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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)
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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)
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Secondary ID [1]
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2020-000377-25
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Secondary ID [2]
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MS202359_0006
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Squamous Cell Carcinoma of the Head and Neck
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Condition category
Condition code
Cancer
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Non melanoma skin cancer
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Cancer
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Kidney
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Cancer
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Head and neck
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Event-Free Survival (EFS)
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Assessment method [1]
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EFS is the time from the date of randomization to the date of first record of disease progression or death.
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Timepoint [1]
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Up to 5 years
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Secondary outcome [1]
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Overall survival (OS)
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Assessment method [1]
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OS is the time from randomization to death due to any cause.
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Timepoint [1]
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Up to 5 years
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Secondary outcome [2]
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Progression-Free Survival (PFS)
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Assessment method [2]
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PFS is the time from randomization to the earliest between PFS event or End of Study (EOS)
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Timepoint [2]
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Up to 5 years
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Secondary outcome [3]
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Locoregional Control (LRC)
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Assessment method [3]
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Timepoint [3]
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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)
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Secondary outcome [4]
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Objective Response Rate (ORR)
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Assessment method [4]
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ORR defined as proportion of participants with complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, as assessed by Blinded Independent Review Committee (BIRC).
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Timepoint [4]
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Up to 5 years
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Secondary outcome [5]
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Complete Response Rate (CRR)
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Assessment method [5]
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CRR defined as proportion of participants with complete response (CR) as assessed by Blinded Independent Review Committee (BIRC).
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Timepoint [5]
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Up to 5 years
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Secondary outcome [6]
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Duration of Response (DOR)
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Assessment method [6]
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Duration of response (DoR) defined as the time from the first evidence of response (partial or complete, as assessed by the BIRC according to RECIST v1.1) to the first occurrence of progression (radiological or clinical, as assessed by the BIRC) or death from any cause.
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Timepoint [6]
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Up to 5 years
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Secondary outcome [7]
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Number of Participants with Radical Salvage Surgery
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Assessment method [7]
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Timepoint [7]
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Up to 5 years
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Secondary outcome [8]
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Time to Subsequent Systemic Cancer Treatments
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Assessment method [8]
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Timepoint [8]
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Up to 5 years
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Secondary outcome [9]
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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
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Assessment method [9]
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0
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Timepoint [9]
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From signed informed consent to EOS (within 6.8 years)
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Secondary outcome [10]
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Changes from Baseline in Global Health Status/Quality of Life (GHS/QoL) and Fatigue Symptom
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Assessment method [10]
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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)
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Timepoint [10]
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Prior to the first dose of study treatment (Baseline) and at the time of last follow-up (Up to 5 years)
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Secondary outcome [11]
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Changes from Baseline in Swallowing and Pain Symptoms
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Assessment method [11]
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Change from baseline in swallowing, and pain symptoms using the EORTC Head and Neck Questionnaire (EORTC QLQ-H\&N35)
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Timepoint [11]
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Prior to the first dose of study treatment (Baseline) and at the time of last follow-up (Up to 5 years)
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
7/08/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/04/2027
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Actual
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Sample size
Target
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Accrual to date
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Final
730
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Ashford Cancer Centre Research, Tennyson Centre - Adelaide
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Recruitment hospital [2]
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St Vincents Hospital - Darlinghurst
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St Vincents Hospital Melbourne - Fitzroy
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment hospital [5]
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Wollongong Hospital - Wollongong
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Recruitment hospital [6]
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Princess Alexandra Hospital, Cancer Trials Unit - Woolloongabba
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Recruitment postcode(s) [1]
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- Adelaide
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Recruitment postcode(s) [2]
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- Darlinghurst
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Recruitment postcode(s) [3]
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- Fitzroy
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- Melbourne
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Recruitment postcode(s) [5]
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- Wollongong
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Recruitment postcode(s) [6]
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- Woolloongabba
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Recruitment outside Australia
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Lausanne
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Kyiv
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Wirral
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
EMD Serono Research & Development Institute, Inc.
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Address
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Other collaborator category [1]
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Other
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Name [1]
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GORTEC (Head and Neck Oncology and Radiotherapy Group)
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Commercial sector/industry
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Merck KGaA, Darmstadt, Germany
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Ethics approval
Ethics application status
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Summary
Brief summary
The primary objective of the study is to demonstrate superior efficacy of Xevinapant (Debio 1143) vs placebo when added to chemoradiotherapy (CRT) in locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN).
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Trial website
https://clinicaltrials.gov/study/NCT04459715
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Trial related presentations / publications
Bourhis J, Burtness B, Licitra LF, Nutting C, Schoenfeld JD, Omar M, Bouisset F, Nauwelaerts H, Urfer Y, Zanna C, Cohen EE. Xevinapant or placebo plus chemoradiotherapy in locally advanced squamous cell carcinoma of the head and neck: TrilynX phase III study design. Future Oncol. 2022 May;18(14):1669-1678. doi: 10.2217/fon-2021-1634. Epub 2022 Feb 17.
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Public notes
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Contacts
Principal investigator
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Medical Responsible
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Address
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Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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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
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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
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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
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: http://bit.ly/IPD21
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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