NCT06099418

Efficacy and Safety of VB10.16 Alone or in Combination With Atezolizumab in Patients With Advanced Cervical Cancer.

A Two-Arm Randomized, Double-Blind, Placebo-Controlled Phase 2 Selection Trial to Evaluate the Efficacy and Safety of VB10.16 Alone or in Combination With Atezolizumab in Patients With HPV16-Positive, PD-L1-positive, Recurrent or Metastatic Cervical Cancer Who Are Refractory to Pembrolizumab With Chemotherapy With/Without Bevacizumab.

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Nykode Therapeutics ASA · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center study in patients with recurrent or metastatic HPV16-positive, PD-L1 positive cervical cancer who has progressed during or after treatment with the first-line standard of care (pembrolizumab with chemotherapy with/without bevacizumab). The trial is designed to investigate VB10.16 alone or in combination with the immune checkpoint inhibitor, atezolizumab. The trial consist of 2 parts: the first part which investigates VB10.16 + placebo versus VB10.16 + atezolizumab. Approximately 30 patients will be included in each group. The goal of this part is to evaluate which of the two treatments is the best. The second part of the study will select the best treatment from part 1 and investigate the safety and efficacy of additional 70 patients.

Detailed description

This is a two-arm randomized, double-blind, placebo-controlled phase 2 selection trial to evaluate the efficacy and safety of VB10.16 alone or in combination with atezolizumab in patients with HPV16-positive, PD-L1-positive, recurrent or metastatic cervical cancer who are refractory to pembrolizumab with chemotherapy with/without bevacizumab. A selection design with a margin of practical equivalence will be implemented to monitor efficacy of the two experimental arms (VB10.16 + atezolizumab vs. VB10.16 + placebo). The trial consist of 2 parts: the first part which investigates VB10.16 + placebo versus VB10.16 + atezolizumab. Approximately 30 patients will be included in each group. The goal of this part is to evaluate which of the two treatments is the superior. The second part of the study will select the superior treatment from part 1 and investigate the safety and efficacy of additional 70 patients.

Conditions

• HPV-Related Cervical Carcinoma
• HPV-Related Malignancy
• Cervical Cancer

Interventions

Type	Name	Description
BIOLOGICAL	VB10.16	Intramuscular (i.m.) administrations of VB10.16 every 3 weeks (Q3W) during a 12-week induction period, followed by a maintenance period with administrations every 6 weeks (Q6W) from Week 13 until Week 49. A total of up to 11 i.m. administrations will be given. VB10.16 will be administered via Pharma Jet® Stratis 0.5 mL needle free injection system.
DRUG	Atezolizumab Injection [Tecentriq]	Intravenous (IV) infusions of atezolizumab (saline solution) every 3 weeks.
DRUG	Placebo	Intravenous (IV) infusions of placebo (saline solution) every 3 weeks.

Timeline

• Start date: 2024-04-18
• Primary completion: 2027-05-01
• Completion: 2028-05-01
• First posted: 2023-10-25
• Last updated: 2024-09-20

Regulatory

• FDA-regulated drug study