History of Changes for Study: NCT03522246

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

A study version is represented by a row in the table.
Select two study versions to compare. One each from columns A and B.
Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
Click "Compare" to do the comparison and show the differences.
Select a version's Submitted Date link to see a rendering of the study for that version.
The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
Hover over the "Recruitment Status" to see how the study's recruitment status changed.
Study edits or deletions are displayed in red.
Study additions are displayed in green.

Study Record Versions

Version	Submitted Date	Changes
1	April 30, 2018	None (earliest Version on record)
2	June 26, 2018	Recruitment Status, Study Status, Contacts/Locations, Outcome Measures and Oversight
3	October 9, 2018	Contacts/Locations, Study Status and Conditions
4	November 6, 2018	Study Status and Contacts/Locations
5	December 20, 2018	Study Status and Contacts/Locations
6	February 5, 2019	Study Status and Contacts/Locations
7	March 1, 2019	Study Status and Contacts/Locations
8	April 11, 2019	Study Status and Contacts/Locations
9	April 15, 2019	Contacts/Locations and Study Status
10	April 29, 2019	Contacts/Locations and Study Status
11	July 31, 2019	Study Status and Contacts/Locations
12	October 29, 2020	Recruitment Status, Contacts/Locations, Study Status, Eligibility and Study Design
13	July 2, 2021	Contacts/Locations and Study Status
14	November 3, 2021	Study Status and Contacts/Locations
15	February 17, 2023	Study Status and Contacts/Locations
16	June 7, 2023	Sponsor/Collaborators, Study Status and Study Identification
17	June 12, 2023	Study Status and Study Identification
18	September 14, 2023	Study Status and Contacts/Locations

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	CO-338-087/GOG-3020/ENGOT-ov45
Brief Title:	A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy (ATHENA)
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)
Secondary IDs:

Study Status


Record Verification:	April 2018
Overall Status:	Not yet recruiting
Study Start:	April 30, 2018
Primary Completion:	December 30, 2024 [Anticipated]
Study Completion:	December 30, 2030 [Anticipated]

First Submitted:	April 9, 2018
First Submitted that Met QC Criteria:	April 30, 2018
First Posted:	May 11, 2018 [Actual]

Last Update Submitted that Met QC Criteria:	April 30, 2018
Last Update Posted:	May 11, 2018 [Actual]

Sponsor/Collaborators


Sponsor:	Clovis Oncology, Inc.
Responsible Party:	Sponsor
Collaborators:	Bristol-Myers Squibb Gynecologic Oncology Group European Network of Gynaecological Oncological Trial Groups (ENGOT) Foundation Medicine

Oversight


U.S. FDA-regulated Drug:	Yes
U.S. FDA-regulated Device:	No
Data Monitoring:	Yes

Study Description


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:

Conditions


Conditions:	Epithelial Ovarian Cancer Primary Peritoneal Fallopian Tube Cancer Newly Diagnosed FIGO Stage III-IV Partial Response Complete Response
Keywords:	PARP inhibitor PARPi HRD ATHENA homologous recombination DNA repair LOH DNA defect DNA anomaly Rucaparib Nivolumab PD-1 Immuno- oncology Tumor mutational burden BRCA

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 3
Interventional Study Model:	Parallel Assignment
Number of Arms:	4
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:	Randomized
Enrollment:	1012 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
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

Outcome Measures


Primary Outcome Measures:
1.	Investigator assessed Progression-free survival (PFS) [ Time Frame: From randomization until disease progression (up to approximately 10 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) ]

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	Female
Gender Based:
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

Contacts/Locations


Central Contact Person:	Clovis Oncology Clinical Trial Information Telephone: 1-855-262-3040 (USA) Email: clovistrials@emergingmed.com
Central Contact Backup:	Clovis Oncology Clinical Trial infomration Telephone: +1-303-625-5160 (ex-USA) Email: clovistrials@emergingmed.com
Locations:	United States, Arizona
	Arizona Oncology (US Oncology Network) Phoenix, Arizona, United States, 85016 Contact:Contact: Bradley Monk, MD, FACS, FACOG
	United Kingdom
	University College London London, United Kingdom, WCIE 6DD Contact:Contact: Rebecca Kristeleit, Msc, MBChB, FRCP, PhD

IPDSharing


Plan to Share IPD:

References


Links:
Available IPD/Information: