NCT04459715 : A Randomized, Double-Blind Placebo-Controlled, Phase 3 Study of Debio 1143 in Combination With Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiotherapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy (TrilynX)

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Multiple<Br/>Treatment TypesTypeMultiple
Treatment Types

ThreePhase Three

18+Age Over 18

Head and Neck<br/>CancersCancer LocationHead and Neck
Cancers

Multiple treatment types,Radiotherapy,Systemic therapy,Treatment | Head and neckHead and neck,Oropharynx,Throat (hypopharynx),Voice box (larynx)

Trial Overview Read MoreRead more

This phase III trial is trying to demonstrate the benefits of adding the oral drug, Debio 1143, to chemoradiotherapy (CRT) treatment in patients with locally advanced squamous cell carcinoma of the head and neck.
 

This trial is treating patients with squamous cell carcinoma of the head and neck.

This is a systemic therapy and radiotherapy trial.

You may be able to join this trial if:

  • You have been diagnosed with cancer, but have not received any treatment.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A Randomized, Double-Blind Placebo-Controlled, Phase 3 Study of Debio 1143 in Combination With Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiotherapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy (TrilynX)

Cooperative Group

GORTEC (Head and Neck Oncology and Radiotherapy Group)

Commercial Sponsor

Debiopharm International SA

Summary

Eligible patients will be randomised to receive concomitant chemo-radiation therapy containing radiotherapy, Cisplatin and Debio 1143 (or a matched placebo) in Cycles 1-3, followed by Debio 1143 (or a matched placebo) monotherapy in Cycles 4-6.

Recruiting Hospitals Read MoreRead more

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Enquiries Line Coordinator
clinicaltrials.enquiries@petermac.org
03 8559 7456 (9am-2pm, Mon-Fri)

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

Next