Activity and safety of a vaccine in head and neck cancer

Activity and safety of peptide-based immunotherapy in an umbrella window pre-operative opportunity phase II study in patients with squamous cell carcinoma of the head and neck. - HN1901

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-000120-19-BE

Enrollment

Registered

2020-02-10

Start date

2020-05-05

Completion date

Unknown

Last updated

2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and neck cancer elective for surgery

Interventions

Product Name: IO102 Product Code: IO102 Pharmaceutical Form: Solution for injection INN or Proposed INN: IO102 Other descriptive name: MONTANIDE Concentration unit: mg/ml milligram(s)/millilitre Conce

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age = 18 Squamous cell carcinome of hypopharynx, larynx, orolarynx, oral cavity Elective for curative treatment Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: Distant metastases Squamous cell carcinoma of nasal and sinusal cavities, nasopharynx and unknown primary

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate a t-cell peptide-specific response;Secondary Objective: To assess the safety and tolerability of peptide vaccine(s); To evaluate the anti tumor effect of peptide vaccine(s); To evaluate the pre-operative activity of peptide vaccine(s);Primary end point(s): To evaluate a T-cell peptide-specific response;Timepoint(s) of evaluation of this end point: One or two days before curative surgery	—

Measure

Time frame

Main Objective: To evaluate a t-cell peptide-specific response;Secondary Objective: To assess the safety and tolerability of peptide vaccine(s); To evaluate the anti tumor effect of peptide vaccine(s); To evaluate the pre-operative activity of peptide vaccine(s);Primary end point(s): To evaluate a T-cell peptide-specific response;Timepoint(s) of evaluation of this end point: One or two days before curative surgery

—

Secondary

Measure	Time frame
Secondary end point(s): To assess the safety and tolerability of peptides vaccine(s); To evaluate the anti tumor effect of peptide vaccine(s); To evaluate the pre-operative activity of peptide vaccine(s);Timepoint(s) of evaluation of this end point: Two days and 4 weeks after curative treatment on blood samples and on tissues samples taken during endoscopies	—

Countries

Belgium

Contacts

Public ContactClinical Trial Center of CUSL

Cliniques universitaires Saint-Luc

guichetacademique-saintluc@uclouvain.be+3227648540

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026