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).
Title
- Brief Title: A Study of Debio 1143 (Xevinapant) 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
| Drug | Synonyms | Arms |
|---|
| Debio 1143 | xevinapant | Debio 1143 |
| Cisplatin | | Debio 1143 |
| Placebo | | Placebo |
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
| Name | Type | Description | Interventions |
|---|
| Debio 1143 | Experimental | Participants will receive:
Concomitant chemo-radiation therapy period (Cycles 1-3):
Radiotherapy
Cisplatin
Debio 1143
Monotherapy period (Cycles 4-6):
• Debio 1143 | |
| Placebo | Active Comparator | Participants will receive:
Concomitant chemo-radiation therapy period (Cycles 1-3):
Radiotherapy
Cisplatin
Matched placebo
Monotherapy period (Cycles 4-6):
• Matched 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, carboplatin, other platinum-based agent or any
excipient known to be present in any of these products 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
August 26, 2021
