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Phase II study evaluating peptide-based immunotherapies as monotherapy for 3 weeks prior to standard treatment for head and neck cancer.
EU CTIS ID: 2024-513447-82-00
What this study is testing
To evaluate a T-cell peptide specific response in the blood.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- Nasopharynx cancer, unknown primary and nasal cavity and paranasal sinuses carcinomas.
- 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.
- 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.
- Pregnant woman and women who are expecting to conceive.
- Breastfeeding women.
- Patients expected to father children within the projected duration of the trial.
See the full eligibility criteria
Who can join
- 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.
What rules you out
- Nasopharynx cancer, unknown primary and nasal cavity and paranasal sinuses carcinomas.
- 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.
- 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.
- Pregnant woman and women who are expecting to conceive.
- Breastfeeding women.
- Patients expected to father children within the projected duration of the trial.
- 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, uncon-trolled 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 insuffi-ciency) 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 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.
- Any psychiatric, psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.