Actively Recruiting
Safety and Efficacy of VB10.16 and Pembrolizumab in Patients with Head-Neck Squamous Cell Carcinoma
Led by Nykode Therapeutics ASA · Updated on 2024-12-17
51
Participants Needed
17
Research Sites
210 weeks
Total Duration
On this page
Sponsors
N
Nykode Therapeutics ASA
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a multi-center study in patients with un-resectable Recurrent or Metastatic HPV16-positive oropharyngeal Head and Neck Squamous Cell Carcinoma (HNSCC). The trial is designed to investigate VB10.16, an investigational therapeutic DNA vaccine in combination with another medicine, pembrolizumab, which is the standard of care for patients with previously untreated metastatic or resectable recurrent PD-L1 positive HNSCC. The study is divided in 2 parts: a phase 1, dose escalation part, testing 3 different doses of VB10.16 in combination with a standard fixed dose of pembrolizumab. The goal of this part is to evaluate the safety and tolerability of the combined treatment and to decide on the dose of VB10.16 to be used in the second part of the trial. In the second part of the trial, a phase 2a, dose expansion part, participants will receive either the highest safe dose of VB10.16 from part 1 or the 3 mg dose both in combination with pembrolizumab. The dose given to each participant will be decided in random. The trial is designed to define the optimal dose of VB10.16 in combination with pembrolizumab for future clinical studies based on the safety, tolerability and anti-tumor effect data generated.
CONDITIONS
Official Title
Safety and Efficacy of VB10.16 and Pembrolizumab in Patients with Head-Neck Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older at time of informed consent
- Histologically or cytologically confirmed recurrent/metastatic HNSCC in the oropharynx, not curable by local therapy and eligible for pembrolizumab monotherapy
- HPV16 positivity confirmed by central laboratory
- PD-L1 positivity with CPS 21 using validated assay
- At least one measurable lesion according to RECIST 1.1
- ECOG performance status of 0 or 1
- Adequate hematological function: platelets 2100 x 10^9/L, neutrophils 21.5 x 10^9/L, hemoglobin 25.6 mmol/L
- Adequate liver function: bilirubin, AST, ALT, alkaline phosphatase within specified limits
- Adequate kidney function: estimated glomerular filtration rate 245 mL/min/1.73 m^2
- Female patients of childbearing potential must have a negative pregnancy test and agree to use effective contraception
- Male patients must agree to use condoms during intercourse and avoid sperm donation during and after treatment
- Ability to provide signed informed consent
You will not qualify if you...
- Disease suitable for curative local therapy
- Progression within 6 months after curative chemoradiotherapy
- Primary tumor in oral cavity, hypopharynx, larynx, or nasopharynx
- Rapidly progressing disease or uncontrolled symptoms
- Prior palliative radiotherapy within 2 weeks or history of radiation pneumonitis
- Previous systemic antineoplastic or investigational therapy in the recurrent/metastatic setting
- Prior organ or stem cell transplantation (except corneal)
- Previous CAR-T cell therapy or HPV16 therapeutic vaccine
- Use of systemic immunosuppressive agents or corticosteroids exceeding 10 mg prednisone daily
- Recent use of certain blood products or growth factors
- Prior therapy with anti-PD-1, anti-PD-L1, or similar agents
- Recent surgery or planned major surgery
- Other malignancies not adequately treated or at high risk of recurrence
- Bleeding disorders or significant cardiovascular disease
- History or active pneumonitis/interstitial lung disease
- Immunodeficiency or active autoimmune disease requiring recent systemic therapy
- Known HIV, active Hepatitis B or C infections
- Active infections requiring systemic treatment
- Known allergies to study drugs or excipients
- Active central nervous system metastases or recent symptomatic brain metastases
- Participation in other investigational trials in the recurrent/metastatic setting
- Psychiatric or substance abuse disorders interfering with participation
- Use of therapeutic anticoagulants contraindicating study treatments
- Pregnant or breastfeeding females
AI-Screening
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Trial Site Locations
Total: 17 locations
1
Fakultni nemocnice Olomouc, Olomuoc
Olomouc, Czechia
Actively Recruiting
2
Hôpital de la Pitié - Salpétrière in Paris
Paris, Paris, France, 75013
Actively Recruiting
3
Hospices Civils De Lyon
Lyon, France
Actively Recruiting
4
CRLC Val d'Aurelle - Institut de Recherche en Cancerologie de Montpellier (IRCM)
Montpellier, France, 34298
Actively Recruiting
5
Institut Gustave Roussy, Paris
Paris, France
Actively Recruiting
6
Universität Leipzig Klinik und Poliklinik für Hals-, Nasen-, Ohrenheilkunde
Leipzig, Germany
Actively Recruiting
7
Orszagos Onkologiai Intezet, Budapest
Budapest, Hungary
Actively Recruiting
8
University of Bergen, Haukeland University Hospital
Bergen, Norway
Actively Recruiting
9
Oslo Universitetssykehus
Oslo, Norway
Actively Recruiting
10
Uniwersyteckie Cetrum Kliniczne
Gdansk, Poland
Actively Recruiting
11
Narodowy Instytut Onkologii-im Marii Sklodowskiej-Curie Panstwowy Instytut
Gliwice, Poland
Actively Recruiting
12
KO-MED Centra Kliniczne Lublin II, Lublin
Lublin, Poland
Actively Recruiting
13
Hospital del Mar, Barcelona
Barcelona, Spain
Actively Recruiting
14
Institut Catala d'Oncologia, Barcelona
Barcelona, Spain
Actively Recruiting
15
Hospital Universitario Virgen de las Nieves, Granada
Granada, Spain
Actively Recruiting
16
MD Anderson Cancer Center, Madrid
Madrid, Spain
Actively Recruiting
17
East and North Hertfordshire NHS Trust Mount Vernon Hospital
London, United Kingdom
Actively Recruiting
Research Team
C
Chief Medical Officer
CONTACT
S
Senior Clinical Trial Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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