Activity and Safety of Peptide-based Immunotherapy in Patients With Squamous Cell Carcinoma of th… (NCT04445064) | Clinical Trial Compass
TerminatedPhase 2
Activity and Safety of Peptide-based Immunotherapy in Patients With Squamous Cell Carcinoma of the Head and Neck.
Stopped: unmet primary endpoint
Belgium17 participantsStarted 2020-08-14
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with a T-cell peptide-specific response to the vaccine as assessed by an interferon(INF)-γ ELISpot assay.
Timeframe: 2 years
Trial details
NCT IDNCT04445064
SponsorCliniques universitaires Saint-Luc- Université Catholique de Louvain
. Eastern Cooperative Oncology Group (ECOG) performance status scale 0-1 and Karnofsky score \> or = 70.
Exclusion criteria
. 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.