Study on Tuvusertib Combined with Niraparib or Lartesertib for Epithelial Ovarian Cancer
Sponsor: EMD Serono Research & Development Institute, Inc.
Sponsor score: 0
Inactive
ClinicalTrials ID:NCT06433219
This clinical trial is testing the safety and effectiveness of combining the drug tuvusertib with either niraparib or lartesertib in patients with epithelial ovarian cancer that has progressed after treatment with a PARP inhibitor.
Patient Parameters
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Program Overview
The aim of this study is to evaluate how well the combination of tuvusertib with either niraparib or lartesertib works in treating epithelial ovarian cancer. The study will focus on whether the cancer shrinks, disappears, stays the same, or worsens in patients who have previously been treated with a PARP inhibitor.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of high-grade serous or high-grade endometrioid ovarian, primary peritoneal, or fallopian tube cancer that has come back.
- Have a tumor with specific genetic mutations in BRCA1 or BRCA2 genes, or a positive HRD status, as determined by standard tests.
- Have cancer that has progressed while on PARP inhibitor therapy, either in the first or second-line maintenance setting, with specific conditions regarding previous treatments.
- Have measurable cancer according to standard criteria.
- Be in good overall health with an ECOG performance status of 0 or 1 and a life expectancy of at least 6 months.
- Other specific criteria as defined by the study protocol may apply.
Exclusion Criteria
- Have cancer that did not respond to initial platinum-based chemotherapy or progressed within 6 months after the last platinum treatment in the second-line setting.
- Have had another cancer within the last 3 years.
- Have known brain metastases unless they are stable and meet specific conditions.
- Have an active or uncontrolled infection.
- Have a known allergy to the study drugs or their ingredients.
- Have had an organ transplant, including stem cell transplant.
- Other specific criteria as defined by the study protocol may apply.
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