NCT04405349

Investigating the Combination of VB10.16 and Atezolizumab in Patients With HPV 16-positive Cervical Cancer

A Multi-Centre, Open-label Phase 2a Trial of the Combination of VB10.16 and Atezolizumab in Patients With Advanced or Recurrent, Non-resectable HPV 16-Positive Cervical Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Nykode Therapeutics ASA · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase IIa study is designed to evaluate the safety and efficacy of multiple dosing with VB10.16 immunotherapy in combination with atezolizumab in patients with advanced or recurrent non-resectable HPV16-positive cervical cancer, who failed or are not eligible for current standard of care.

Detailed description

Patients will receive up to 11 intramuscular (i.m.) vaccinations of VB10.16, for up to 48 weeks from first vaccination. Patients will receive 5 vaccinations of 3 mg VB10.16 during the first 12 weeks, followed by vaccination every 6 weeks for up to 48 weeks from first immunisation (total of 11 vaccinations). Patients will receive up to 17 infusions of atezolizumab for up to 48 weeks from first treatment. Atezolizumab (1200 mg) will be administered as an intravenous (i.v.) infusion every 3 weeks. A follow-up period of up to 12 months will follow the 48 week treatment period. Response to the VB10.16 and atezolizumab combination will be assessed by computed tomography (CT)/magnetic resonance imaging (MRI) at every 9 weeks throughout the treatment period according to the RECIST 1.1 criteria.

Conditions

• Cervical Cancer
• Cervix Cancer

Interventions

Type	Name	Description
BIOLOGICAL	VB10.16	Vaccination
BIOLOGICAL	Atezolizumab	Intravenously infusion

Timeline

• Start date: 2020-07-01
• Primary completion: 2023-11-24
• Completion: 2023-11-24
• First posted: 2020-05-28
• Last updated: 2023-12-15

Locations

21 sites across 6 countries: Belgium, Bulgaria, Czechia, Germany, Norway, Poland