NCT04834544

A Study of Maintenance DCVAC/OvCa After First-line Chemotherapy Added Standard of Care

A Randomized, Double-blind, Placebo-controlled, Preliminary Verifying Study About Safety and Efficacy of Maintenance DCVAC/OvCa After First-line Chemotherapy Added to Standard of Care in Patients With Newly Diagnosed FIGO III-IV Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, placebo-controlled,parallel-group preliminary verifying study about safety and efficacy of maintenance DCVAC/OvCa after first-line chemotherapy added to standard of care in patients with newly diagnosed FIGO III-IV ovarian, fallopian tube, or primary peritoneal carcinoma.

Conditions

• Epithelial Ovarian Carcinoma
• Fallopian Tube Carcinoma
• Primary Peritoneal Carcinoma

Interventions

Type	Name	Description
COMBINATION_PRODUCT	DCVAC/OvCa	An active cellular immunotherapy product containing autologous dendritic cells that are generated ex vivo from patient's monocytes and apoptotic tumor cells prepared from tumor cell lines
COMBINATION_PRODUCT	Placebo	Placebo

Timeline

• Start date: 2021-04-19
• Primary completion: 2024-10-20
• Completion: 2027-04-20
• First posted: 2021-04-08
• Last updated: 2021-05-03

Locations

1 site across 1 country: China