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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03522246
Registration number
NCT03522246
Ethics application status
Date submitted
9/04/2018
Date registered
11/05/2018
Date last updated
24/06/2025
Titles & IDs
Public title
A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy
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Scientific 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)
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Secondary ID [1]
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2017-004557-17
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Secondary ID [2]
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CO-338-087/GOG-3020/ENGOT-ov45
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Universal Trial Number (UTN)
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Trial acronym
ATHENA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Epithelial Ovarian Cancer
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Primary Peritoneal
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Fallopian Tube Cancer
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Newly Diagnosed
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FIGO Stage III-IV
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Partial Response
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Complete Response
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Condition category
Condition code
Cancer
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Ovarian and primary peritoneal
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Cancer
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Womb (Uterine or endometrial cancer)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Rucaparib
Treatment: Drugs - Nivolumab
Treatment: Drugs - Placebo Oral Tablet
Treatment: Drugs - Placebo IV Infusion
Experimental: Arm A - Oral rucaparib + intravenous (IV) nivolumab
Experimental: Arm B - Oral rucaparib + IV placebo
Experimental: Arm C - Oral placebo + IV nivolumab
Placebo comparator: Arm D - Oral placebo + IV placebo
Experimental: Japanese Open-label Safety Cohort - Oral rucaparib + IV nivolumab
Treatment: Drugs: Rucaparib
Oral rucaparib will be administered twice daily
Treatment: Drugs: Nivolumab
IV nivolumab will be administered once every 4 weeks
Treatment: Drugs: Placebo Oral Tablet
Placebo tablets will be administered twice daily
Treatment: Drugs: Placebo IV Infusion
IV placebo will be administered once every 4 weeks
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Monotherapy Arm B and Arm D: Investigator Assessed Progression-free Survival (PFS)
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Assessment method [1]
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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).
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Timepoint [1]
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From randomization until disease progression (up to the primary data analysis at approximately 39 months)
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Primary outcome [2]
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Monotherapy Arm B and Arm D: Investigator Assessed PFS
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Assessment method [2]
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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).
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Timepoint [2]
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From randomization until disease progression (up to the primary data analysis at approximately 39 months)
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Primary outcome [3]
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Combination Therapy Arm A and Arm B: Investigator Assessed PFS
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Assessment method [3]
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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).
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Timepoint [3]
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From randomization until disease progression (up to the combination therapy interim analysis at approximately 66 months)
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Secondary outcome [1]
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Monotherapy Arm B and Arm D: Blinded Independent Central Review (BICR) PFS
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Assessment method [1]
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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).
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Timepoint [1]
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From randomization until disease progression (up to the primary data analysis at approximately 39 months)
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Secondary outcome [2]
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Monotherapy Arm B and Arm D: BICR PFS
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Assessment method [2]
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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).
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Timepoint [2]
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From randomization until disease progression (up to the primary data analysis at approximately 39 months)
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Secondary outcome [3]
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Combination Therapy Arm A and Arm B: BICR PFS
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Assessment method [3]
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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).
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Timepoint [3]
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From randomization until disease progression (up to the combination therapy interim analysis at approximately 66 months)
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Secondary outcome [4]
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Monotherapy Arm B and Arm D: Overall Survival (OS)
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Assessment method [4]
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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.
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Timepoint [4]
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From randomization until death due to any cause (up to the primary data analysis at approximately 36 months)
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Secondary outcome [5]
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Monotherapy Arm B and Arm D: OS
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Assessment method [5]
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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.
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Timepoint [5]
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From randomization until death due to any cause (up to the primary data analysis at approximately 40 months)
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Secondary outcome [6]
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Combination Therapy Arm A and Arm B: OS
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Assessment method [6]
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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.
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Timepoint [6]
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From randomization until death due to any cause (up to the combination therapy interim analysis at approximately 72 months)
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Secondary outcome [7]
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Monotherapy Arm B and Arm D: Objective Response Rate (ORR)
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Assessment method [7]
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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.
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Timepoint [7]
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From randomization until disease progression (up to the primary data analysis at approximately 39 months)
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Secondary outcome [8]
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Monotherapy Arm B and Arm D: ORR
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Assessment method [8]
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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.
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Timepoint [8]
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From randomization until disease progression (up to the primary data analysis at approximately 39 months)
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Secondary outcome [9]
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Combination Therapy Arm A and Arm B: ORR
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Assessment method [9]
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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.
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Timepoint [9]
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From randomization until disease progression (up to the combination therapy interim analysis at approximately 66 months)
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Secondary outcome [10]
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Monotherapy Arm B and Arm D: Duration of Response (DOR)
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Assessment method [10]
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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).
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Timepoint [10]
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From first confirmed response until disease progression (up to the primary data analysis at approximately 30 months)
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Secondary outcome [11]
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Monotherapy Arm B and Arm D: DOR
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Assessment method [11]
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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).
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Timepoint [11]
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From first confirmed response until disease progression (up to the primary data analysis at approximately 33 months)
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Secondary outcome [12]
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Combination Therapy Arm A and Arm B: DOR
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Assessment method [12]
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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).
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Timepoint [12]
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From first confirmed response until disease progression (up to the combination therapy interim analysis at approximately 60 months)
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
14/05/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/12/2030
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Actual
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Sample size
Target
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Accrual to date
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Final
1097
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Newcastle Private Hospital - New Lambton Heights
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Recruitment hospital [2]
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Northern Cancer Institute St Leonards - Saint Leonards
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Recruitment hospital [3]
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Prince of Wales Hospital - Sydney
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Recruitment hospital [4]
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Westmead Hospital - Westmead
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Recruitment hospital [5]
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Royal Brisbane and Women's Hospital - Brisbane
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Recruitment hospital [6]
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Brian Fricker Oncology Centre, Burnside Hospital - Toorak Gardens
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Recruitment hospital [7]
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Peter MacCallum Cancer Center - Melbourne
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Recruitment hospital [8]
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St John of God Subiaco Hospital - Subiaco
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Recruitment postcode(s) [1]
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2145 - New Lambton Heights
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Recruitment postcode(s) [2]
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2065 - Saint Leonards
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Recruitment postcode(s) [3]
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2031 - Sydney
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Recruitment postcode(s) [4]
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2145 - Westmead
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Recruitment postcode(s) [5]
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4020 - Brisbane
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Recruitment postcode(s) [6]
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5065 - Toorak Gardens
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Recruitment postcode(s) [7]
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3000 - Melbourne
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Recruitment postcode(s) [8]
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6005 - Subiaco
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Recruitment outside Australia
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Japan
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Chiba
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Fukuoka
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Iwate
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Szczecin
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Romania
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Russian Federation
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Linköping
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Yuregir
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Kent
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Northampton
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Poole
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Taunton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
pharmaand GmbH
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Bristol-Myers Squibb
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Other
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Gynecologic Oncology Group
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Other
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European Network of Gynaecological Oncological Trial Groups (ENGOT)
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Foundation Medicine
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Ethics approval
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Summary
Brief summary
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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Trial website
https://clinicaltrials.gov/study/NCT03522246
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Trial related presentations / publications
Monk BJ, Parkinson C, Lim MC, O'Malley DM, Oaknin A, Wilson MK, Coleman RL, Lorusso D, Bessette P, Ghamande S, Christopoulou A, Provencher D, Prendergast E, Demirkiran F, Mikheeva O, Yeku O, Chudecka-Glaz A, Schenker M, Littell RD, Safra T, Chou HH, Morgan MA, Drochytek V, Barlin JN, Van Gorp T, Ueland F, Lindahl G, Anderson C, Collins DC, Moore K, Marme F, Westin SN, McNeish IA, Shih D, Lin KK, Goble S, Hume S, Fujiwara K, Kristeleit RS. A Randomized, Phase III Trial to Evaluate Rucaparib Monotherapy as Maintenance Treatment in Patients With Newly Diagnosed Ovarian Cancer (ATHENA-MONO/GOG-3020/ENGOT-ov45). J Clin Oncol. 2022 Dec 1;40(34):3952-3964. doi: 10.1200/JCO.22.01003. Epub 2022 Jun 6. Monk BJ, Coleman RL, Fujiwara K, Wilson MK, Oza AM, Oaknin A, O'Malley DM, Lorusso D, Westin SN, Safra T, Herzog TJ, Marme F, N Eskander R, Lin KK, Shih D, Goble S, Grechko N, Hume S, Maloney L, McNeish IA, Kristeleit RS. ATHENA (GOG-3020/ENGOT-ov45): a randomized, phase III trial to evaluate rucaparib as monotherapy (ATHENA-MONO) and rucaparib in combination with nivolumab (ATHENA-COMBO) as maintenance treatment following frontline platinum-based chemotherapy in ovarian cancer. Int J Gynecol Cancer. 2021 Dec;31(12):1589-1594. doi: 10.1136/ijgc-2021-002933. Epub 2021 Sep 30.
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Public notes
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Contacts
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No information has been provided regarding IPD availability
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No Supporting Document Provided
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/46/NCT03522246/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/46/NCT03522246/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03522246
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