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

Sponsor
Nykode Therapeutics ASA
Study ID
NCT04405349
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • VB10.16 — BIOLOGICAL
    Vaccination
  • Atezolizumab — BIOLOGICAL
    Intravenously infusion

Study Details

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.

Key Dates

Start date
Jul 1, 2020
Status verified
Dec 2023
Primary completion
Nov 24, 2023
Completion
Nov 24, 2023

Study Design

Enrollment
52 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Combination Therapy
    VB10.16 vaccinations. 11 intramuscular (i.m.) vaccinations for up to 48 weeks from first vaccination. 5 vaccinations of 3 mg VB10.16 during the first 12 weeks, followed by vaccination every 6 weeks for up to 48 weeks + Atezolizumab (1200 mg) intravenous (i.v.) infusion every 3 weeks.

Primary Outcome Measure

Incidence and severity of adverse events (AEs) [ Time Frame: 48 weeks (1 year follow-up) ]

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