NCT03989336

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

A Randomized, Single-blind, Placebo-controlled, Phase 2 Study to Evaluate the Safety and Efficacy of the Pan-immunotherapy in Subjects With Relapsed/Refractory Ovarian Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	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
DRUG	nab-paclitaxel	Administered intravenously, 180-220mg/m2 on day 2 in a 3-week cycle (day 1 without Manganese priming)
DRUG	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)
DRUG	Sintilimab	Administered intravenously, 200mg on day 3 in a 3-week cycle (day 2 without Manganese priming)

Timeline

• Start date: 2020-12-23
• Primary completion: 2022-05-22
• Completion: 2023-12-10
• First posted: 2019-06-18
• Last updated: 2024-07-15

Locations

1 site across 1 country: China