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Oropharynx Squamous Cell CarcinomaPhase 2HN1901NCT04445064

Activity and Safety of Peptide-based Immunotherapy in Patients With Squamous Cell Carcinoma of the Head and Neck.

A Phase 2 study testing IO102 and IO103 in people with Oropharynx Squamous Cell Carcinoma and Larynx Squamous Cell Carcinoma, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this project is to realize a randomized open-label study (EudraCT number: 2020-000120-19) to evaluate the safety and the anti-tumor activity of peptide(s)-based immunotherapy in an umbrella window pre-operative opportunity phase II study in patients with squamous cell carcinoma of the head and neck. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
IO102 and IO103
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteBelgium
Study dates
14 Aug 2020to 20 Mar 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and women ≥ 18 years of age on day of signing informed consent.
  • Histologically proven squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx.
  • Patients selected for a surgical treatment.
  • No distant metastases.
  • Measurable disease as per RECIST 1.1.
  • No active second malignancy during the last 3 years except non melanomatous skin cancer or carcinoma in situ of the cervix.
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  • The participant provides written signed informed consent for the trial in accordance with ICH-GCP and local legislation prior to admission to the trial.
  • Eastern Cooperative Oncology Group (ECOG) performance status scale 0-1 and Karnofsky score > or = 70.
  • Neutrophil count > 1,500/mm3, platelet count > 75,000/mm3, WBC> or = 3.0/109 L, bilirubin or creatinine < 2 times ULN, ALT or AST < 5 times ULN, Hemoglobin ≥ 9 g/dL.
  • A male participant able to father a child must agree to use contraception starting with the screening visit and throughout the duration of the trial.
  • A female participant is eligible to participate if she is not pregnant not breastfeeding, and at least one of the following conditions applies:
  • Not a woman of childbearing potential (WOCBP).
  • A WOCBP who agrees to follow contraceptive guidance starting with the screening and throughout the duration of the trial. WOCBP are allowed in the trial if they are using proper contraception (follow guidelines from the European Union Heads of Medicines Agency (CTFG, 2014).

Who cannot join

  • Nasopharynx cancer, unknown primary and nasal cavity and paranasal sinuses carcinomas.
  • Previous exposure to immunotherapy.
  • Known diagnosis of immune deficiency or a positive serology of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
  • Active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected) or pre-existing liver cirrhosis.
  • Other uncontrolled active illnesses or nonmalignant systemic disease (examples include, but are not limited to, active infections requiring antibiotics, bleeding disorders, uncontrolled diabetes, uncontrolled ventricular arrhythmia, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome).
  • Has received a live vaccine within 30 days prior to the first dose of trial treatment
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  • Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of trial treatment.
  • Any psychiatric, psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
  • Any malignancy (other than squamous cell carcinoma of the head and neck, non-melanoma skin cancer or localized cervical cancer or localized and presumed cured prostatic cancer or basal cell carcinoma of the skin and carcinoma in situ of the cervix or bladder) within the last 3 years prior to registration.
  • Women of Child Bearing Potential (WOCBP) who has a positive urine pregnancy test (e.g., within 72 hours) prior to treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Pregnant woman and women who are expecting to conceive.
  • Breastfeeding women.
  • Patients expected to father children within the projected duration of the trial.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

Other trials in Belgium

About this study

Official title: Activity and Safety of Peptide-based Immunotherapy in an Umbrella Window-of-opportunity Phase II Study in Patients With Squamous Cell Carcinoma of the Head and Neck.

The purpose of this project is to realize a randomized open-label study (EudraCT number: 2020-000120-19) to evaluate the safety and the anti-tumor activity of peptide(s)-based immunotherapy in an umbrella window pre-operative opportunity phase II study in patients with squamous cell carcinoma of the head and neck.

Read the detailed description

Patients with a head and neck squamous cell carcinoma eligible for curative treatment are eligible for this proof of concept study. The included patients in arm A will receive IO102 subcutaneous at 100μg every week during the three weeks following the first endoscopy. The included patients in am B (control group) won't receive any treatment. The included patients in arm C will receive IO103 subcutaneous at 100μg every week during the three weeks following the first endoscopy.

The main objectives of this study are:

  • To evaluate the T-cell peptide-specific response to the vaccine in a interferon(INF)-γ ELISpot assay.
  • To assess the safety and tolerability of the vaccine.
  • To investigate the decreased action of the IDO enzyme in evaluating the increased tumoral infiltration by CD8+ T-lymphocytes and by measuring the serum levels of kynurenin, tryptophan,...
  • To evaluate the anti-tumor effect (objective response rate, overall survival, disease free- survival, disease specific survival).
  • To evaluate the pre-operative activity of peptide vaccine using MRI (Magnetic Resonance Imaging), DWI-MRI (Diffusion Weighted Imaging-MRI) and MRS (Magnetic Resonance Spectroscopy) to visualize possible significant tumor modifications.
Being tested
IO102, IO103
Keywords
vaccine, immunotherapy, squamous cell carcinoma, head and neck
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Carcinoma, Squamous Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IO102Biological

    100µg each week during the 3 weeks prior to curative treatment (total of 3 to 4 doses maximum)

  • IO103Biological

    100µg each week during the 3 weeks prior to curative treatment (total of 3 to 4 doses maximum)

Study groups in NCT04445064
Study groupRoleWhat they receive
Arm A: IO102 vaccineExperimentalRandomization between arm A and B. Patients in arm A will receive IO102 3 to 4 times prior to curative treatment
Receives: Biological: IO102
Arm B: Control groupNo interventionRandomization between arm A and B
Arm C: IO103ExperimentalNo randomization. Patients in arm C will receive IO103 3 to 4 times prior to curative treatment
Receives: Biological: IO103

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with a T-cell peptide-specific response to the vaccine as assessed by an interferon(INF)-γ ELISpot assay.

    ELISpot responses will be considered positive when the numbers of IFN-γ secreting cells will be at least twofold greater than the mean value of the baseline and with a minimum of 50 spots (per 5 × 10^5 peripheral blood mononuclear cell (PBMC) ) detected.

    Measured: 2 years

Secondary outcomes (3)

  1. Number of participants experiencing toxicity

    Maximum grade of each toxicity and percentage of patients experiencing toxicity as assessed by CTC-NCIv5.0.

    Patients will have blood tests before the second and third administration of the vaccine and 4 weeks after surgery and clinical examinations before each administration of the vaccine and during the 3 months after surgery.

    Measured: 2 years

  2. Increase in CD8+ T-cell density (cells/mm2) between tumour biopsies taken before and after treatment, as demonstrated by immunohistochemistry.

    Measured: 2 years

  3. Objective response rate (ORR) by RECIST Version 1.1

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2020
  2. Study start14 Aug 2020
  3. Primary completion8 Jun 2024
  4. Study completion20 Mar 2025

Why it stopped: unmet primary endpoint

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Multicentric
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04445064
Sponsor's protocol ID
HN1901
Acronym
HN1901
Status last verified
Dec 2025
First submitted
3 Jun 2020
Last updated
16 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IO102 and IO103 in people with Oropharynx Squamous Cell Carcinoma and Larynx Squamous Cell Carcinoma, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: unmet primary endpoint). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with a T-cell peptide-specific response to the vaccine as assessed by an interferon(INF)-γ ELISpot assay. (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04445064.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.

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