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 range18 Years
SexALL
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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.
✓. 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.
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.
✕. 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.