Comparing 3 approaches for epithelial ovarian cancer

Inclusion

• +Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
• +Participants are eligible to be included in the study only if all the following criteria apply:
• +Females ≥18 years of age (or the legal age of consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → in the jurisdiction in which the study is taking place) at the time of signing the informed consent.
• +Participants must sign the informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocolProtocolThe detailed plan a study must follow.Read more →.
• +Disease Type:
• +Histologically or cytologically confirmed diagnosis of advanced (unresectable) or metastatic high grade serous ovarian, primary peritoneal (i.e, of primary origin), or fallopian tube cancer. High-grade endometrioid ovarian cancer is permitted for enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →.
• +Participant's tumor must be positive for CLDN6 expression as defined by the CLDN6 reference laboratory assay. Tumor tissue will be required for submission for CLDN6 testing prior to Cycle 1 Day 1.
• +Participants must have platinum-resistant disease, defined as the following:
• +If participants received only 1 line of platinum-based therapy, they must have completed 4 or more cycles of platinum-containing therapy, must have achieved a CR or PR, and progressed \>3 months but ≤6 months after the last dose of platinum.
• +Participants who have received more than 1 line of platinum- based therapy must have progressed on or within 6 months after the last dose of platinum.
• +NOTE: This should be calculated from the date of the last administered dose of platinum therapy to the date of the radiographic imaging showing progression (per RECIST v1.1).
• +Participants who are platinum-refractory during front-line treatment are excluded.
• +Participants must have received at least 1 but no more than 3 prior systemic lines of anticancer therapy, and for whom single- agent therapy is appropriate as the next line of treatment. Study rules for evaluation of number of prior systemic lines of therapy:
• +Adjuvant ± neoadjuvant is considered one line of therapy
• +Maintenance therapy (eg, bevacizumab or PARP inhibitors) will be considered part of the preceding line of therapy (ie, not counted independently)
• +Therapy changed due to toxicity in the absence of progression will be considered part of the same line (ie, not counted independently)
• +Hormonal therapy will not be counted as a separate line of therapy
• +Measurable disease, per RECIST v1.1
• +Adequate organ function, based on the following laboratory values:
• +ANC: ≥1,500/mcL
• +Platelets: ≥100,000/mcL without transfusion within 4 weeks of first dose
• +Hemoglobin: 9 g/dL with transfusion or EPO support up to 14 days before eligibilityEligibility criteriaThe full list of requirements for taking part in a study.Read more → assessment
• +Measured or calculated creatinine clearance with a validated formula\*: ≥30 mL/min
• +Serum total bilirubin: ≤1.5 X ULN (participants with known Gilbert disease or liver metastases who have serum bilirubin level ≤3×ULN may be enrolled
• +AST (SGOT) and ALT (SGPT): ≤3 X ULN (participants with active liver metastases who have ALT/AST ≤5 X ULN may be enrolled)
• +Albumin: ≥2.5 g/dL
• +ECG: 12-Lead ECG with normal tracing or non-clinically significant changes that do not require medical intervention and QTcF interval
• +470 msec and without history of Torsades des Pointes or other symptomatic QTc abnormality.
• +Participants must agree to use a highly effective birth controlControl groupThe group a new treatment is measured against.Read more → method from the time of the first study drug treatment through 7 months after the last study drug treatment, or be of nonchildbearing potential.
• +Participants must agree not to donate eggs from the first study drug treatment through 7 months after the last study drug treatment.
• +Participants of childbearing potential must have a negative serum pregnancy test within 72 hours before starting study drug treatment. The serum pregnancy test must be negative for the participant to be eligible.
• +Participants must agree to not breastfeed from the first dose of study treatment through 90 days after the last dose of study treatment.