Gender
Female
Age Group
18 Years and up
Accepting Healthy Volunteers
No
Inclusion Criteria:
- Histologically or cytologically confirmed high grade serous or high grade
endometrioid ovarian, primary peritoneal, and/or fallopian tube cancer that is
recurrent.
- Participants whose tumor carries germline or somatic deleterious or suspected
deleterious mutations in the genes BRCA1 (Breast Cancer gene 1) and BRCA2 (Breast
Cancer gene 2), and/or tumors with positive HRD status. The presence of any of these
mutations and/or the homologous recombination deficiency (HRD) status will be
determined according to routinely used local standard of care tests. Results must be
available before screening.
- Radiologically confirmed/documented disease progression while on Poly (ADP-ribose)
polymerase (PARP) inhibitors therapy in either first or second-line maintenance
setting (only 1 line of PARPi maintenance is allowed with or without bevacizumab).
Note: Documentation of disease progression must be within 28 days of last PARPi dose
taken. Surgical salvage intervention and/or focal ablative therapies are allowed,
(further disease progression after these interventions must be documented), AND
Clinically benefited from PARPi maintenance prior to documented progression, as
defined by at least 6 months of treatment duration with no progressive disease
observed, AND either, Progression on first-line maintenance PARPi: Participants are
allowed maximum 1 additional line of platinum-based chemotherapy before study entry.
(note: treatment-free interval on platinum rechallenge must be >6 months, with
documented disease progression prior to study entry).
OR Progression on second-line maintenance PARPi: Participants are not allowed any
additional systemic anticancer treatments before study entry (that is PARPi is the last
treatment before study entry)
- Measurable disease per RECIST v1.1, as assessed by Investigator.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and a life
expectancy of at least 6 months.
- Other Protocol defined inclusion criteria could apply.
Exclusion Criteria:
- Primary platinum-refractory disease defined as disease progression during primary
platinum-based chemotherapy or platinum-resistant disease defined as disease
progression within 6 months of the last platinum administration in the second-line
setting.
- History of additional malignancy within 3 years before the date of enrollment.
- Known brain metastases, unless clinically stable, that is without evidence of
progression by imaging for at least 4 weeks prior to the first dose of study
intervention, no evidence of new brain metastases, and on a stable or decreasing
dose of ≤ 10 mg of prednisone (or equivalent) or without corticosteroids for at
least 14 days prior to study intervention administration.
- Active and/or uncontrolled infection.
- History of known hypersensitivity to the active substances or to any excipients
(e.g. polysorbate 80) of the study interventions.
- Organ transplantation, including allogenic stem cell transplant.
- Other Protocol defined exclusion criteria could apply.