NCT03905902

DCVAC/OvCa and Standard of Care (SoC) in Relapsed Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma

A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of DCVAC/OvCa Added to Standard of Care in Patients With Relapsed Platinum-sensitive Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: SOTIO a.s. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Multi-center, phase III trial of DCVAC/OvCa added to standard of care treatments for relapsed ovarian cancer. Patients will receive study treatment until all doses are administered, or other criteria are met.

Detailed description

All patients who meet entry criteria will be randomized, and will undergo a leukapheresis procedure. During the Induction period, all patients will receive DCVAC/OvCa or placebo (study treatment) with concurrent standard-of-care platinum-based chemotherapy, with or without use of bevacizumab. In the Maintenance period, patients will continue treatment with study treatment in combination with bevacizumab, a poly (ADP-ribose) polymerase inhibitor (PARPi) or best supportive care only. Study treatment will continue irrespective of disease progression

Conditions

• Ovarian Cancer
• Fallopian Tube Cancer
• Peritoneal Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	DCVAC/OvCa	activated autologous dendritic cells
BIOLOGICAL	DCVAC/OvCa placebo	placebo for activated autologous cells

Timeline

• Start date: 2021-08-01
• Primary completion: 2021-08-01
• Completion: 2021-08-16
• First posted: 2019-04-08
• Last updated: 2021-12-23