Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04459715




Registration number
NCT04459715
Ethics application status
Date submitted
30/06/2020
Date registered
7/07/2020
Date last updated
20/03/2024

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
Active, not recruiting
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
30/04/2027
Actual
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
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
District of Columbia
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
Missouri
Country [14] 0 0
United States of America
State/province [14] 0 0
Nevada
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
North Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Ohio
Country [18] 0 0
United States of America
State/province [18] 0 0
Oklahoma
Country [19] 0 0
United States of America
State/province [19] 0 0
Oregon
Country [20] 0 0
United States of America
State/province [20] 0 0
Pennsylvania
Country [21] 0 0
United States of America
State/province [21] 0 0
South Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
Texas
Country [23] 0 0
United States of America
State/province [23] 0 0
Utah
Country [24] 0 0
United States of America
State/province [24] 0 0
Virginia
Country [25] 0 0
Argentina
State/province [25] 0 0
Buenos Aires
Country [26] 0 0
Argentina
State/province [26] 0 0
Cordoba
Country [27] 0 0
Argentina
State/province [27] 0 0
Santa Fe
Country [28] 0 0
Argentina
State/province [28] 0 0
Viedma
Country [29] 0 0
Austria
State/province [29] 0 0
Graz
Country [30] 0 0
Austria
State/province [30] 0 0
Salzburg
Country [31] 0 0
Austria
State/province [31] 0 0
Vienna
Country [32] 0 0
Belgium
State/province [32] 0 0
Bruxelles
Country [33] 0 0
Belgium
State/province [33] 0 0
Charleroi
Country [34] 0 0
Belgium
State/province [34] 0 0
Edegem
Country [35] 0 0
Belgium
State/province [35] 0 0
Gent
Country [36] 0 0
Belgium
State/province [36] 0 0
La Louvière
Country [37] 0 0
Belgium
State/province [37] 0 0
Leuven
Country [38] 0 0
Belgium
State/province [38] 0 0
Libramont
Country [39] 0 0
Belgium
State/province [39] 0 0
Namur
Country [40] 0 0
Belgium
State/province [40] 0 0
Sint-Niklaas
Country [41] 0 0
Belgium
State/province [41] 0 0
Wilrijk
Country [42] 0 0
Brazil
State/province [42] 0 0
Barretos
Country [43] 0 0
Brazil
State/province [43] 0 0
Ijuí
Country [44] 0 0
Brazil
State/province [44] 0 0
Natal
Country [45] 0 0
Brazil
State/province [45] 0 0
Porto Alegre
Country [46] 0 0
Brazil
State/province [46] 0 0
Rio De Janeiro
Country [47] 0 0
Brazil
State/province [47] 0 0
Santo André
Country [48] 0 0
Brazil
State/province [48] 0 0
São José Do Rio Preto
Country [49] 0 0
Brazil
State/province [49] 0 0
São Paulo
Country [50] 0 0
Canada
State/province [50] 0 0
London
Country [51] 0 0
Canada
State/province [51] 0 0
Montreal
Country [52] 0 0
Canada
State/province [52] 0 0
Québec
Country [53] 0 0
Canada
State/province [53] 0 0
Toronto
Country [54] 0 0
China
State/province [54] 0 0
Beijing
Country [55] 0 0
China
State/province [55] 0 0
Changchun
Country [56] 0 0
China
State/province [56] 0 0
Changsha
Country [57] 0 0
China
State/province [57] 0 0
Chengdu
Country [58] 0 0
China
State/province [58] 0 0
Fuzhou
Country [59] 0 0
China
State/province [59] 0 0
Guangdong
Country [60] 0 0
China
State/province [60] 0 0
Hangzhou
Country [61] 0 0
China
State/province [61] 0 0
Harbin
Country [62] 0 0
China
State/province [62] 0 0
Nanning
Country [63] 0 0
China
State/province [63] 0 0
Shandong
Country [64] 0 0
China
State/province [64] 0 0
Shanghai
Country [65] 0 0
China
State/province [65] 0 0
Shantou
Country [66] 0 0
China
State/province [66] 0 0
Shenyang
Country [67] 0 0
China
State/province [67] 0 0
Tianjin
Country [68] 0 0
China
State/province [68] 0 0
Wuhan
Country [69] 0 0
China
State/province [69] 0 0
Zhengzhou
Country [70] 0 0
Czechia
State/province [70] 0 0
Hradec Králové
Country [71] 0 0
Czechia
State/province [71] 0 0
Ostrava-Poruba
Country [72] 0 0
Czechia
State/province [72] 0 0
Prague
Country [73] 0 0
Czechia
State/province [73] 0 0
Zlín
Country [74] 0 0
France
State/province [74] 0 0
Amiens
Country [75] 0 0
France
State/province [75] 0 0
Angers
Country [76] 0 0
France
State/province [76] 0 0
Avignon Cedex 9
Country [77] 0 0
France
State/province [77] 0 0
Bordeaux
Country [78] 0 0
France
State/province [78] 0 0
Brest
Country [79] 0 0
France
State/province [79] 0 0
Clermont Ferrand
Country [80] 0 0
France
State/province [80] 0 0
Grenoble Cedex 9
Country [81] 0 0
France
State/province [81] 0 0
le Havre
Country [82] 0 0
France
State/province [82] 0 0
Le Mans
Country [83] 0 0
France
State/province [83] 0 0
Libourne
Country [84] 0 0
France
State/province [84] 0 0
Lille
Country [85] 0 0
France
State/province [85] 0 0
Lorient
Country [86] 0 0
France
State/province [86] 0 0
Lyon
Country [87] 0 0
France
State/province [87] 0 0
Marseille
Country [88] 0 0
France
State/province [88] 0 0
Montbeliard
Country [89] 0 0
France
State/province [89] 0 0
Montpellier
Country [90] 0 0
France
State/province [90] 0 0
Nantes Cedex 2
Country [91] 0 0
France
State/province [91] 0 0
Neuilly sur Seine
Country [92] 0 0
France
State/province [92] 0 0
Nice
Country [93] 0 0
France
State/province [93] 0 0
Nimes
Country [94] 0 0
France
State/province [94] 0 0
Paris
Country [95] 0 0
France
State/province [95] 0 0
Rennes Cedex
Country [96] 0 0
France
State/province [96] 0 0
Rouen Cedex
Country [97] 0 0
France
State/province [97] 0 0
Saint Gregoire
Country [98] 0 0
France
State/province [98] 0 0
Saint Herblain
Country [99] 0 0
France
State/province [99] 0 0
Strasbourg
Country [100] 0 0
France
State/province [100] 0 0
Toulouse
Country [101] 0 0
France
State/province [101] 0 0
Tours
Country [102] 0 0
France
State/province [102] 0 0
Vandoeuvre les Nancy
Country [103] 0 0
France
State/province [103] 0 0
Villejuif
Country [104] 0 0
Georgia
State/province [104] 0 0
Kutaisi
Country [105] 0 0
Georgia
State/province [105] 0 0
Tbilisi
Country [106] 0 0
Germany
State/province [106] 0 0
Berlin
Country [107] 0 0
Germany
State/province [107] 0 0
Erlangen
Country [108] 0 0
Germany
State/province [108] 0 0
Essen
Country [109] 0 0
Germany
State/province [109] 0 0
Hamburg
Country [110] 0 0
Germany
State/province [110] 0 0
Kiel
Country [111] 0 0
Germany
State/province [111] 0 0
Leipzig
Country [112] 0 0
Germany
State/province [112] 0 0
Mannheim
Country [113] 0 0
Germany
State/province [113] 0 0
Regensburg
Country [114] 0 0
Germany
State/province [114] 0 0
Rostock
Country [115] 0 0
Greece
State/province [115] 0 0
Athens
Country [116] 0 0
Greece
State/province [116] 0 0
Thessaloníki
Country [117] 0 0
Hungary
State/province [117] 0 0
Budapest
Country [118] 0 0
Hungary
State/province [118] 0 0
Gyor
Country [119] 0 0
Hungary
State/province [119] 0 0
Pécs
Country [120] 0 0
Hungary
State/province [120] 0 0
Szeged
Country [121] 0 0
Israel
State/province [121] 0 0
Haifa
Country [122] 0 0
Israel
State/province [122] 0 0
Jerusalem
Country [123] 0 0
Israel
State/province [123] 0 0
Petach Tiqva
Country [124] 0 0
Israel
State/province [124] 0 0
Ramat Gan
Country [125] 0 0
Italy
State/province [125] 0 0
Aviano
Country [126] 0 0
Italy
State/province [126] 0 0
Brescia
Country [127] 0 0
Italy
State/province [127] 0 0
Candiolo
Country [128] 0 0
Italy
State/province [128] 0 0
Cuneo
Country [129] 0 0
Italy
State/province [129] 0 0
Firenze
Country [130] 0 0
Italy
State/province [130] 0 0
Genova
Country [131] 0 0
Italy
State/province [131] 0 0
Lecce
Country [132] 0 0
Italy
State/province [132] 0 0
Livorno
Country [133] 0 0
Italy
State/province [133] 0 0
Meldola
Country [134] 0 0
Italy
State/province [134] 0 0
Milan
Country [135] 0 0
Italy
State/province [135] 0 0
Modena
Country [136] 0 0
Italy
State/province [136] 0 0
Napoli
Country [137] 0 0
Italy
State/province [137] 0 0
Padova
Country [138] 0 0
Italy
State/province [138] 0 0
Parma
Country [139] 0 0
Italy
State/province [139] 0 0
Rome
Country [140] 0 0
Italy
State/province [140] 0 0
Savona
Country [141] 0 0
Japan
State/province [141] 0 0
Chiba
Country [142] 0 0
Japan
State/province [142] 0 0
Chuo-ku Tokyo
Country [143] 0 0
Japan
State/province [143] 0 0
Hidaka
Country [144] 0 0
Japan
State/province [144] 0 0
Hyogo
Country [145] 0 0
Japan
State/province [145] 0 0
Kamigyo-ku
Country [146] 0 0
Japan
State/province [146] 0 0
Kanagawa
Country [147] 0 0
Japan
State/province [147] 0 0
Kita-Ku
Country [148] 0 0
Japan
State/province [148] 0 0
Kita-ku
Country [149] 0 0
Japan
State/province [149] 0 0
Kobe
Country [150] 0 0
Japan
State/province [150] 0 0
Koto-ku
Country [151] 0 0
Japan
State/province [151] 0 0
Matsuyama
Country [152] 0 0
Japan
State/province [152] 0 0
Nagaizumi-cho
Country [153] 0 0
Japan
State/province [153] 0 0
Osaka
Country [154] 0 0
Japan
State/province [154] 0 0
Tokyo
Country [155] 0 0
Korea, Republic of
State/province [155] 0 0
Busan
Country [156] 0 0
Korea, Republic of
State/province [156] 0 0
Goyang-si
Country [157] 0 0
Korea, Republic of
State/province [157] 0 0
Seoul
Country [158] 0 0
Korea, Republic of
State/province [158] 0 0
Yangsan
Country [159] 0 0
Poland
State/province [159] 0 0
Gdansk
Country [160] 0 0
Poland
State/province [160] 0 0
Gdynia
Country [161] 0 0
Poland
State/province [161] 0 0
Gliwice
Country [162] 0 0
Poland
State/province [162] 0 0
Olsztyn
Country [163] 0 0
Poland
State/province [163] 0 0
Lódz
Country [164] 0 0
Portugal
State/province [164] 0 0
Braga
Country [165] 0 0
Portugal
State/province [165] 0 0
Coimbra
Country [166] 0 0
Portugal
State/province [166] 0 0
Faro
Country [167] 0 0
Portugal
State/province [167] 0 0
Lissabon
Country [168] 0 0
Portugal
State/province [168] 0 0
Porto
Country [169] 0 0
Russian Federation
State/province [169] 0 0
Kazan
Country [170] 0 0
Russian Federation
State/province [170] 0 0
Krasnoyarsk
Country [171] 0 0
Russian Federation
State/province [171] 0 0
Kursk
Country [172] 0 0
Russian Federation
State/province [172] 0 0
Moscow
Country [173] 0 0
Russian Federation
State/province [173] 0 0
Saint Petersburg
Country [174] 0 0
Russian Federation
State/province [174] 0 0
Saint-Petersburg
Country [175] 0 0
Russian Federation
State/province [175] 0 0
Ufa
Country [176] 0 0
Russian Federation
State/province [176] 0 0
Yaroslavl
Country [177] 0 0
Spain
State/province [177] 0 0
Galicia
Country [178] 0 0
Spain
State/province [178] 0 0
A Coruna
Country [179] 0 0
Spain
State/province [179] 0 0
Barcelona
Country [180] 0 0
Spain
State/province [180] 0 0
Cordoba
Country [181] 0 0
Spain
State/province [181] 0 0
Girona
Country [182] 0 0
Spain
State/province [182] 0 0
Las Palmas de Gran Canaria
Country [183] 0 0
Spain
State/province [183] 0 0
Madrid
Country [184] 0 0
Spain
State/province [184] 0 0
Manresa
Country [185] 0 0
Spain
State/province [185] 0 0
Málaga
Country [186] 0 0
Spain
State/province [186] 0 0
Pamplona
Country [187] 0 0
Spain
State/province [187] 0 0
Santander
Country [188] 0 0
Spain
State/province [188] 0 0
Valencia
Country [189] 0 0
Switzerland
State/province [189] 0 0
Bern
Country [190] 0 0
Switzerland
State/province [190] 0 0
Geneve
Country [191] 0 0
Switzerland
State/province [191] 0 0
Lausanne
Country [192] 0 0
Taiwan
State/province [192] 0 0
Kaohsiung City
Country [193] 0 0
Taiwan
State/province [193] 0 0
Kaohsiung
Country [194] 0 0
Taiwan
State/province [194] 0 0
Taichung City
Country [195] 0 0
Taiwan
State/province [195] 0 0
Taichung
Country [196] 0 0
Taiwan
State/province [196] 0 0
Taipei
Country [197] 0 0
Taiwan
State/province [197] 0 0
Taoyuan City
Country [198] 0 0
Ukraine
State/province [198] 0 0
Khodosivka
Country [199] 0 0
Ukraine
State/province [199] 0 0
Kiev
Country [200] 0 0
Ukraine
State/province [200] 0 0
Kyiv
Country [201] 0 0
United Kingdom
State/province [201] 0 0
Aberdeen
Country [202] 0 0
United Kingdom
State/province [202] 0 0
Chelsea
Country [203] 0 0
United Kingdom
State/province [203] 0 0
Glasgow
Country [204] 0 0
United Kingdom
State/province [204] 0 0
Guildford
Country [205] 0 0
United Kingdom
State/province [205] 0 0
London
Country [206] 0 0
United Kingdom
State/province [206] 0 0
Manchester
Country [207] 0 0
United Kingdom
State/province [207] 0 0
Northwood
Country [208] 0 0
United Kingdom
State/province [208] 0 0
Nottingham
Country [209] 0 0
United Kingdom
State/province [209] 0 0
Southampton
Country [210] 0 0
United Kingdom
State/province [210] 0 0
Sutton
Country [211] 0 0
United Kingdom
State/province [211] 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
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT04459715
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04459715