Ignite Creation Date:
2024-05-06 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06016920
Status:
RECRUITING
Last Update Posted:
2024-04-11
First Post:
2023-08-24
Brief Title:
Safety and Efficacy of VB1016 and Pembrolizumab in Patients With Head-Neck Squamous Cell Carcinoma
Sponsor:
Nykode Therapeutics ASA
Organization:
Nykode Therapeutics ASA
Study Overview
Official Title:
A Phase 12a Open-label Dose-finding Trial to Evaluate Safety Immunogenicity and Anti-tumor Activity of VB1016 and Pembrolizumab in Patients With Unresectable Recurrent or Metastatic HPV16-positive Head-Neck Squamous Cell Carcinoma
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 VB1016 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 VB1016 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 VB1016 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 VB1016 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 VB1016 in combination with pembrolizumab for future clinical studies based on the safety tolerability and anti-tumor effect data generated
The trial is designed to define the optimal dose of VB1016 in combination with pembrolizumab for future clinical studies based on the safety tolerability and anti-tumor effect data generated
Detailed Description:
This phase 12a open-label dose-finding trial is designed to evaluate the safety tolerability immunogenicity and anti-tumor activity of VB1016 immunotherapy in patients with HPV16-positive RM oropharyngeal HNSCC whose tumors express PDL1 CPS 1 and who are eligible for pembrolizumab monotherapy as standard of care The trial is designed to determine the biological optimal dose BOD of VB1016 in combination with a fixed dose of pembrolizumab based on the totality of data ie safety tolerability anti-tumor activity and HPV16 E6E7specific cellular immune response The trial consists of 2 consecutive phases with separate patient groups in a seamless trial design a dose escalation phase phase 1 and a dose expansion phase phase 2a After completing 48 weeks of combination treatment patients can either continue pembrolizumab treatment with 200 mg Q3W administration or change to 400 mg Q6W administration at the discretion of the investigator and after consultation with the Sponsor
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-503055-26-00 | OTHER | None | None |
| KEYNOTE-E72 | OTHER | None | None |
| MK-3475-E72 | OTHER | Merck Sharp Dohme LLC | None |