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)

Squamous Cell Carcinoma of the Head and Neck Clinical Trial

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 Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04459715
• Other study ID #: MS202359_0006
• Secondary ID: 2020-000377-25De
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: August 7, 2020
• Est. completion date: April 30, 2027

Study information

• Verified date: June 2024
• Source: EMD Serono
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 730
• Est. completion date: April 30, 2027
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Squamous Cell Carcinoma of Head and Neck
• Squamous Cell Carcinoma of the Head and Neck

Intervention

Drug:
• Xevinapant (Debio 1143)
Xevinapant (Debio 1143) administrated as oral solution from Day 1 to 14, every 21-day cycle.
• Cisplatin
Cisplatin administered as an IV infusion every 3 weeks (Q3W).

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

Drug:
• Placebo
Matched placebo administrated as oral solution from Day 1 to 14, every 21-day cycle.

Locations

Country	Name	City	State
Argentina	Hospital Aleman	Buenos Aires
Argentina	Instituto Medico Especialazado Alexander Fleming	Buenos Aires
Argentina	Clinica Universitaria Reina Fabiola	Cordoba
Argentina	Instituto de Oncologia de Rosario	Santa Fe
Argentina	Clinica Viedma	Viedma
Australia	Ashford Cancer Centre Research, Tennyson Centre	Adelaide
Australia	St Vincents Hospital	Darlinghurst
Australia	St Vincents Hospital Melbourne	Fitzroy
Australia	Peter MacCallum Cancer Centre	Melbourne
Australia	Wollongong Hospital	Wollongong
Australia	Princess Alexandra Hospital, Cancer Trials Unit	Woolloongabba
Austria	Klinische Abteilung fur Allgemeine HNO Universitatsklinik fur Hals-, Nasen- und Ohrenheilkunde	Graz
Austria	Landeskrankenhaus Salzburg	Salzburg
Austria	Universitätsklinik für Innere Medizin III der PMU	Salzburg
Austria	Medical University of Vienna, Department of Medicine I, Division of Oncology	Vienna
Belgium	Cliniques universitaires Saint-Luc	Bruxelles
Belgium	Grand Hopital de Charleroi	Charleroi
Belgium	Universitair Ziekenhuis Antwerpen	Edegem
Belgium	Universitair Ziekenhuis Gent UZ Gent	Gent
Belgium	Hopital de Jolimont, Rue Ferrer	La Louvière
Belgium	UZ Leuven, Radiotherapy & Oncology	Leuven
Belgium	Centre Hospitalier de l'Ardenne (CHA)	Libramont
Belgium	CHU UCL Namur Site Sainte Elisabeth	Namur
Belgium	A.Z. Nikolaas	Sint-Niklaas
Belgium	GZA Sint-Augustinus	Wilrijk
Brazil	Fundação Pio XII- Hospital de Cancer de Barretos, Rua Antenor Duarte Vilela	Barretos
Brazil	Hospital de Caridade de Ijui, Avenida David Jose Martins	Ijuí
Brazil	Liga Norte Riograndense Contra o Câncer, Avenida Miguel Castro	Natal
Brazil	Centro Gaúcho Integrado, Rua Costa	Porto Alegre
Brazil	Hospital Santa Rita Centro de Pesquisa Clínica Novos Tratamentos Em Câncer	Porto Alegre
Brazil	Hospital Santa Rita, Centro de Pesquisa Clínica Novos Tratamentos Em Câncer	Porto Alegre
Brazil	National Cancer Institute	Rio De Janeiro
Brazil	CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia - FMABC - Faculdade de Medicina do ABC	Santo André
Brazil	Hospital de Base de Sao Jose do Rio Preto, Av. Brigadeiro Faria Lima	São José Do Rio Preto
Brazil	Instituto do Cancer do Estado de Sao Paulo (ICESP)	São Paulo
Brazil	Oswaldo Cruz German Hospital	São Paulo
Canada	London Regional Cancer Program, London Health Sciences Centre	London
Canada	CHU Montréal	Montreal
Canada	CIUSSS de l'Est de l'Ile de Montreal - Hopital Maisonneuve-Rosemont	Montreal
Canada	Hopital Maisonneuve-Rosemont	Montreal
Canada	CHU de Quebec-Université Laval	Québec
Canada	Sunnybrook Research Institute	Toronto
China	Beijing Cancer Hospital	Beijing
China	Peking Union Medical College Hospital	Beijing
China	Jilin Cancer Hospital	Changchun
China	Hunan Cancer Hospital	Changsha
China	Xiangya Hospital Central South University	Changsha
China	West China Hospital of Sichuan University	Chengdu
China	Fujian Cancer Hospital	Fuzhou
China	The 5th Affiliated Hospital of Sun yet-sen university	Guangdong
China	The 2nd Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou
China	Zhejiang Province Cancer Hospital	Hangzhou
China	Harbin Medical University Cancer Hospital	Harbin
China	Affiliated Tumor Hospital of Guangxi Medical University	Nanning
China	Lin Yi Cancer Hospital	Shandong
China	Fudan University Shanghai Cancer Center	Shanghai
China	Shanghai Ninth People's Hospital	Shanghai
China	Shantou University Cancer Hospital	Shantou
China	Liaoning Cancer Hospital & institute	Shenyang
China	Tianjin Medical University Cancer Institute & Hospital	Tianjin
China	Tongji Hospital/Tongji Medical College, Huazhong University of Science	Wuhan
China	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan
China	Henan Cancer Hospital	Zhengzhou
Czechia	University Hospital hradec Kralové	Hradec Králové
Czechia	Fakultni Nemocnice Ostrava	Ostrava-Poruba
Czechia	Hospital Na Bulovce	Prague
Czechia	KOC KNTB a.s. Zlín	Zlín
France	CHU Amiens Picardie - Hopital Sud	Amiens
France	Institut de Cancérologie de l Ouest (ICO)	Angers
France	Institut Sainte Catherine	Avignon Cedex 9
France	Centre hospitalier Universitaire de Bordeaux	Bordeaux
France	CHRU de Brest Hopital Morvan	Brest
France	Centre Jean Perrin CLCC	Clermont Ferrand
France	CHU de Grenoble	Grenoble Cedex 9
France	Centre Guillaume Le Conquerant	le Havre
France	Clinique Victor Hugo	Le Mans
France	Centre hospitalier Libourne	Libourne
France	Centre Oscar Lambret	Lille
France	Hôpital du Scorff	Lorient
France	Centre Leon Berard	Lyon
France	Service d'Oncologie Médicale, CHU Timone	Marseille
France	Hôpital Nord Franche Comté	Montbeliard
France	Institut Regional du Cancer de Montpellier	Montpellier
France	LHopital prive du Confluent Nantes	Nantes Cedex 2
France	CCConcorde (GCS)	Neuilly sur Seine
France	Centre Antoine Lacassagne	Nice
France	CHU Nimes	Nimes
France	Institut Curie	Paris
France	Centre Eugène Marquis	Rennes Cedex
France	Centre Henri Becquerel CLCC	Rouen Cedex
France	CHP Saint Gregoire FINESS	Saint Gregoire
France	Institut de Cancérologie de l'Ouest - Site Saint Herblain	Saint Herblain
France	ICANS	Strasbourg
France	Institut Claudius Regaud - IUCT-O	Toulouse
France	CHU de Tours	Tours
France	The Public Hospital L'Institut de Cancerologie de Lorraine	Vandoeuvre les Nancy
France	Institut Gustave Roussy - Service de radiotherapie	Villejuif
Georgia	Evex Hospitals Oncology Center	Kutaisi
Georgia	Academician Fridon Todua Medical Center-Ltd Research Institute of Clinical Medicine	Tbilisi
Georgia	Cancer Research Cent 4	Tbilisi
Georgia	Institute of Clinical Oncology	Tbilisi
Georgia	JSC "Evex Hospitals"	Tbilisi
Georgia	LEPL First University Clinic of Tbilisi State Medical University	Tbilisi
Georgia	New Hospitals	Tbilisi
Germany	CAMPUS CHARITÉ MITTE, Klinik f.Strahlentherapie	Berlin
Germany	Charité - Universitätsmedizin Berlin Campus Virchow	Berlin
Germany	Strahlenklinik des Uni-Klinikums	Erlangen
Germany	Department of radiation oncology, University Hospital Essen	Essen
Germany	Univesitätsklinikum Essen (AöR) Klinikum und Poliklinik für Strahlentherapie	Essen
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg
Germany	University Medical Center Schleswig-Holstein, Campus Kiel	Kiel
Germany	Universitatsklinikum Leipzig AoR, Klinik für Strahlentherapie	Leipzig
Germany	Universitaetsmedizin Mannheim UMM, Klinik fuer Hals-Nasen-Ohrenheilkunde Kopf- und Halschirurgie	Mannheim
Germany	Universitaetsklinikum Regensburg	Regensburg
Germany	Universitaetsmedizin Rostock	Rostock
Greece	Agioi Anargiroi General Oncology Hospital of Kifissia	Athens
Greece	Attikon University Hospital	Athens
Greece	Theagenio Anticancer Hospital	Thessaloníki
Hungary	Orszagos Onkologiai Intezet Sugarterapias Osztaly	Budapest
Hungary	Uzsoki Utcai Korhaz Onkologiai Osztaly	Budapest
Hungary	Petz Aladár Megyei Kórház Onkoradiológiai Osztály	Gyor
Hungary	Pecsi Tudomanyegyetem Klinikai Kozpont Onkoterapias Intazet	Pécs
Hungary	Szegedi Tudományegyetem ÁOK Onkoterápiás Klinika	Szeged
Israel	Rambam Healthcare Campus	Haifa
Israel	Research Fund of the Hadassah Medical Organization	Jerusalem
Israel	Rabin Medical Center	Petach Tiqva
Israel	Sheba Medical Center	Ramat Gan
Italy	Centro di Riferimento Oncologico	Aviano
Italy	Azienda Socio Sanitaria Territoriale (ASST) degli Spedali Civili di Brescia	Brescia
Italy	Istituto di Candiolo IRCCS	Candiolo
Italy	Azienda Sanitaria Ospedaliera Santa Croce e Carle - Oncologia Medica -Ospedale Carle	Cuneo
Italy	Azienda Ospedaliero-Universitaria Careggi	Firenze
Italy	IRCCS AOU San Martino	Genova
Italy	Ospedale "Vito Fazzi" Lecce	Lecce
Italy	Az. USL 6 Ospedali Riuniti-Ospedale di Livorno	Livorno
Italy	IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)	Meldola
Italy	IRCCS-Istituto Europeodi Oncologia The European Institute of Oncology IEO	Milan
Italy	Istituto Nazionale dei Tumori	Milan
Italy	Policlinico di Modena	Modena
Italy	AORN Ospedale dei Monaldi	Napoli
Italy	AOU "Luigi Vanvitelli"	Napoli
Italy	Istituto Nazionale Tumori (INT) IRCCS Fondazione "G. Pascale"	Napoli
Italy	Istituto Oncologico Veneto Irccs	Padova
Italy	Azienda Ospedaliero Universitaria di Parma	Parma
Italy	Fondazione Policlinico Universitario Agostino Gemelli	Rome
Italy	ASL2_Presidio Ospedaliero San Paolo	Savona
Japan	National Cancer Center Hospital East	Chiba
Japan	National Cancer Center Hospital	Chuo-ku Tokyo
Japan	Saitama Medical University International Medical Center	Hidaka
Japan	Hyogo Cancer Center	Hyogo
Japan	University Hospital Kyoto Prefectural University of Medicine	Kamigyo-ku
Japan	Tokai University Hospital	Kanagawa
Japan	Hokkaido University Hospital	Kita-Ku
Japan	Okayama University Hospital	Kita-ku
Japan	Kobe University Hospital	Kobe
Japan	Cancer Institute Hospital of JFCR	Koto-ku
Japan	National Hospital Organization Shikoku Cancer Center	Matsuyama
Japan	Shizuoka Cancer Center	Nagaizumi-cho
Japan	Osaka International Cancer Institute	Osaka
Japan	Tokyo Medical University Hospital	Tokyo
Korea, Republic of	Pusan National University Hospital	Busan
Korea, Republic of	National Cancer Center	Goyang-si
Korea, Republic of	National Cancer Center Hematologic Oncology	Goyang-si
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Asan Medical Center, Asian Cacer Center	Seoul
Korea, Republic of	KonKuk University Medical Center	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Seoul National University Boramae Medical Center	Seoul
Korea, Republic of	Pusan National University Yangsan Hospital, Oncol & Hematology	Yangsan
Poland	Uniwersyteckie Centrum Kliniczne - Klinika Onkologii i Radioterapii	Gdansk
Poland	Szpitale Pomorskie Sp. z o.o.	Gdynia
Poland	Centrum Onkologii- Instytut im. Marii Sklodowskiej-Curie Oddzial w Gliwicach	Gliwice
Poland	NZOZ Provita Prolife Centrum Medyczne	Lódz
Poland	SP ZOZ MSWiA z W-M CO w Olsztynie	Olsztyn
Portugal	Centro Clinico Academico	Braga
Portugal	Hospital de Braga	Braga
Portugal	Instituto Português de Oncologia de Coimbra Francisco Gentil, EPE	Coimbra
Portugal	Centro Hospitalar Universitário do Algarve - Hospital de Faro (PRT)	Faro
Portugal	Centro Hospitalar Universitário Lisboa Norte	Lissabon
Portugal	Centro Hospitalar de Vila Nova de Gaia/Espinho	Porto
Portugal	Centro Hospitalar Universitario São João	Porto
Portugal	Hospital Pedro Hispano	Porto
Portugal	Instituto Portugues de Oncologia Porto Francisco Gentil, E.P.E	Porto
Russian Federation	State Autonomous Healthcare Institution "Republican Clinical Oncological Dispensary of the Ministry of Healthcare of the Republic of Tatarstan"	Kazan
Russian Federation	Krasnoyarsk Regional Clinical Oncological Dispensary named after A.I.Kryzhanovsky	Krasnoyarsk
Russian Federation	Kursk Regional Clinical Oncology Dispensary	Kursk
Russian Federation	FGBU N.N.Blokhin Russian Cancer Research Center	Moscow
Russian Federation	EuroCityClinic	Saint Petersburg
Russian Federation	Saint- Petersburg Clinical Research Center of Specialized Types of Medical Care (Oncology)	Saint Petersburg
Russian Federation	FSBI National Med Research Cancer Center N.N. Petrov	Saint-Petersburg
Russian Federation	Republican Clinical Oncological Dispensary of Bashkortostan	Ufa
Russian Federation	State Budgetary Healthcare Institution Republican Clinical Oncology Dispensary (RUS)	Ufa
Russian Federation	State Budgetary Institution of Healthcare of Yaroslavl region Clinical oncology hospital	Yaroslavl
Spain	Fundacin Oncolgico de Galicia Jos Antonio Quiroga y Pieyro	A Coruna
Spain	Fundacion Centro Oncologico de Galicia (COG) "Jose Antonio Quiroga y Pineyro"	A Coruña	Galicia
Spain	Hospital Clinic Barcelona	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Institut Català d'Oncologia Badalona	Barcelona
Spain	Institut Català d'Oncologia, Hospital Duran	Barcelona
Spain	Institut Universitari Dexeus-Quiron (ESP)	Barcelona
Spain	Hospital Reina Sofía	Cordoba
Spain	Institut Català d'Oncologia	Girona
Spain	Hospital Universitario Insular de Gran Canaria	Las Palmas de Gran Canaria
Spain	Clinica Universidad de Navarra	Madrid
Spain	Hospital 12 de Octubre	Madrid
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Ramon y Cajal	Madrid
Spain	Hospital Universitario HM Sanchinarro	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Civil (Hospital Regional Universitario)	Málaga
Spain	Althaia, Xarxa Assistencial	Manresa
Spain	Fundacio Althaia	Manresa
Spain	Clinica Universidad de Navarra	Pamplona
Spain	Hospital Universitario Marqués de Valdecilla. Santander	Santander
Spain	Fundacion Investigacion Hospital General Universitario de Valencia FiHgU (ESP)	Valencia
Spain	Hospital Universitario La Fe	Valencia
Spain	IVO	Valencia
Switzerland	Inselspital, Bern University Hospital, Universitätsklinik für Radio-Onkologie	Bern
Switzerland	Hopitaux Universitaires de Geneve	Geneve
Switzerland	Centre Hospitalier Universitaire Vaudois Lausanne	Lausanne
Taiwan	Kaohsiung Medical University Memorial Hospital	Kaohsiung
Taiwan	Chang-Gung Memorial Hospital-Kaohsiung	Kaohsiung City
Taiwan	China Medical University Hospital	Taichung
Taiwan	Taichung Veterans General Hospital	Taichung City
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital (VGHTP)	Taipei
Taiwan	Chang Gung Medical Foundatoin Linkou Chang Gung Memorial Hospital	Taoyuan City
Ukraine	Medical center ASKLEPION LLC	Khodosivka
Ukraine	Kiev City Clinical Oncology Centre	Kiev
Ukraine	Medical center of Yuriy Spizhenko, Soborna Vulytsia	Kyiv
United Kingdom	Aberdeen Royal infirmary, Dept. of Oncology	Aberdeen
United Kingdom	Royal Marsden NHS Foundation Trust	Chelsea
United Kingdom	NHS Greater Glasgow and Clyde	Glasgow
United Kingdom	Royal Surrey County Hospital	Guildford
United Kingdom	Charing Cross Hospital	London
United Kingdom	The Christie NHS Foundation Trust	Manchester
United Kingdom	Mount Vernon Cancer Centre	Northwood
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham
United Kingdom	University Hospital Southampton NHS Foundation Trust	Southampton
United Kingdom	The Royal Marsden NHS Foundation Trust - Sutton	Sutton
United Kingdom	Clatterbridge Cancer Centre NHS Foundation Trust	Wirral
United States	University South Hospital	Ann Arbor	Michigan
United States	Ashland-Bellefonte Cancer Center	Ashland	Kentucky
United States	University of Colorado at Denver and Health Sciences Center	Aurora	Colorado
United States	The University of Alabama at Birmingham - Hazelrig-Salter Radiation Oncology Center (HSROC)	Birmingham	Alabama
United States	Beth Israel Deaconess (BI Lahey)/Harvard Cancer Center	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Medical University of South Carolina- Hollings Cancer Center	Charleston	South Carolina
United States	University of Virginia Medical Center	Charlottesville	Virginia
United States	University of Cincinnati Medical Center	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	University Hospital Cleveland Medical Center	Cleveland	Ohio
United States	University of Missouri - Ellis Fischel Cancer Center	Columbia	Missouri
United States	Columbus Regional Research Institute	Columbus	Georgia
United States	IACT Health, John B. Amos Cancer Center	Columbus	Georgia
United States	Ohio State University	Columbus	Ohio
United States	Henry Ford Health System	Detroit	Michigan
United States	Karmanos Cancer institute	Detroit	Michigan
United States	Inventa Center for Cancer Research At Fort Wayne Medical Oncology and Hematology	Fort Wayne	Indiana
United States	Gettysburg Cancer Center	Gettysburg	Pennsylvania
United States	Banner MD Anderson Cancer Center	Gilbert	Arizona
United States	MD Anderson	Houston	Texas
United States	MidAmerica Cancer Care	Kansas City	Missouri
United States	UC San Diego Moores Cancer Center	La Jolla	California
United States	Comprehensive Cancer Center of Nevada (Southern Hills) (USA)	Las Vegas	Nevada
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	Norton Cancer Institute, Louisville, Kentucky, Brownsboro Hospital Campus	Louisville	Kentucky
United States	NYU Langone Hospital-Long Island Oncology	Mineola	New York
United States	Yale Cancer Center	New Haven	Connecticut
United States	Laura and Isaac Perlmutter Cancer Center at NYU Langone Health	New York	New York
United States	NYU Grossman School of Medicine	New York	New York
United States	University of Oklahoma Health Sciences Center- Stephenson Cancer Center	Oklahoma City	Oklahoma
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Providence Portland Medical Center	Portland	Oregon
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	IHO Corporation/Utah Cancer Specialists	Salt Lake City	Utah
United States	Regents of the University of California	San Francisco	California
United States	UCSF	San Francisco	California
United States	Moffitt Cancer Center	Tampa	Florida
United States	University of Arizona Cancer Center	Tucson	Arizona
United States	Lombardi Comprehensive Cancer Center, Georgetown University Medical Center	Washington	District of Columbia
United States	ASCLEPES Research Centers	Weeki Wachee	Florida
United States	The Oncology Institute of Hope & Innovation	Whittier	California
United States	Wake Forest University School of Medicine	Winston-Salem	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
EMD Serono Research & Development Institute, Inc.	GORTEC (Head and Neck Oncology and Radiotherapy Group), Merck KGaA, Darmstadt, Germany

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  China,  Czechia,  France,  Georgia,  Germany,  Greece,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Poland,  Portugal,  Russian Federation,  Spain,  Switzerland,  Taiwan,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event-Free Survival (EFS)	EFS is the time from the date of randomization to the date of first record of disease progression or death.	Up to 5 years
Secondary	Overall survival (OS)	OS is the time from randomization to death due to any cause.	Up to 5 years
Secondary	Progression-Free Survival (PFS)	PFS is the time from randomization to the earliest between PFS event or End of Study (EOS)	Up to 5 years
Secondary	Locoregional Control (LRC)		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	Objective Response Rate (ORR)	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).	Up to 5 years
Secondary	Complete Response Rate (CRR)	CRR defined as proportion of participants with complete response (CR) as assessed by Blinded Independent Review Committee (BIRC).	Up to 5 years
Secondary	Duration of Response (DOR)	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.	Up to 5 years
Secondary	Number of Participants with Radical Salvage Surgery		Up to 5 years
Secondary	Time to Subsequent Systemic Cancer Treatments		Up to 5 years
Secondary	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		From signed informed consent to EOS (within 6.8 years)
Secondary	Changes from Baseline in Global Health Status/Quality of Life (GHS/QoL) and Fatigue Symptom	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)	Prior to the first dose of study treatment (Baseline) and at the time of last follow-up (Up to 5 years)
Secondary	Changes from Baseline in Swallowing and Pain Symptoms	Change from baseline in swallowing, and pain symptoms using the EORTC Head and Neck Questionnaire (EORTC QLQ-H&N35)	Prior to the first dose of study treatment (Baseline) and at the time of last follow-up (Up to 5 years)

External Links

•   Trial Awareness and Transparency website