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)

Conditions

Ovarian epithelial cancer, advanced (FIGO stage III-IV), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer (who responded to front-line platinum-based chemotherapy), Fallopian tube cancer, Malignant peritoneal neoplasm

Brief summary

The primary efficacy endpoint for the study is investigator-determined progression-free survival (PFS) by RECIST v1.1. Investigator-determined PFS is defined as the time from randomization to disease progression, according to RECIST v1.1 criteria as assessed by the investigator, or death due to any cause, whichever occurs first.

Detailed description

Secondary Efficacy Endpoints: Progression-free survival (PFS) as assessed by blinded independent central review (BICR) by RECIST will be tested as a stand-alone secondary endpoint, outside of the step-down procedure for multiplicity adjustment, due to it being supportive of the primary endpoint., BicrPFS is defined as the time from randomization to disease progression, according to RECIST v1.1 criteria as assessed by BICR, or death due to any cause, whichever occurs first. Only tumor scans prior to start of any subsequent anti-cancer treatment are included. Overall survival is defined as the time from randomization to death due to any cause., Analyses of objective response rate (ORR) will be performed in the subgroup of patients with measurable disease at baseline and will be summarized with frequencies and percentages. Duration of response (DOR) will be tested as a stand-alone secondary endpoint, outside of the step-down procedure for multiplicity adjustment., DOR is defined as the interval from the first documentation of objective response (RECIST v1.1) to the earlier of the first documentation of disease progression (per RECIST v1.1) or death from any cause. Safety Analysis: Adverse events, clinical laboratory results, vital signs, ECOG performance status, body weight, and concomitant medications/procedures.

Related papers

No related papers found yet.

Papers published before 2008-02-04 may not appear yet. Historical indexing is in progress.

Interventions

DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.

DRUGPlacebo for Rubraca

DRUGPlacebo for Opdivo

DRUGRubraca 250 mg film-coated tablets

DRUGRubraca 200 mg film-coated tablets

DRUGRubraca 300 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary efficacy endpoint for the study is investigator-determined progression-free survival (PFS) by RECIST v1.1. Investigator-determined PFS is defined as the time from randomization to disease progression, according to RECIST v1.1 criteria as assessed by the investigator, or death due to any cause, whichever occurs first.	—

Secondary

Measure	Time frame
Secondary Efficacy Endpoints: Progression-free survival (PFS) as assessed by blinded independent central review (BICR) by RECIST will be tested as a stand-alone secondary endpoint, outside of the step-down procedure for multiplicity adjustment, due to it being supportive of the primary endpoint., BicrPFS is defined as the time from randomization to disease progression, according to RECIST v1.1 criteria as assessed by BICR, or death due to any cause, whichever occurs first. Only tumor scans prior to start of any subsequent anti-cancer treatment are included. Overall survival is defined as the time from randomization to death due to any cause., Analyses of objective response rate (ORR) will be performed in the subgroup of patients with measurable disease at baseline and will be summarized with frequencies and percentages. Duration of response (DOR) will be tested as a stand-alone secondary endpoint, outside of the step-down procedure for multiplicity adjustment., DOR is defined as the in	—

Measure

Time frame

Secondary Efficacy Endpoints: Progression-free survival (PFS) as assessed by blinded independent central review (BICR) by RECIST will be tested as a stand-alone secondary endpoint, outside of the step-down procedure for multiplicity adjustment, due to it being supportive of the primary endpoint., BicrPFS is defined as the time from randomization to disease progression, according to RECIST v1.1 criteria as assessed by BICR, or death due to any cause, whichever occurs first. Only tumor scans prior to start of any subsequent anti-cancer treatment are included. Overall survival is defined as the time from randomization to death due to any cause., Analyses of objective response rate (ORR) will be performed in the subgroup of patients with measurable disease at baseline and will be summarized with frequencies and percentages. Duration of response (DOR) will be tested as a stand-alone secondary endpoint, outside of the step-down procedure for multiplicity adjustment., DOR is defined as the in

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Countries

Belgium, Czechia, Denmark, Germany, Greece, Ireland, Italy, Poland, Romania, Spain, Sweden

Outcome results

None listed