Clinical Trials Logo

Clinical Trial Summary

This is a multi-center study in patients with un-resectable Recurrent or Metastatic HPV16-positive 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.


Clinical Trial Description

This phase 1/2a, open-label, dose-finding trial is designed to evaluate the safety, tolerability, immunogenicity, and anti-tumor activity of VB10.16 immunotherapy in patients with HPV16-positive R/M 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 VB10.16 in combination with a fixed dose of pembrolizumab based on the totality of data (i.e., safety, tolerability, anti-tumor activity, and HPV16 E6/E7specific 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 Design


Related Conditions & MeSH terms


NCT number NCT06016920
Study type Interventional
Source Nykode Therapeutics ASA
Contact Chief Medical Officer
Phone +47 951 133 93
Email storhaug@nykode.com
Status Recruiting
Phase Phase 1/Phase 2
Start date December 19, 2023
Completion date January 2028

See also
  Status Clinical Trial Phase
Recruiting NCT06016699 - Immunological Function After Radiation With Either Proton or Photon Therapy
Recruiting NCT04370587 - A Clinical Study of Intratumoral MVR-T3011 (T3011) Given as a Single Agent and in Combination With Intravenous Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Recruiting NCT04114136 - Anti-PD-1 mAb Plus Metabolic Modulator in Solid Tumor Malignancies Phase 2
Active, not recruiting NCT02999087 - Randomized Trial of Avelumab-cetuximab-radiotherapy Versus SOCs in LA SCCHN (REACH) Phase 3
Recruiting NCT05877430 - Safety, Tolerability, and Preliminary Efficacy of CJRB-101 With Pembrolizumab in Subjects With Selected Types of Advanced or Metastatic Cancer Phase 1/Phase 2
Completed NCT06446570 - Phase II Study of Durvalumab(MEDI4736) + Tremelimumab in Pulmonary Sarcomatoid Carcinoma Phase 2
Completed NCT03292250 - Korean Cancer Study Group: Translational bIomarker Driven UMbrella Project for Head and Neck (TRIUMPH), Esophageal Squamous Cell Carcinoma- Part 1 (HNSCC)] Phase 2
Recruiting NCT05980000 - Ramucirumab and Pembrolizumab vs Pembrolizumab Monotherapy in PD-L1 Positive Head and Neck Squamous-Cell Carcinoma Phase 2
Recruiting NCT05581004 - A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors Phase 1
Completed NCT04606940 - Study of Circulating Tumor DNA (ctDNA) Kinetics in Immuno-oncology (IO-KIN)
Recruiting NCT03356587 - A Biomarker-driven, Open Label, Single Arm, Multicentre Phase II Study of Abemaciclib in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Who Failed to Platinum-based Therapy Phase 2
Terminated NCT04272333 - Intratumoral Microdosing of Motolimod in HNSCC Early Phase 1
Completed NCT03367780 - Dose-Effect Relation of Salivary Gland Irradiation
Recruiting NCT04141449 - A Multilevel Intervention to Improve Timely Cancer Detection and Treatment Initiation Phase 2
Recruiting NCT04157985 - Evaluating Length of Treatment With PD-1/PD-L1 Inhibitor in Advanced Solid Tumors Phase 3
Recruiting NCT05859074 - A Study of MQ710 With and Without Pembrolizumab in People With Solid Tumor Cancer Phase 1
Recruiting NCT05814666 - Activity and Safety of Danvatirsen and Pembrolizumab in HNSCC Phase 2
Recruiting NCT04279509 - Selecting Chemotherapy With High-throughput Drug Screen Assay Using Patient Derived Organoids in Patients With Refractory Solid Tumours (SCORE) N/A
Recruiting NCT03526835 - A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors Phase 1/Phase 2
Withdrawn NCT06090318 - Milademetan in Combination With Atezolizumab in Patients With Advanced Solid Tumors With CDKN2A Loss Phase 1/Phase 2