 months)

    PFS was assessed by BICR per RECIST v1.1 as the time from randomization to disease progression, or death due to any cause, whichever occurred first.

    Progressive disease was defined as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).

  2. Monotherapy Arm B and Arm D: BICR PFS

    Time frame: From randomization until disease progression (up to the primary data analysis at approximately 39 months)

    PFS was assessed by BICR per RECIST v1.1 as the time from randomization to disease progression, or death due to any cause, whichever occurred first.

    Progressive disease was defined as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).

  3. Combination Therapy Arm A and Arm B: BICR PFS

    Time frame: From randomization until disease progression (up to the combination therapy interim analysis at approximately 66 months)

    PFS was assessed by BICR per RECIST v1.1 as the time from randomization to disease progression, or death due to any cause, whichever occurred first.

    Progressive disease was defined as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).

  4. Monotherapy Arm B and Arm D: Overall Survival (OS)

    Time frame: From randomization until death due to any cause (up to the primary data analysis at approximately 36 months)

    OS was defined as the number of days (measured in months) from the date of randomization to the date of death due to any cause.

  5. Monotherapy Arm B and Arm D: OS

    Time frame: From randomization until death due to any cause (up to the primary data analysis at approximately 40 months)

    OS was defined as the number of days (measured in months) from the date of randomization to the date of death due to any cause.

  6. Combination Therapy Arm A and Arm B: OS

    Time frame: From randomization until death due to any cause (up to the combination therapy interim analysis at approximately 72 months)

    OS was defined as the number of days (measured in months) from the date of randomization to the date of death due to any cause.

  7. Monotherapy Arm B and Arm D: Objective Response Rate (ORR)

    Time frame: From randomization until disease progression (up to the primary data analysis at approximately 39 months)

    ORR was defined as the percentage of participants with a confirmed Complete Response (CR) or Partial Response (PR) as assessed by the Investigator per RECIST 1.1.

    CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 mm.

    PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

  8. Monotherapy Arm B and Arm D: ORR

    Time frame: From randomization until disease progression (up to the primary data analysis at approximately 39 months)

    ORR was defined as the percentage of participants with CR or PR as assessed by the Investigator per RECIST 1.1.

    CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 mm.

    PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

  9. Combination Therapy Arm A and Arm B: ORR

    Time frame: From randomization until disease progression (up to the combination therapy interim analysis at approximately 66 months)

    ORR was defined as the percentage of participants with CR or PR as assessed by the Investigator per RECIST 1.1.

    CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 mm.

    PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

  10. Monotherapy Arm B and Arm D: Duration of Response (DOR)

    Time frame: From first confirmed response until disease progression (up to the primary data analysis at approximately 30 months)

    DOR was assessed by the investigator and defined as the interval from the first documentation of objective response (CR or PR per RECIST v1.1) to the earlier of the first documentation of progressive disease (PD) or death from any cause.

    CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 mm.

    PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

    PD: 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).

  11. Monotherapy Arm B and Arm D: DOR

    Time frame: From first confirmed response until disease progression (up to the primary data analysis at approximately 33 months)

    DOR was assessed by the investigator and defined as the interval from the first documentation of objective response (CR or PR per RECIST v1.1) to the earlier of the first documentation of PD or death from any cause.

    CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 mm.

    PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

    PD: 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).

  12. Combination Therapy Arm A and Arm B: DOR

    Time frame: From first confirmed response until disease progression (up to the combination therapy interim analysis at approximately 60 months)

    DOR was assessed by the investigator and defined as the interval from the first documentation of objective response (CR or PR per RECIST v1.1) to the earlier of the first documentation of PD or death from any cause.

    CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 mm.

    PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

    PD: 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).

Sponsors and collaborators

Lead sponsor

pharmaand GmbH

Industry

Collaborators

  • Bristol-Myers Squibb
  • European Network of Gynaecological Oncological Trial Groups (ENGOT)
  • Foundation Medicine
  • Gynecologic Oncology Group

Registry information

Official study title

ATHENA (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)

Acronym: ATHENA

Important dates

Study start
2018
Primary completion
2024
Study completion
2030
First posted
May 11, 2018
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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