OncoMatch/Clinical Trials/NCT07822646
A Phase 3 Study of Manganese-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
Is NCT07822646 recruiting? Yes, currently enrolling (Oct 2026). This Phase 3 trial studies multiple treatments including Manganese Chloride and Nab-paclitaxel for ovarian cancer.
Treatment: Manganese Chloride · Nab-paclitaxel · Platinum chemotherapy · Anti-PD-1 antibody — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Other
Cancer type
Ovarian Cancer
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Must have received: systemic therapy
Patients who have received at least two prior lines of systemic therapy, including at least one platinum-based regimen. Patients who experienced disease progression during or within 6 months after completion of the most recent line of systemic therapy.
Must have received: platinum-based chemotherapy
including at least one platinum-based regimen
Lab requirements
Blood counts
ANC ≥ 1,000/mm³; Hemoglobin > 80 g/dL; Platelet count > 80,000/mm³; Peripheral blood white blood cell count > 3.5×10⁹/L
Kidney function
Serum creatinine < 3×ULN
Liver function
ALT/AST < 3×ULN; total bilirubin level < 3×ULN
Bone marrow reserve and liver and kidney function (the following laboratory tests should be performed before initial treatment to prove): Absolute neutrophil count (ANC) ≥ 1,000/mm³; Hemoglobin > 80 g/dL; Platelet count > 80,000/mm³; ALT/AST < 3×ULN; Serum creatinine < 3×ULN; Total bilirubin level < 3×ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07822646 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received systemic therapy and platinum-based chemotherapy.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages