Description:
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.
Title
- Brief Title: A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy
- 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)
Clinical Trial IDs
- ORG STUDY ID:
CO-338-087/GOG-3020/ENGOT-ov45
- NCT ID:
NCT03522246
Conditions
- Epithelial Ovarian Cancer
- Primary Peritoneal
- Fallopian Tube Cancer
- Newly Diagnosed
- FIGO Stage III-IV
- Partial Response
- Complete Response
Interventions
Drug | Synonyms | Arms |
---|
Rucaparib | Rubraca, CO-338 | Arm A |
Nivolumab | Opdivo, BMS-936558 | Arm A |
Placebo Oral Tablet | | Arm C |
Placebo IV Infusion | | Arm B |
Purpose
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 Arms
Name | Type | Description | Interventions |
---|
Arm A | Experimental | oral rucaparib + intravenous (IV) nivolumab | |
Arm B | Experimental | oral rucaparib+IV placebo | - Rucaparib
- Placebo IV Infusion
|
Arm C | Experimental | oral placebo+ IV nivolumab | - Nivolumab
- Placebo Oral Tablet
|
Arm D | Placebo Comparator | Oral placebo + IV placebo | - Placebo Oral Tablet
- Placebo IV Infusion
|
Eligibility 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
- 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
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Female |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Investigator assessed Progression-free survival (PFS) |
Time Frame: | From randomization until disease progression (up to approximately 7 years) |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | 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 |
Safety Issue: | |
Description: | |
Measure: | Overall Survival (OS) |
Time Frame: | From enrollment to primary study completion of study (up to approximately 10 years) |
Safety Issue: | |
Description: | |
Measure: | 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 |
Safety Issue: | |
Description: | |
Measure: | 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 |
Safety Issue: | |
Description: | |
Measure: | 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) |
Safety Issue: | |
Description: | |
Measure: | 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) |
Safety Issue: | |
Description: | |
Measure: | 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) |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Clovis Oncology, Inc. |
Trial 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
- First-line
- Primary Therapy
- Primary Treatment
Last Updated
July 6, 2021