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Safety and Efficacy of VB10.16 and Pembrolizumab in Patients With Head-Neck Squamous Cell Carcinoma

ConditionsHPV Positive Oropharyngeal Squamous Cell CarcinomaHNSCC
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNykode Therapeutics ASA

About this trial

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:

* Phase 1: Dose escalation to evaluate safety and determine the recommended phase 2 dose (RP2D) of VB10.16 * Phase 2: Randomized comparison of VB10.16 in combination with pembrolizumab versus pembrolizumab monotherapy The goal of Phase 1 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. The randomized Phase 2 will consist of 2 parallel arms exploring VB10.16 at the selected RP2D from the escalation phase in combination with pembrolizumab SoC (experimental arm, Arm A), versus pembrolizumab alone (control arm, Arm B).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥18 years of age (or as per national legal age of trial consent, whichever is higher) at date of signing the informed consent form (ICF).

Histologically or cytologically confirmed r/m HNSCC, located in the oropharynx, considered incurable by local therapy and eligible for monotherapy with pembrolizumab.

HPV16 positivity of r/m oropharyngeal HNSCC confirmed by designated central laboratory.

PD-L1 positivity (CPS ≥1) using the validated PD-L1 IHC 22C3 pharmDx (DAKO) assay.

Disqualifiers

Has disease that is suitable for local therapy with curative intent.

Has progressive disease ≤6 months after completion of curatively intended concurrent chemoradiotherapy for locoregionally advanced r/m oropharyngeal HNSCC.

Primary tumor site of the oral cavity, hypopharynx, larynx or nasopharynx (any histology).

Rapidly progressing disease (e.g., tumor bleeding, uncontrolled tumor pain) in the opinion of the investigator. PRIOR, CONCURRENT, OR FUTURE INTERVENTIONS

Trial design

Design model

Parallel

Treatments tested in this trial

  • VB10.16

    Biological/Vaccine

    Intramuscular injection using a PharmaJet needle-free injection system

  • Pembrolizumab

    Drug

    Intravenous infusion.

Treatment groups

110 Participants
are divided into 5 treatment groups
Group A: Phase1: Dose Escalation: 3 mg VB10.16 + PembrolizumabExperimental treatment 2 interventions
Group B: Phase 1: Dose Escalation: 6 mg VB10.16 + PembrolizumabExperimental treatment 2 interventions
Group C: Phase 1: Dose Escalation: 9 mg VB10.16 + PembrolizumabExperimental treatment 2 interventions
Group D: Phase 2: Arm A: VB10.16 (recommended Phase 2 Dose) + PembrolizumabExperimental treatment 2 interventions
Group E: Phase 2: Active comparator ph 2, Arm B: Pembrolizumab MonotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Phase 1: Dose Escalation: Dose Limiting Toxicities (DLT)

Proportion of patient with Dose Limiting Toxicities (DLTs).

Time frame
42 days
2

Phase 2: Dose expansion: Objective Response Rate (ORR)

Objective Response Rate (ORR), defined as the proportion of patients who have either confirmed CR or confirmed PR as best overall response per RECIST 1.1.

Time frame
Up to 2 years
3

Phase 2: Dose Expansion: Progression-Free Survival (PFS)

PFS defined as the time from randomization to the first documented disease progression according to RECIST 1.1 or death from any cause, whichever occurs first.

Time frame
Up to 2 years

Secondary outcomes

1

Phase 2: Dose Expansion: Disease Control Rate (DCR)

Disease control rate (DCR), defined as the proportion of patients who have either confirmed CR, confirmed PR, or SD as BOR according to RECIST 1.1.

Time frame
Up to 2 years
2

Phase 2: Dose Expansion: Duration of response (DOR)

Duration of response (DOR), defined as time from the date of first documented response of CR or PR to the date of the first documented progression or death due to any cause.

Time frame
Up to 2 years
3

Phase 2: Dose Expansion: Duration of complete response (DOCR)

Duration of complete response (DOCR), defined as time from the date of first documented response of CR to the date of the first documented progression or death due to any cause.

Time frame
Up to 2 years
4

Phase 2: Dose Expansion: Duration of Disease Control (DODC)

Duration of Disease Control (DODC), defined as time from the date of first documented response of CR, PR or SD to the date of the first documented progression or death due to any cause.

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nykode Therapeutics ASA

Lead sponsor

Merck Sharp & Dohme LLC

Collaborator

Source ClinicalTrials.gov
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