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Radiotherapy plus xevinapant or placebo in older patients with locally advanced head and neck cancer
EU CTIS ID: 2022-502339-20-00
What this study is testing
The primary objective is to assess the benefit of adding xevinapant to RT in terms of duration of locoregional event-free survival (LREFS) in older patients with LA-HNSCC
- 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
- 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.
You likely can't join if
- 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.
See the full eligibility 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).
- 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
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
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. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom. 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.