C56
Conditions
Interventions
Group 1: • Intervention details: Patients with platinum-resistant epithelial ovarian cancer (EOC) undergo an in vitro diagnostic evaluation using the investigational VENTANA FOLR1 (FOLR1-2.1) IUO Assa
Sponsors
Ventana Medical Systems, Inc (Roche Tissue Diagnostics; RTD)
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: To be eligible for staining with the VENTANA FOLR1 (FOLR1-2.1) IUO Assay in this diagnostic study, a specimen must meet all the following criteria: 1. It must consist of archival or fresh biopsy EOC tumor tissue sample submitted to a Dx testing site for patient enrollment screening for Study D8991C00001; 2. It must consist of an FFPE tissue block or of at least 3 slides (5 preferred) containing serial sections cut from such a tissue block; 3. It must appear to contain sufficient good-quality tissue consistent with EOC (including primary peritoneal cancer and primary fallopian tube cancer) specimen for VENTANA FOLR1 (FOLR1-2.1) IUO Assay staining and interpretation, as determined by a Dx site pathologist’s review of a tissue section stained with H&E; and 4. Cut slides must be stained within 4 months of sectioning
Exclusion criteria
Exclusion criteria: Exclusion Criteria: A specimen will be excluded from the study if any of the following criteria are true: 1. It was fixed in alcohol-formalin-acetic acid (AFA), 95% alcohol, or any other alcohol-based fixative, zinc formalin, or PREFER™; or 2. It is a fine needle aspirate (FNA), any other cytological specimen (defined as a specimen lacking cellular context and tissue architecture); or 3. It consists of tissue containing bone that has been decalcified.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In the drug–companion diagnostic co-development model, the clinical performance of the companion diagnostic device is considered acceptable if the biomarker-associated pharmaceutical study efficacy endpoint(s) are met. Patient tumor specimen will be screened using the investigational VENTANA FOLR1 (FOLR1-2.1) IUO Assay to determine enrollment eligibility for Study D8991C00001. FOLR1 stained tumor specimen will be scored and a status assigned at the = 25%, = 50%, and = 75% cutoffs. Participants will be eligible for enrollment into Study D8991C00001 if their tumor specimen expresses = 25% of viable tumor cells with weak, moderate, and/or strong (= 1+) membrane staining intensity. Enrolled participants will be allocated into one of two study cohorts based on FOLR1 expression (low FOLR expression [FOLR1-Low], and high FOLR1 expression [FOLR1-High]). FOLR1-High expression cohort consists of patients whose tumor tissue express = 75% of viable tumor cells with moderate and/or strong (= 2+) membrane staining intensity. FOLR1-Low expression cohort consist of patients whose tumor tissue expresses =25% of viable tumor cells with = 1+ membrane staining intensity; but excludes patients whose tumor tissue have = 75% tumor cells with = 2+ membrane staining intensity. Patients allocated in the FOLR1-Low expression cohort are further stratified at the = 50% cutoff. Efficacy analyses will be performed on each of two study cohorts (FOLR1-Low and FOLR1-High) separately. Therefore, the following primary and key secondary endpoints described in Study D8991C00001 protocol will also serve as the primary endpoint for this diagnostic protocol (RD007436). In the FOLR1-High expression cohort: • Primary: Progression-free survival (PFS) of patients randomized to the AZD5335 vs. mirvetuximab soravtansine (MIRV) treatment arms. PFS assessed by investigator according to response evaluation criteria in solid tumors (Response Evaluation Criteria in Solid Tumors-RECIST 1.1). In the FOLR1-Low expressio | — |
Secondary
| Measure | Time frame |
|---|---|
| Additional Endpoints: Additional endpoints for this study include the following staining performance measures of the VENTANA FOLR1 (FOLR1-2.1) IUO Assay: • Initial and final staining acceptability rates for the assay at the patient level • Initial and final tissue morphology acceptability rates for the assay at the patient level • Initial background acceptability rates for the assay at the patient level There are no pre-determined acceptance criteria associated with these additional endpoints. | — |
Countries
Australia, Belgium, Brazil, Canada, Chile, China, Czechia, Denmark, France, Germany, Greece, India, Ireland, Israel, Italy, Japan, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, United States
Contacts
Public ContactKonstantinos Avraam
CellCarta NV
Outcome results
None listed