Radiotherapy plus xevinapant or placebo in older patients with locally advanced head and neck cancer

Phase 1

Recruiting

Conditions: Squamous cell carcinoma of head and neck
MedDRA version: 21.0Level: PTClassification code: 10060121Term: Squamous cell carcinoma of head and neck Class: 100000004864
Therapeutic area: Diseases [C] - Otorhinolaryngologic Diseases [C09]
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]

Registration Number: CTIS2022-502339-20-00

Lead Sponsor: European Organisation For Research And Treatment Of Cancer

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 244

Inclusion Criteria

Age = 70 years., Written informed consent must be signed according to ICH/GCP, and national/local regulations, Pathologically proven new diagnosis of HNSCC of oral cavity, oropharynx, hypopharynx and larynx tumour., cT3-4 cN0 cM0 or cT1-4 cN1-3 cM0 except for cT1-2 cN1 p16 positive oropharyngeal cancer (AJCC 8th edition)., HPV status using p16 immunohistochemistry (IHC) available for oropharyngeal squamous cell carcinoma., Measurable disease per RECIST 1.1., ECOG PS = 1., Intention to treat with curative intent primary radiotherapy alone., Able to swallow liquids or has an adequately functioning feeding tube, gastrostomy or jejunostomy placed., Adequate hematologic, renal, and hepatic function as indicated by: • Creatinine clearance = 30 mL/min, measured with the Cockroft and Gault formula. • Absolute neutrophil count = 1 500 cells/µL. • Platelets = 100 000 cells/µL. • Hemoglobin = 9.0 g/dL or =5.6 mmol/L (blood transfusions during screening are permitted). • AST and ALT = 3.0 × upper limit of normal (ULN). • Total bilirubin = 1.5 × ULN (up to 2.0 × ULN is allowed, if the direct bilirubin level is normal and the elevation is limited to indirect bilirubin).

Exclusion Criteria

Unknown primary, primary nasopharynx and paranasal sinus, Any uncontrolled, intercurrent illness or clinical situation that would in the judgment of investigator, limit compliance with study requirements. This includes but is not limited to uncontrolled active infections, defined as any infection requiring IV antibiotics within 7 days prior to enrolment., Two primaries., Any previous or current treatment for invasive head and neck cancer, including induction chemotherapy, surgery, concomitant chemotherapy and cetuximab., Gastrointestinal disorders that could affect drug absorption., Another malignancy in the previous 3 years with exception of curatively treated disease with no evidence of recurrence., Known allergy to xevinapant or any excipient known to be present in active or placebo formulation., Active gastrointestinal bleeding, or any other uncontrolled bleeding requiring more than 2 red blood cell transfusions or 4 units of packed red blood cells within 4 weeks prior to enrolment, Decompensated or symptomatic liver cirrhosis (Child-Pugh score: B or C), Impaired cardiovascular function or clinically significant cardiovascular diseases