Clinical Studies Search

Protocol Summary


Protocol No.
PSCI-18-103
Prinicipal Investigator
Kesterson, Joshua
Phase
Phase III
Age Group
Adult
Scope
National
Secondary Protocol No.
CO-338-087 ATHENA (GOG 3020)
Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Rucaparib in combination with Nivolumab versus Placebo as Switch Maintenance Following Response to Front-Line Platinum-Based Chemotherapy in Patients with High-Grade Serous or Endometrioid Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer
Objective
Primary Objective:

To evaluate PFS by Response Evaluation Criteria in Solid Tumors (RECIST), as assessed by the investigator, in molecularly-defined HRD subgroups, using the following parallel comparisons:
-Arm A (oral rucaparib+ intravenous [IV] nivolumab) versus Arm B (oral rucaparib + IV placebo)
-Arm A (oral rucaparib+IV nivolumab) versus Arm D (placebo [oral and IV])
-Arm B (oral rucaparib+IV placebo) versus Arm D (placebo [oral and IV])

Secondary Objectives:

To evaluate PFS by RECIST, as assessed by the blinded independent central
review (BICR), in molecularly-defined HRD subgroups
To evaluate survival benefit
To evaluate the objective response rate (ORR) and duration of response (DOR), as assessed by the investigator, in patients with measurable disease at baseline
To evaluate safety

Exploratory Objectives:

To evaluate PFS2 (PFS on the subsequent line of treatment)
To evaluate the contribution of nivolumab (Arm C) in the combination therapy
To evaluate Health-related Quality of Life (HRQoL) as assessed by the trial
outcome index (TOI) of the Functional Assessment of Cancer Therapy - Ovarian (FACT-O)
To evaluate patient-reported outcome (PRO) utilizing the Euro-Quality of Life 5D (EQ-5D)
To assess mutations in non-tumor BRCA (where tBRCA defines a tumor tissue
alteration in BRCA1 or BRCA2) homologous recombination repair (HRR) genes as a molecular marker of efficacy
To assess PD-L1 expression and TMB as molecular markers of efficacy
To study variants in circulating tumor DNA (ctDNA) as markers of response and resistance
To characterize pharmacokinetics (PK) of rucaparib as monotherapy and in
combination with nivolumab
To characterize PK of nivolumab as a monotherapy and in combination with rucaparib
To evaluate immunogenicity of nivolumab when administered as a monotherapy and in combination with rucaparib
To explore exposure-response relationship between selected exposure measures of rucaparib and nivolumab, and safety and efficacy endpoints
Applicable Disease Sites
Other Female Genital

Ovary
Status
Open
Participating Institutions
Hershey Medical Center