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

Cervical Cancer Clinical Trial

Official title:
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 Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06099418
Study type	Interventional
Source	Nykode Therapeutics ASA
Contact	Medical Lead Officer
Phone	+45 61303308
Email	roliveri@nykode.com
Status	Recruiting
Phase	Phase 2
Start date	April 18, 2024
Completion date	May 2028

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.