drugset
drugset / Trial / NCT03989336

A Study of the Pan-immunotherapy in Patients With Relapsed/Refractory Ovarian Cancer

NCT03989336 ↗

Phase 2 Completed 84 enrolled Chinese PLA General Hospital
RandomizedParallel-groupSingle-blindTreatment

Summary

Ovarian cancer is the most lethal gynecological cancer and the 5th leading cause of cancer death in women. Platinum chemotherapy has been widely adopted as a standard treatment for advanced ovarian cancer, the response rates in patients with relapsed/refractory ovarian cancer is unacceptably low. PD-1 blockade has been developed to a new class of cancer immunotherapy that could restore an adequate immunosurveillance against the neoplasm and enhance T-cell-mediated anticancer immune responses. Manganese has been confirmed to activate antigen-presenting cells and function as mucosal immunoadjuvants in pre-clinical studies. This two-arm, phase I/II study is designed to assess the safety and efficacy of combined therapy of anti-PD-1 antibody and chemotherapy with or without Manganese priming.

Timeline

Start
2020-12-23
Primary completion
2022-05-22
Completion
2023-12-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Manganese Chloride Other / unclassified 0.4 mg/kg Inhaled
Background Carboplatin Small molecule 4 mg/ml Intravenous
Background Carboplatin Small molecule 6 mg/ml Intravenous
Background Cisplatin Other / unclassified 60 mg/m2 Intravenous
Background Cisplatin Other / unclassified 80 mg/m2 Intravenous
Background Paclitaxel Small molecule 180 mg/m2 Intravenous
Background Paclitaxel Small molecule 220 mg/m2 Intravenous
Background Sintilimab Monoclonal antibody 200 mg Intravenous

Indications

ovarian cancer