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

NCT04405349 | Completed Phase 2

• 1 other identifier: VB C-02
• Study Type: interventional
• Target: 52
• Locations: 6 countries
• Sites: 21

Brief Summary

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.

Conditions

Cervical Cancer; Cervix Cancer

Keywords

Metastatic; Recurrent

Outcome Measures

Primary Outcomes (2)

• Incidence and severity of adverse events (AEs)

  The number and percentage of participants that experience an adverse event (AE

  48 weeks (1 year follow-up)

• Overall response rate (ORR) using Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 at any time during the study

  ORR as assessed by RECIST v1.1

  48 weeks (1 year follow-up)

Secondary Outcomes (4)

• Duration of response (DOR)

  48 weeks (1 year follow-up)

• Progression-free survival (PFS)

  48 weeks (1 year follow-up)

• Overall survival (OS)

  48 weeks (1 year follow-up)

• Evaluate immunogenicity of VB10.16 in combination with atezolizumab by analysing HPV16 E6/E7-specific cellular immune responses

  48 weeks (1 year follow-up)

Other Outcomes (2)

• Assess predictive biomarkers, such as programmed death-ligand 1 (PD-L1) in tumour material and investigate changes in tumour microenvironment by immunohistochemistry (IHC) and/or gene expression

  48 weeks (1 year follow-up)

• Correlating HPV16 circulating tumour DNA (ctDNA) in plasma with clinical response using RECIST 1.1

  48 weeks (1 year follow-up)

Study Arms (1)

Combination Therapy

EXPERIMENTAL

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.

Biological: VB10.16; Biological: Atezolizumab

Interventions

VB10.16 BIOLOGICAL

Vaccination

Combination Therapy

Atezolizumab BIOLOGICAL

Intravenously infusion

Also known as: Tecentriq

Combination Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has persistent, recurrent, or metastatic non-resectable squamous cell carcinoma, adeno-squamous carcinoma, or adenocarcinoma of the cervix, who has failed or is not eligible for treatment with systemic chemotherapy, radiotherapy or other standard-of-care anticancer treatment.
• Tumour must be HPV16 positive. Provision of an archival tumour tissue sample not older than 2 years or new biopsy for analysing HPV16 status is mandatory.
• Must have a biopsy (archived or new) available for PD L1 assessment at Screening.
• Has measurable disease as assessed by the local site investigator/radiology as per RECIST 1.1.
• Has recovered from the effects of surgery, radiation therapy, or chemoradiotherapy.
• Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1 at Screening.
• Is aged 18 years or older.
• Has life expectancy of at least 6 months in the best judgement of the investigator.
• Is willing and able to sign a written informed consent form.

You may not qualify if:

• Patients who, in the investigator's opinion, have progressed rapidly on their previous anticancer treatment (e.g., did not achieve any response \[CR, PR, or SD\]).
• Has brain metastases (unless they have received prior treatment and are controlled and stable for at least 6 weeks before study enrolment) or leptomeningeal spread of disease.
• Has positive serological test for hepatitis C virus (HCV), hepatitis B virus (HBV), surface antigen (HBsAg), positive HBV core antibody. Human immunodeficiency virus (HIV).
• Has other concomitant or prior malignant disease,
• Has an active, known or suspected autoimmune disease.
• Is receiving systemic immunosuppression including systemic steroids or the use of immunosuppressive agents for any concurrent condition.
• Has known allergy to aminoglycosides or kanamycin or any study treatment component.
• Has history of toxic shock syndrome.
• Has history of idiopathic pulmonary fibrosis, drug-induced pneumonitis, organising pneumonia, immune enteritis or active pneumonitis.
• Has evidence or history of clinically significant cardiac disease including congestive heart failure
• Has ongoing toxicity from prior therapy
• Has severe infections within 4 weeks prior to study start
• Current participation in a clinical trial
• Has received investigational drug within 30 days before study entry.
• Has received vaccination against infections within 30 days before study entry.

Sponsors & Collaborators

• Nykode Therapeutics ASA: lead
• Roche Pharma AG: collaborator
• Vaccibody AS: collaborator

Study Sites (21)

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Hopital de Libramont

Brussels, 1200, Belgium

Location

Universitair Ziekenhuis Gent (Uz Gent)

Ghent, 9000, Belgium

Location

Chu Ucl Namur

Namur, 5000, Belgium

Location

Multiprofile Hospital for Active Treatment for Women's Health - Nadezhda Sofia

Sofia, 1330, Bulgaria

Location

University Multiprofile Hospital for Active Treatment "Sv. Ivan Rilski"

Sofia, 1431, Bulgaria

Location

Multiprofile Hospital for Active Treatment "Serdika"" EOOD

Sofia, 1527, Bulgaria

Location

University Multiprofile Hospital For Active Treatment Sofiamed

Sofia, 1797, Bulgaria

Location

Masaryk Memorial Cancer Institute

Brno, 65653, Czechia

Location

Nemocnice Pardubickeho Kraje Pardubicka Nemocnice

Pardubice, 53203, Czechia

Location

University Hospital Kralovske Vinohrady

Prague, 10034, Czechia

Location

Nemocnice Na Bulovce

Prague, 180 81, Czechia

Location

Universitatsklinikum Augsburg

Augsburg, Germany

Location

University Clinic Carl Gustav Carus

Dresden, Germany

Location

Universitatsklinikum Hamburg-Eppendorf

Hamburg, Germany

Location

Medizinische Hochschule Hannover

Hanover, Germany

Location

Medizinische Fakulat Mannheim Der Universitat Heidelberg

Heidelberg, Germany

Location

Oslo University Hospital

Oslo, 0379, Norway

Location

Jagielońskie Centum Innowacji, Centrum Badań Klinicznych JCI

Krakow, Poland

Location

Wielkopolskie Centrum Onkologii

Poznan, Poland

Location

'Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie

Warsaw, Poland

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Neoplasm Metastasis; Recurrence

Interventions

atezolizumab

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Siri Torhaug, MD

  Nykode Therapeutics ASA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: May 28, 2020
• Study Start: July 1, 2020
• Primary Completion: November 24, 2023
• Study Completion: November 24, 2023
• Last Updated: December 15, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (5); BU (4); NO (1); BE (4); PL (3); CZ (4)