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

NCT04445064 | Terminated Phase 2 DMC

• 1 other identifier: HN1901
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oropharynx Squamous Cell Carcinoma; Larynx Squamous Cell Carcinoma; Hypopharynx Squamous Cell Carcinoma; Oral Cavity Squamous Cell Carcinoma

Keywords

vaccine; immunotherapy; squamous cell carcinoma; head and neck

Outcome Measures

Primary Outcomes (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.

  2 years

Secondary Outcomes (3)

• Number of participants experiencing toxicity

  2 years

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

  2 years

• Objective response rate (ORR) by RECIST Version 1.1

  2 years

Study Arms (3)

Arm A: IO102 vaccine

EXPERIMENTAL

Randomization between arm A and B. Patients in arm A will receive IO102 3 to 4 times prior to curative treatment

Biological: IO102

Arm B: Control group

NO INTERVENTION

Randomization between arm A and B

Arm C: IO103

EXPERIMENTAL

No randomization. Patients in arm C will receive IO103 3 to 4 times prior to curative treatment

Biological: IO103

Interventions

IO102 BIOLOGICAL

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

Arm A: IO102 vaccine

IO103 BIOLOGICAL

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

Arm C: IO103

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Carcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms, Squamous Cell

Study Officials

• Jean-Pascal Machiels

  Insitut de Recherche Expérimentale et Clinique, pôle MIRO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicentric

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: June 24, 2020
• Study Start: August 14, 2020
• Primary Completion: June 8, 2024
• Study Completion: March 20, 2025
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

BE (1)