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

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ClinicalTrials.gov Identifier: NCT03522246
Recruitment Status : Recruiting
First Posted : May 11, 2018
Last Update Posted : August 2, 2019
Sponsor:
Collaborators:
Bristol-Myers Squibb
Gynecologic Oncology Group
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Foundation Medicine
Information provided by (Responsible Party):
Clovis Oncology, Inc.

Tracking Information
First Submitted Date  ICMJE April 9, 2018
First Posted Date  ICMJE May 11, 2018
Last Update Posted Date August 2, 2019
Actual Study Start Date  ICMJE May 14, 2018
Estimated Primary Completion Date December 30, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2018)
Investigator assessed Progression-free survival (PFS) [ Time Frame: From randomization until disease progression (up to approximately 7 years) ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 30, 2018)
Investigator assessed Progression-free survival (PFS) [ Time Frame: From randomization until disease progression (up to approximately 10 years) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2018)
  • Blinded independent central review (BICR) PFS [ Time Frame: 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 ]
  • Overall Survival (OS) [ Time Frame: From enrollment to primary study completion of study (up to approximately 10 years) ]
  • Objective response rate (ORR) [ Time Frame: 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 ]
  • Duration of response (DOR) [ Time Frame: 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 ]
  • Number of participants with treatment-emergent Adverse Events (AEs) as assessed by CTCAE v4 (or higher) as a measure of safety and tolerability [ Time Frame: Collected from the time patient receives first dose of study drug until post treatment safety follow-up period (up to approximately 10 years) ]
  • Number of participants with serious AEs as a measure of safety and tolerability [ Time Frame: Collected from the time patient receives first dose of study drug until post treatment safety follow-up period (up to approximately 10 years) ]
  • Number of participants with laboratory abnormalities as a measure of safety and tolerability [ Time Frame: Collected from the time patient receives first dose of study drug until post treatment safety follow-up period (up to approximately 10 years) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double-Blind
Primary Purpose: Treatment
Condition  ICMJE
  • Epithelial Ovarian Cancer
  • Primary Peritoneal
  • Fallopian Tube Cancer
  • Newly Diagnosed
  • FIGO Stage III-IV
  • Partial Response
  • Complete Response
Intervention  ICMJE
  • Drug: Rucaparib
    Oral rucaparib will be administered twice daily
    Other Names:
    • Rubraca
    • CO-338
  • Drug: Nivolumab
    IV nivolumab will be administered once every 4 weeks
    Other Names:
    • Opdivo
    • BMS-936558
  • Drug: Placebo Oral Tablet
    Placebo tablets will be administered twice daily
  • Drug: Placebo IV Infusion
    IV placebo will be administered once every 4 weeks
Study Arms  ICMJE
  • Experimental: Arm A
    oral rucaparib + intravenous (IV) nivolumab
    Interventions:
    • Drug: Rucaparib
    • Drug: Nivolumab
  • Experimental: Arm B
    oral rucaparib+IV placebo
    Interventions:
    • Drug: Rucaparib
    • Drug: Placebo IV Infusion
  • Experimental: Arm C
    oral placebo+ IV nivolumab
    Interventions:
    • Drug: Nivolumab
    • Drug: Placebo Oral Tablet
  • Placebo Comparator: Arm D
    Oral placebo + IV placebo
    Interventions:
    • Drug: Placebo Oral Tablet
    • Drug: Placebo IV Infusion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 30, 2018)
1012
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2030
Estimated Primary Completion Date December 30, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Clovis Oncology Clinical Trial Information 1-855-262-3040 (USA) clovistrials@emergingmed.com
Contact: Clovis Oncology Clinical Trial infomration +1-303-625-5160 (ex-USA) clovistrials@emergingmed.com
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   Denmark,   Finland,   Greece,   Ireland,   Israel,   Italy,   Japan,   Korea, Republic of,   New Zealand,   Poland,   Romania,   Russian Federation,   Singapore,   Spain,   Taiwan,   Turkey,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03522246
Other Study ID Numbers  ICMJE CO-338-087/GOG-3020/ENGOT-ov45
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Clovis Oncology, Inc.
Study Sponsor  ICMJE Clovis Oncology, Inc.
Collaborators  ICMJE
  • Bristol-Myers Squibb
  • Gynecologic Oncology Group
  • European Network of Gynaecological Oncological Trial Groups (ENGOT)
  • Foundation Medicine
Investigators  ICMJE
Principal Investigator: Bradley Monk, MD, FACS, FACOG Lead Investigator and Coordinating Investigator for North America
Principal Investigator: Rebecca Kristeleit, Bsc MBChB FRCP PhD Coordinating Investigator for Europe, Middle East, and all Other Regions
PRS Account Clovis Oncology, Inc.
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP