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Trial Summary

The primary objective of the study is to demonstrate superior efficacy of Debio 1143 vs placebo when added to chemoradiotherapy (CRT) in locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN).

Acronym:

TrilynX

ACTRN/NCT /ethics:

NCT04459715

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).

Sponsor / Cooperative group:

Debiopharm International SA

Trial & Patient Characteristics

Cancer TypeHead and Neck; Melanoma & other skin
Trial TypeTreatment
PhasePhase III
Age Range18 years and older
SexBoth
Tumour Stream squamous cell carcinoma of the head and neck
Cancer StageLocally Recurrent or Locally Advanced
Anticipated Start Date2020-08-03
Anticipated End Date2027-04-30

Participating Hospitals

HospitalAshford Cancer Centre Research
Clinical Trial CoordinatorSue Yeend
Emailsyeend@adelaidecancercentre.com.au
Phone08 8292 2240
Principal InvestigatorDr Sarwan Bishnoi
Recruitment StatusNot Yet Recruiting