At a glance
ClinicalIndex Comparison Record- ✓FIGO Stage III or IV high-grade serous ovarian cancer, primary peritoneal cancer, or fallopian tube cancer confirmed by histology
- ✓Candidate for carboplatin and paclitaxel chemotherapy in neoadjuvant and adjuvant setting
- ✓Candidate for interval debulking surgery
- ✓Able to provide archival tissue or newly obtained biopsy of tumor lesion
- ✕Non-high-grade serous ovarian cancer histology
- ✕History of non-infectious pneumonitis/interstitial lung disease requiring steroids or current pneumonitis/interstitial lung disease
- ✕Active malignancy or malignancy requiring treatment within past 3 years
- ✕Prior treatment for ovarian cancer including radiation or systemic anticancer therapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Phase 2 Study of Pembrolizumab And Chemotherapy With or Without MK-4830 as Neoadjuvant Treatment for High-Grade Serous Ovarian Cancer
In Brief
A Phase 2 clinical trial evaluating Pembrolizumab, Paclitaxel, and 4 other interventions for High-grade Serous Ovarian Carcinoma and Ovarian Carcinoma. Completed, enrolled 160 participants across 45 sites in 11 countries.
Detailed Summary
The primary objective is to evaluate in participants with high-grade serous ovarian cancer (HGSOC), whether the reduction from baseline in circulating tumor deoxyribonucleic acid (ctDNA) at Cycle 3 (ΔctDNA) is larger in participants receiving MK-4830 + pembrolizumab in combination with standard of care (SOC) therapy than in those receiving pembrolizumab + SOC therapy.
Study Details
Timeline
Interventions
200 mg by IV infusion on Day 1 of each 21-day cycle
175 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle
AUC 5 to 6 by IV infusion on Day 1 of each 21-day cycle
According to local practice and at the choice of the investigator.
800 mg by IV infusion on Day 1 of each 21-day cycle
75 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle