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

Active:	No
Cancer Type:	Cervical Cancer Unknown Primary	NCT ID:	NCT06099418
Trial Phases:	Phase II	Protocol IDs:	VB-C-04 (primary) NCI-2024-00299 GOG-3091
Eligibility:	18 Years and older, Female	Study Type:	Treatment
Study Sponsor:	Nykode Therapeutics ASA
NCI Full Details:	http://clinicaltrials.gov/show/NCT06099418

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.

Objectives

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.