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

NCT06099418 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2024-09-20

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • GOG Foundation

    collaborator NETWORK

  • Nykode Therapeutics ASA

    lead INDUSTRY

Principal Investigators

  • Ritu Salani, MD MBA · UCLA Division of Gynecologic Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-18
Primary Completion
2027-05-31
Completion
2028-05-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06099418 on ClinicalTrials.gov