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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03522246




Registration number
NCT03522246
Ethics application status
Date submitted
9/04/2018
Date registered
11/05/2018
Date last updated
2/08/2019

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
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)
Secondary ID [1] 0 0
CO-338-087/GOG-3020/ENGOT-ov45
Universal Trial Number (UTN)
Trial acronym
ATHENA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epithelial Ovarian Cancer 0 0
Primary Peritoneal 0 0
Fallopian Tube Cancer 0 0
Newly Diagnosed 0 0
FIGO Stage III-IV 0 0
Partial Response 0 0
Complete Response 0 0
Condition category
Condition code
Cancer 0 0 0 0
Ovarian and primary peritoneal
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Interventional
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


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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Investigator assessed Progression-free survival (PFS)
Timepoint [1] 0 0
From randomization until disease progression (up to approximately 7 years)
Secondary outcome [1] 0 0
Blinded independent central review (BICR) PFS
Timepoint [1] 0 0
Every ~12 weeks after the start of combination treatment for ~3 years, then every ~24 weeks thereafter until disease progression. Study data collection expected to last for ~7 years
Secondary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
From enrollment to primary study completion of study (up to approximately 10 years)
Secondary outcome [3] 0 0
Objective response rate (ORR)
Timepoint [3] 0 0
For patients with measurable disease, every ~12 weeks after the start of combination treatment for ~3 years, then every ~24 weeks thereafter until disease progression. Study data collection expected to last for ~7 years
Secondary outcome [4] 0 0
Duration of response (DOR)
Timepoint [4] 0 0
For patients with measurable disease, every ~12 weeks after the start of combination treatment for ~3 years, then every ~24 weeks thereafter until disease progression. Study data collection expected to last for ~7 years
Secondary outcome [5] 0 0
Number of participants with treatment-emergent Adverse Events (AEs) as assessed by CTCAE v4 (or higher) as a measure of safety and tolerability
Timepoint [5] 0 0
Collected from the time patient receives first dose of study drug until post treatment safety follow-up period (up to approximately 10 years)
Secondary outcome [6] 0 0
Number of participants with serious AEs as a measure of safety and tolerability
Timepoint [6] 0 0
Collected from the time patient receives first dose of study drug until post treatment safety follow-up period (up to approximately 10 years)
Secondary outcome [7] 0 0
Number of participants with laboratory abnormalities as a measure of safety and tolerability
Timepoint [7] 0 0
Collected from the time patient receives first dose of study drug until post treatment safety follow-up period (up to approximately 10 years)

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
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
AUNSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Border Medical Oncology - Albury
Recruitment hospital [2] 0 0
Newcastle Private Hospital - New Lambton Heights
Recruitment hospital [3] 0 0
Northern Cancer Institute St Leonards - Saint Leonards
Recruitment hospital [4] 0 0
Prince of Wales Hospital - Sydney
Recruitment hospital [5] 0 0
Westmead Hospital - Westmead
Recruitment hospital [6] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [7] 0 0
Brian Fricker Oncology Centre, Burnside Hospital - Toorak Gardens
Recruitment hospital [8] 0 0
Peter MacCallum Cancer Center - Melbourne
Recruitment hospital [9] 0 0
St John of God Subiaco Hospital - Subiaco
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
2145 - New Lambton Heights
Recruitment postcode(s) [3] 0 0
2065 - Saint Leonards
Recruitment postcode(s) [4] 0 0
2031 - Sydney
Recruitment postcode(s) [5] 0 0
2145 - Westmead
Recruitment postcode(s) [6] 0 0
4020 - Brisbane
Recruitment postcode(s) [7] 0 0
5065 - Toorak Gardens
Recruitment postcode(s) [8] 0 0
3000 - Melbourne
Recruitment postcode(s) [9] 0 0
6005 - Subiaco
Recruitment outside Australia
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Arizona
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Massachusetts
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Michigan
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Aalborg
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Taoyuan
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Turkey
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Ankara
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Manisa
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United Kingdom
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Hampshire
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Kent
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London
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Middlesex
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Northampton
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Wirral
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Birmingham
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Brighton
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Dundee
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Edinburgh
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Lancaster
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Leeds
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Manchester
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Oxford
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Poole
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Preston
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Sutton
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Swansea
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Taunton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Clovis Oncology, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Bristol-Myers Squibb
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Gynecologic Oncology Group
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Commercial sector/Industry
Name [4] 0 0
Foundation Medicine
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT03522246
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bradley Monk, MD, FACS, FACOG
Address 0 0
Lead Investigator and Coordinating Investigator for North America
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Clovis Oncology Clinical Trial Information
Address 0 0
Country 0 0
Phone 0 0
1-855-262-3040 (USA)
Fax 0 0
Email 0 0
clovistrials@emergingmed.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03522246