Phase II study evaluating peptide-based immunotherapies as monotherapy for 3 weeks prior to standard treatment for head and neck cancer.

Korábbi kezelés

• Any malignancy (other than SCCHN, 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.
• Previous exposure to immunotherapy.
• Has received a live vaccine within 30 days prior to the first dose of trial treatment
• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing ex-ceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of trial treatment.

Más betegség

• Nasopharynx cancer, unknown primary and nasal cavity and paranasal sinuses carcinomas.
• 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, uncon-trolled ventricular arrhythmia, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome).
• 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 insuffi-ciency) is not considered a form of systemic treatment and is allowed.
• Any psychiatric, psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

Laborértékek

• 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 preg-nancy test will be required.

Egyéb

• Pregnant woman and women who are expecting to conceive.
• Breastfeeding women.
• Patients expected to father children within the projected duration of the trial.

• Men and women ≥ 18 years of age on day of signing informed consent.
• 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: a. Not a woman of childbearing potential (WOCBP). b. 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 - see Appendix H).
• Histologically proven squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx.
• Patients selected for a curative 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.
• ECOG performance status 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.