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A Phase 3 Study of Manganese-primed Immunochemotherapy in Patients With Advanced Ovarian Cancer
Sponsor: Chinese PLA General Hospital
Summary
Epithelial ovarian cancer is the most lethal gynecologic malignancy, and most patients eventually relapse and develop resistance to available therapies. Immune checkpoint inhibitors have shown limited overall efficacy in recurrent ovarian cancer, partly because of its immunosuppressive tumor microenvironment. Manganese (Mn2+) can activate the cGAS-STING pathway and may enhance antitumor immunity and the therapeutic effects of PD-1 blockade combined with chemotherapy. Following encouraging findings from an early-phase study, a randomized, single-blind, placebo-controlled phase II trial showed that the addition of manganese chloride to anti-PD-1 antibody, nab-paclitaxel, and cisplatin improved clinical outcomes compared with placebo, with an overall manageable safety profile. Based on these findings, this phase III trial is designed to confirm the efficacy and further evaluate the safety of Mn2+-primed immunochemotherapy in patients with advanced ovarian cancer.
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Manganese-primed Immunochemotherapy in Subjects With Advanced Ovarian Cancer
Key Details
Gender
FEMALE
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2026-10-12
Completion Date
2030-12-20
Last Updated
2026-09-16
Healthy Volunteers
No
Conditions
Interventions
Manganese Chloride
Administered by inhalation at 0.4mg/kg twice per week in the first 3-week cycle, and then inhaled 0.4mg/kg twice in the first week of each 3-week cycle thereafter
Nab-paclitaxel
Administered intravenously, 180-220mg/m2 on day 2 in a 3-week cycle (day 1 without Manganese priming)
Platinum chemotherapy
Administered intravenously, Cisplatin (60-80mg/m2) or Carboplatin (area under the curve \[AUC\] 4-6 mg/ mL per min) on day 2 in a 3-week cycle (day 1 without Manganese priming)
Anti-PD-1 antibody
Administered intravenously, 200mg on day 3 in a 3-week cycle (day 2 without Manganese priming)
Placebo
Administered by inhalation twice per week in the first 3-week cycle, and then inhaled twice in the first week of each 3-week cycle thereafter
Locations (6)
Department of Obstetrics and Gynecology, Seventh Medical Center, Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Department of Bio-therapeutic, First Medical Center, Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Department of Obstetrics and Gynecology, First Medical Center, Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Peking University International Hospital
Beijing, Beijing Municipality, China
Department of Obstetrics and Gynecology, North China University of Science and Technology Affiliated Hospital
Tangshan, Hebei, China
Department of Gynecologic Oncology, Shanxi Province Cancer Hospital
Taiyuan, Shanxi, China