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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04459715




Registration number
NCT04459715
Ethics application status
Date submitted
30/06/2020
Date registered
7/07/2020

Titles & IDs
Public title
A Study of Xevinapant (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 (TrilynX)
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)
Secondary ID [1] 0 0
2020-000377-25
Secondary ID [2] 0 0
MS202359_0006
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Squamous Cell Carcinoma of the Head and Neck 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Xevinapant (Debio 1143)
Treatment: Drugs - Cisplatin
Treatment: Other - Intensity Modulation Radiation Therapy (IMRT)
Treatment: Drugs - Placebo

Experimental: Xevinapant (Debio 1143) - Participants will receive:

Concomitant chemo-radiation therapy period (Cycles 1-3):

* Radiotherapy
* Cisplatin
* Xevinapant (Debio 1143)

Monotherapy period (Cycles 4-6):

• Xevinapant (Debio 1143)

Active comparator: Placebo - Participants will receive:

Concomitant chemo-radiation therapy period (Cycles 1-3):

* Radiotherapy
* Cisplatin
* Matched placebo

Monotherapy period (Cycles 4-6):

• Matched placebo


Treatment: Drugs: Xevinapant (Debio 1143)
Xevinapant (Debio 1143) administrated as oral solution from Day 1 to 14, every 21-day cycle.

Treatment: Drugs: Cisplatin
Cisplatin administered as an IV infusion every 3 weeks (Q3W).

Treatment: Other: Intensity Modulation Radiation Therapy (IMRT)
70 Gy given in 35 fractions over 7 weeks.

Treatment: Drugs: Placebo
Matched placebo administrated as oral solution from Day 1 to 14, every 21-day cycle.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Event-Free Survival (EFS)
Timepoint [1] 0 0
Up to 5 years
Secondary outcome [1] 0 0
Overall survival (OS)
Timepoint [1] 0 0
Up to 5 years
Secondary outcome [2] 0 0
Progression-Free Survival (PFS)
Timepoint [2] 0 0
Up to 5 years
Secondary outcome [3] 0 0
Locoregional Control (LRC)
Timepoint [3] 0 0
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)
Secondary outcome [4] 0 0
Objective Response Rate (ORR)
Timepoint [4] 0 0
Up to 5 years
Secondary outcome [5] 0 0
Complete Response Rate (CRR)
Timepoint [5] 0 0
Up to 5 years
Secondary outcome [6] 0 0
Duration of Response (DOR)
Timepoint [6] 0 0
Up to 5 years
Secondary outcome [7] 0 0
Number of Participants with Radical Salvage Surgery
Timepoint [7] 0 0
Up to 5 years
Secondary outcome [8] 0 0
Time to Subsequent Systemic Cancer Treatments
Timepoint [8] 0 0
Up to 5 years
Secondary outcome [9] 0 0
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
Timepoint [9] 0 0
From signed informed consent to EOS (within 6.8 years)
Secondary outcome [10] 0 0
Changes from Baseline in Global Health Status/Quality of Life (GHS/QoL) and Fatigue Symptom
Timepoint [10] 0 0
Prior to the first dose of study treatment (Baseline) and at the time of last follow-up (Up to 5 years)
Secondary outcome [11] 0 0
Changes from Baseline in Swallowing and Pain Symptoms
Timepoint [11] 0 0
Prior to the first dose of study treatment (Baseline) and at the time of last follow-up (Up to 5 years)

Eligibility
Key inclusion criteria
* Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1
* Histologically confirmed diagnosis of 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 Edition.) 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 Response evaluation criteria in solid tumors (RECIST) version 1.1
* Peripheral neuropathy less than (<) grade 2
* Adequate hematologic, renal and hepatic function
* Other protocol defined inclusion criteria may apply
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Primary tumor of nasopharynx, 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. No albumin transfusions are allowed within 2 weeks before randomization
* Known allergy to Xevinapant (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
* other protocol defined exclusion criteria may apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/08/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/09/2024
Sample size
Target
Accrual to date
Final
730
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Ashford Cancer Centre Research, Tennyson Centre - Adelaide
Recruitment hospital [2] 0 0
St Vincents Hospital - Darlinghurst
Recruitment hospital [3] 0 0
St Vincents Hospital Melbourne - Fitzroy
Recruitment hospital [4] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [5] 0 0
Wollongong Hospital - Wollongong
Recruitment hospital [6] 0 0
Princess Alexandra Hospital, Cancer Trials Unit - Woolloongabba
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Darlinghurst
Recruitment postcode(s) [3] 0 0
- Fitzroy
Recruitment postcode(s) [4] 0 0
- Melbourne
Recruitment postcode(s) [5] 0 0
- Wollongong
Recruitment postcode(s) [6] 0 0
- Woolloongabba
Recruitment outside Australia
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Country [202] 0 0
United Kingdom
State/province [202] 0 0
Aberdeen
Country [203] 0 0
United Kingdom
State/province [203] 0 0
Chelsea
Country [204] 0 0
United Kingdom
State/province [204] 0 0
Glasgow
Country [205] 0 0
United Kingdom
State/province [205] 0 0
Guildford
Country [206] 0 0
United Kingdom
State/province [206] 0 0
London
Country [207] 0 0
United Kingdom
State/province [207] 0 0
Manchester
Country [208] 0 0
United Kingdom
State/province [208] 0 0
Northwood
Country [209] 0 0
United Kingdom
State/province [209] 0 0
Nottingham
Country [210] 0 0
United Kingdom
State/province [210] 0 0
Southampton
Country [211] 0 0
United Kingdom
State/province [211] 0 0
Sutton
Country [212] 0 0
United Kingdom
State/province [212] 0 0
Wirral

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
EMD Serono Research & Development Institute, Inc.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
GORTEC (Head and Neck Oncology and Radiotherapy Group)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Merck KGaA, Darmstadt, Germany
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Responsible
Address 0 0
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR), Analytic code
When will data be available (start and end dates)?
Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union
Available to whom?
Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://bit.ly/IPD21


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04459715