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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 : June 28, 2018
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.

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.

Condition or disease Intervention/treatment Phase
Epithelial Ovarian Cancer Primary Peritoneal Fallopian Tube Cancer Newly Diagnosed FIGO Stage III-IV Partial Response Complete Response Drug: Rucaparib Drug: Nivolumab Drug: Placebo Oral Tablet Drug: Placebo IV Infusion Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1012 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-Blind
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : May 14, 2018
Estimated Primary Completion Date : December 30, 2024
Estimated Study Completion Date : December 30, 2030


Arm Intervention/treatment
Experimental: Arm A
oral rucaparib + intravenous (IV) nivolumab
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

Experimental: Arm B
oral rucaparib+IV placebo
Drug: Rucaparib
Oral rucaparib will be administered twice daily
Other Names:
  • Rubraca
  • CO-338

Drug: Placebo IV Infusion
IV placebo will be administered once every 4 weeks

Experimental: Arm C
oral placebo+ IV nivolumab
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

Placebo Comparator: Arm D
Oral placebo + IV placebo
Drug: Placebo Oral Tablet
Placebo tablets will be administered twice daily

Drug: Placebo IV Infusion
IV placebo will be administered once every 4 weeks




Primary Outcome Measures :
  1. Investigator assessed Progression-free survival (PFS) [ Time Frame: From randomization until disease progression (up to approximately 7 years) ]

Secondary Outcome Measures :
  1. 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 ]
  2. Overall Survival (OS) [ Time Frame: From enrollment to primary study completion of study (up to approximately 10 years) ]
  3. 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 ]
  4. 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 ]
  5. 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) ]
  6. 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) ]
  7. 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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03522246


Contacts
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

Locations
United States, Arizona
Arizona Oncology (US Oncology Network) Not yet recruiting
Phoenix, Arizona, United States, 85016
Contact: Bradley Monk, MD, FACS, FACOG         
United States, New York
Womens Cancer Care Associates Recruiting
Albany, New York, United States, 12208
United Kingdom
University College London Not yet recruiting
London, United Kingdom, WCIE 6DD
Contact: Rebecca Kristeleit, Msc, MBChB, FRCP, PhD         
Sponsors and Collaborators
Clovis Oncology, Inc.
Bristol-Myers Squibb
Gynecologic Oncology Group
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Foundation Medicine

Responsible Party: Clovis Oncology, Inc.
ClinicalTrials.gov Identifier: NCT03522246     History of Changes
Other Study ID Numbers: CO-338-087/GOG-3020/ENGOT-ov45
First Posted: May 11, 2018    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Clovis Oncology, Inc.:
ATHENA
Rucaparib
PARP inhibitor
PARPi
HRD
homologous recombination
DNA repair
LOH
DNA defect
DNA anomaly
Nivolumab
PD-1
Immuno-
oncology
Tumor
mutational
burden
BRCA

Additional relevant MeSH terms:
Rucaparib
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type
Fallopian Tube Diseases
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action