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

NCT ID: NCT04405349

Last Updated: 2023-12-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2023-11-24

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.

Detailed Description

Patients will receive up to 11 intramuscular (i.m.) vaccinations of VB10.16, for up to 48 weeks from first vaccination. Patients will receive 5 vaccinations of 3 mg VB10.16 during the first 12 weeks, followed by vaccination every 6 weeks for up to 48 weeks from first immunisation (total of 11 vaccinations). Patients will receive up to 17 infusions of atezolizumab for up to 48 weeks from first treatment. Atezolizumab (1200 mg) will be administered as an intravenous (i.v.) infusion every 3 weeks. A follow-up period of up to 12 months will follow the 48 week treatment period.

Response to the VB10.16 and atezolizumab combination will be assessed by computed tomography (CT)/magnetic resonance imaging (MRI) at every 9 weeks throughout the treatment period according to the RECIST 1.1 criteria.

Conditions

Cervical Cancer; Cervix Cancer

Keywords

Metastatic; Recurrent

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

VB10.16

Intervention Type: BIOLOGICAL

Vaccination

Atezolizumab

Intervention Type: BIOLOGICAL

Intravenously infusion

Interventions

VB10.16

Vaccination

Intervention Type: BIOLOGICAL

Atezolizumab

Intravenously infusion

Intervention Type: BIOLOGICAL

Other Intervention Names

Tecentriq

Eligibility Criteria

Inclusion Criteria

1. 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.

2. 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.

3. Must have a biopsy (archived or new) available for PD L1 assessment at Screening.

4. Has measurable disease as assessed by the local site investigator/radiology as per RECIST 1.1.

5. Has recovered from the effects of surgery, radiation therapy, or chemoradiotherapy.

6. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1 at Screening.

7. Is aged 18 years or older.

8. Has life expectancy of at least 6 months in the best judgement of the investigator.

9. Is willing and able to sign a written informed consent form.

Exclusion Criteria

1. 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]).

2. 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.

3. Has positive serological test for hepatitis C virus (HCV), hepatitis B virus (HBV), surface antigen (HBsAg), positive HBV core antibody. Human immunodeficiency virus (HIV).

4. Has other concomitant or prior malignant disease,

5. Has an active, known or suspected autoimmune disease.

6. Is receiving systemic immunosuppression including systemic steroids or the use of immunosuppressive agents for any concurrent condition.

7. Has known allergy to aminoglycosides or kanamycin or any study treatment component.

8. Has history of toxic shock syndrome.

9. Has history of idiopathic pulmonary fibrosis, drug-induced pneumonitis, organising pneumonia, immune enteritis or active pneumonitis.

10. Has evidence or history of clinically significant cardiac disease including congestive heart failure

11. Has ongoing toxicity from prior therapy

12. Has severe infections within 4 weeks prior to study start

13. Current participation in a clinical trial

14. Has received investigational drug within 30 days before study entry.

15. Has received vaccination against infections within 30 days before study entry.

16. Has had prior treatment with CD137, anti-PD-1, or anti-PD-L1 therapeutic antibody or other immune checkpoint targeting agents.

17. Has known hypersensitivity to any component of the atezolizumab or VB10.16 formulation.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Roche Pharma AG

INDUSTRY

Sponsor Role: collaborator

Vaccibody AS

INDUSTRY

Sponsor Role: collaborator

Nykode Therapeutics ASA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Siri Torhaug, MD

Role: STUDY_DIRECTOR

Nykode Therapeutics ASA

Locations

Cliniques Universitaires Saint-Luc

Brussels, , Belgium

Hopital de Libramont

Brussels, , Belgium

Universitair Ziekenhuis Gent (Uz Gent)

Ghent, , Belgium

Chu Ucl Namur

Namur, , Belgium

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

Sofia, , Bulgaria

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

Sofia, , Bulgaria

Multiprofile Hospital for Active Treatment "Serdika"" EOOD

Sofia, , Bulgaria

University Multiprofile Hospital For Active Treatment Sofiamed

Sofia, , Bulgaria

Masaryk Memorial Cancer Institute

Brno, , Czechia

Nemocnice Pardubickeho Kraje Pardubicka Nemocnice

Pardubice, , Czechia

University Hospital Kralovske Vinohrady

Prague, , Czechia

Nemocnice Na Bulovce

Prague, , Czechia

Universitatsklinikum Augsburg

Augsburg, , Germany

University Clinic Carl Gustav Carus

Dresden, , Germany

Universitatsklinikum Hamburg-Eppendorf

Hamburg, , Germany

Medizinische Hochschule Hannover

Hanover, , Germany

Medizinische Fakulat Mannheim Der Universitat Heidelberg

Heidelberg, , Germany

Oslo University Hospital

Oslo, , Norway

Jagielońskie Centum Innowacji, Centrum Badań Klinicznych JCI

Krakow, , Poland

Wielkopolskie Centrum Onkologii

Poznan, , Poland

'Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie

Warsaw, , Poland

Countries

Belgium; Bulgaria; Czechia; Germany; Norway; Poland

Other Identifiers

VB C-02

Identifier Type: -

Identifier Source: org_study_id