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| Name | Class |
|---|---|
| Roche Pharma AG | INDUSTRY |
| Vaccibody AS | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VB10.16 | Biological | Vaccination |
| |
| Atezolizumab |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of response (DOR) | Estimate the duration of response (DOR) in patients with advanced cervical cancer | 48 weeks (1 year follow-up) |
| Progression-free survival (PFS) | Estimate the Progression-free survival (PFS) in patients with advanced cervical cancer |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | T cell infiltration, PD-L1 expression or other immune-oncology related genes | 48 weeks (1 year follow-up) |
| Correlating HPV16 circulating tumour DNA (ctDNA) in plasma with clinical response using RECIST 1.1 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Siri Torhaug, MD | Nykode Therapeutics ASA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliniques Universitaires Saint-Luc | Brussels | 1200 | Belgium | |||
| Hopital de Libramont |
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| Biological |
Intravenously infusion |
|
|
| 48 weeks (1 year follow-up) |
| Overall survival (OS) | Overall survival (OS) in patients with advanced cervical cancer | 48 weeks (1 year follow-up) |
| Evaluate immunogenicity of VB10.16 in combination with atezolizumab by analysing HPV16 E6/E7-specific cellular immune responses | Systemic T-cell response | 48 weeks (1 year follow-up) |
ctDNA |
| 48 weeks (1 year follow-up) |
| Brussels |
| 1200 |
| Belgium |
| Universitair Ziekenhuis Gent (Uz Gent) | Ghent | 9000 | Belgium |
| Chu Ucl Namur | Namur | 5000 | Belgium |
| Multiprofile Hospital for Active Treatment for Women's Health - Nadezhda Sofia | Sofia | 1330 | Bulgaria |
| University Multiprofile Hospital for Active Treatment "Sv. Ivan Rilski" | Sofia | 1431 | Bulgaria |
| Multiprofile Hospital for Active Treatment "Serdika"" EOOD | Sofia | 1527 | Bulgaria |
| University Multiprofile Hospital For Active Treatment Sofiamed | Sofia | 1797 | Bulgaria |
| Masaryk Memorial Cancer Institute | Brno | 65653 | Czechia |
| Nemocnice Pardubickeho Kraje Pardubicka Nemocnice | Pardubice | 53203 | Czechia |
| University Hospital Kralovske Vinohrady | Prague | 10034 | Czechia |
| Nemocnice Na Bulovce | Prague | 180 81 | 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 | 0379 | Norway |
| Jagielońskie Centum Innowacji, Centrum Badań Klinicznych JCI | Krakow | Poland |
| Wielkopolskie Centrum Onkologii | Poznan | Poland |
| 'Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie | Warsaw | Poland |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D009362 | Neoplasm Metastasis |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
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| ID | Term |
|---|---|
| C000594389 | atezolizumab |
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