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Randomized trial of avelumab-cetuximab-Radiotherapy versus standards of care in the head and neck cancers
EU CTIS ID: 2024-513964-24-00
What this study is testing
To demonstrate that treatment with avelumab in combination with cetuximab-RT is superior to SOC cisplatin-RT and/or to SOC cetuximab-RT alone in terms of PFS in front-line patients with locally advanced SCCHN. Each cohort will be analyzed separately.
- Therapeutic confirmatory (Phase III)
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
- Age > 18 years and ≤ 80 years
- Performance Status ECOG 0-1
- Histologically confirmed squamous cell carcinoma, previously untreated
- Stage III, stage IVa (i.e. operable, but not operated) or IVb (non resectable)
- Oral cavity, oropharynx, hypopharynx or larynx
- Determination of the patient’s ability to receive cisplatin 100 mg/m2 for 3 cycles (fit / unfit)** Criteria for determining if a patient is fit for receiving high dose cisplatin: - Calculated creatinine clearance ≥ 60 mL/min or glomerular filtration rate ≥ 60 mL/min/1.73m² (CKD-EPI method recommended), - Absolute neutrophil count ≥1 500/μL, platelets ≥100 000/μL, haemoglobin ≥ 10 g/dL, aspartate (AST) and alanine transaminase (ALT) less than 2 times the upper limit of the normal range (ULN), total bilirubin ≤ 1.5 mg/dL, serum albumin ≥ 35 g/L. - Peripheral neuropathy < grade 2 - No sensorineural hearing loss (confirmed by audiogram) - Cardiac function compatible with hyperhydration with no significant heart disease - No administration of prophylactic phenytoin - Age < 75 years. For patients aged 71-74 years, PS must be 0 and fit according to geriatric evaluation - General clinical state compatible with high dose cisplatin and radiotherapy according to the investigator
You likely can't join if
- Nasopharyngeal, paranasal sinuses, nasal cavity tumours or thyroid cancers
- Concomitant treatment with any drug on the prohibited medication list such as live vaccines or systemic corticoids at dose > 10 mg/day prednisone or equivalent. Live vaccines administered more than 30 days before study entry are permitted.
- Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.
- Squamous cell carcinoma involving cervical neck nodes with unknown primary site
- Metastatic disease (stage IVc)
- Active viral infection (HIV, Hepatitis B/C) or known history of positive test for HIV
See the full eligibility criteria
- Age > 18 years and ≤ 80 years
- Performance Status ECOG 0-1
- Histologically confirmed squamous cell carcinoma, previously untreated
- Stage III, stage IVa (i.e. operable, but not operated) or IVb (non resectable)
- Oral cavity, oropharynx, hypopharynx or larynx
- Determination of the patient’s ability to receive cisplatin 100 mg/m2 for 3 cycles (fit / unfit)** Criteria for determining if a patient is fit for receiving high dose cisplatin: - Calculated creatinine clearance ≥ 60 mL/min or glomerular filtration rate ≥ 60 mL/min/1.73m² (CKD-EPI method recommended), - Absolute neutrophil count ≥1 500/μL, platelets ≥100 000/μL, haemoglobin ≥ 10 g/dL, aspartate (AST) and alanine transaminase (ALT) less than 2 times the upper limit of the normal range (ULN), total bilirubin ≤ 1.5 mg/dL, serum albumin ≥ 35 g/L. - Peripheral neuropathy < grade 2 - No sensorineural hearing loss (confirmed by audiogram) - Cardiac function compatible with hyperhydration with no significant heart disease - No administration of prophylactic phenytoin - Age < 75 years. For patients aged 71-74 years, PS must be 0 and fit according to geriatric evaluation - General clinical state compatible with high dose cisplatin and radiotherapy according to the investigator
- Nasopharyngeal, paranasal sinuses, nasal cavity tumours or thyroid cancers
- Concomitant treatment with any drug on the prohibited medication list such as live vaccines or systemic corticoids at dose > 10 mg/day prednisone or equivalent. Live vaccines administered more than 30 days before study entry are permitted.
- Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.
- Squamous cell carcinoma involving cervical neck nodes with unknown primary site
- Metastatic disease (stage IVc)
- Active viral infection (HIV, Hepatitis B/C) or known history of positive test for HIV
- Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
- Active immunodeficiency or ongoing immunosuppressive therapy
- Interstitial lung disease
- Active infection
- Any prior or current treatment for invasive head and neck cancer. This will include but is not limited to: prior tyrosine kinase inhibitors, any monoclonal antibody, induction chemotherapy, prior surgical resection or RT, or use of any investigational agent. Minor surgery in the head and neck area (e.i. dental extraction diagnostic biopsy) are authorized if performed more than 1 week before study entry and under condition of wound healing.
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland. Enter your location above to see the nearest site and check your eligibility.
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.