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A Study of Debio 1143 in Combination With Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiotherapy in Participants With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy

NCT04459715

Description:

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).

Related Conditions:
  • Hypopharyngeal Squamous Cell Carcinoma
  • Laryngeal Squamous Cell Carcinoma
  • Oropharyngeal Squamous Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: A Study of Debio 1143 in Combination With Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiotherapy in Participants With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy
  • Official 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)

Clinical Trial IDs

  • ORG STUDY ID: Debio 1143-SCCHN-301
  • SECONDARY ID: 2020-000377-25
  • NCT ID: NCT04459715

Conditions

  • Carcinoma, Squamous Cell of the Head and Neck

Interventions

DrugSynonymsArms
Debio 1143Debio 1143
CisplatinDebio 1143
PlaceboPlacebo

Purpose

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).

Trial Arms

NameTypeDescriptionInterventions
Debio 1143ExperimentalParticipants will receive: Concomitant chemo-radiation therapy period (Cycles 1-3): Radiotherapy Cisplatin Debio 1143 Monotherapy period (Cycles 4-6): • Debio 1143
  • Debio 1143
  • Cisplatin
PlaceboActive ComparatorParticipants will receive: Concomitant chemo-radiation therapy period (Cycles 1-3): Radiotherapy Cisplatin Matched placebo Monotherapy period (Cycles 4-6): • Matched placebo
  • Cisplatin
  • Placebo

Eligibility Criteria

        Inclusion Criteria:

          -  Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1

          -  Histologically confirmed diagnosis in previously untreated Locally Advanced Squamous
             Cell Carcinoma of the Head and Neck (LA-SCCHN) participant (stage III, IVa or IVb
             according to the American Joint Committee on Cancer(AJCC))/Classification of malignant
             tumors: T=size of the primary tumor, N=regional lymph node involvement, M=distant
             metastasis (TNM) Staging System, 8th Ed.) suitable for definitive ChemoRadiotherapy
             (CRT), of at least one of the following sites: oropharynx, hypopharynx and larynx

          -  For OroPharyngeal Cancer (OPC) participants, primary tumors must be human
             papillomavirus (HPV)-negative as determined by p16 expression using
             immunohistochemistry

          -  Evaluable tumor burden (measurable and/or non-measurable tumor lesions) assessed by
             computed tomography scan (CT-scan) or magnetic resonance imaging (MRI), based on
             RECIST v 1.1

          -  Peripheral neuropathy < grade 2

          -  Adequate hematologic, renal and hepatic function

        Exclusion Criteria:

          -  Primary tumor of nasopharyngeal, paranasal sinuses, nasal or oral cavity, salivary,
             thyroid or parathyroid gland pathologies, skin or unknown primary site

          -  Metastatic disease (stage IVc as per AJCC/TNM, 8th Ed.)

          -  Prior definitive or adjuvant Radiotherapy (RT) and/or radical surgery to the head and
             neck region which may jeopardize the primary tumor irradiation plan, or any other
             prior SCCHN systemic treatment, including investigational agents

          -  Documented weight loss of >10% during the last 4 weeks prior to randomization (unless
             adequate measures are undertaken for nutritional support), OR plasmatic albumin < 3.0
             g/dL

          -  Known allergy to Debio 1143, cisplatin or any excipient known to be present in
             Debio1143 or in the placebo formulation.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Event-Free Survival (EFS)
Time Frame:Up to 5 years
Safety Issue:
Description:EFS is the time from the date of randomization to the date of first record of disease progression or death.

Secondary Outcome Measures

Measure:Progression-Free Survival (PFS)
Time Frame:Up to 5 years
Safety Issue:
Description:PFS is the time from randomization to the earliest between PFS event or End of Study (EOS)
Measure:Overall survival (OS)
Time Frame:Up to 5 years
Safety Issue:
Description:OS is the time from randomization to death due to any cause.
Measure:Locoregional Control (LRC)
Time Frame:From randomization to the earliest between PFS event (progression at the site of the primary tumor or the locoregional lymph nodes) or EOS (Up to 5 years)
Safety Issue:
Description:
Measure:Safety and Tolerability as assessed by incidence and severity of Adverse Events (AEs), Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Changes in Laboratory Values, Vital Signs, Electrocardiogram (ECGs) and Extent of Exposure
Time Frame:From signed informed consent to EOS (within 6.8 years)
Safety Issue:
Description:
Measure:Changes from Baseline in Global Health Status/Quality of Life (GHS/QoL) and Fatigue Symptom
Time Frame:Prior to the first dose of study treatment (Baseline) and at the time of last follow-up (Up to 5 years)
Safety Issue:
Description:Change from baseline in GHS/QoL and Fatigue Symptom using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30)
Measure:Changes from Baseline in Swallowing and Pain Symptoms
Time Frame:Prior to the first dose of study treatment (Baseline) and at the time of last follow-up (Up to 5 years)
Safety Issue:
Description:Change from baseline in swallowing, and pain symptoms using the EORTC Head and Neck Questionnaire (EORTC QLQ-H&N35)

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Debiopharm International SA

Last Updated

September 18, 2020