Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
648
Countries
12
Sites
88
Resected squamous cell carcinoma of the head and neck
1. The purpose of this study is to demonstrate improvement in DiseaseFree Survival (DFS) with xevinapant compared to placebo when added to RT irrespective of subsequent anticancer therapy.
Key facts
- Sponsor
- Merck Healthcare KGaA
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 16 Dec 2022 → 28 Aug 2024
- Decision date (initial)
- 2024-02-26
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Merck Healthcare KGaA
External identifiers
- EU CT number
- 2023-508528-36-00
- EudraCT number
- 2022-001144-18
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
1. The purpose of this study is to demonstrate improvement in DiseaseFree Survival (DFS) with xevinapant compared to placebo when added to RT irrespective of subsequent anticancer therapy.
Conditions and MedDRA coding
Resected squamous cell carcinoma of the head and neck
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Phase III xevinapant and radiotherapy in resected LA SCCHN Phase III xevinapant and radiotherapy in resected LA SCCHN
|
Randomised Controlled | Double | [{"id":74114,"code":2,"name":"Investigator"},{"id":74113,"code":1,"name":"Subject"},{"id":74111,"code":3,"name":"Monitor"},{"id":74112,"code":5,"name":"Carer"}] | Arm A: Xevinapant (Debio 1143) + IMRT: Drug: Xevinapant (Debio 1143) Participants will receive 3 cycles of oral solution of Xevinapant (Debio 1143) at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3- week cycle in combination with radiotherapy followed by 3 cycles of monotherapy of Xevinapant (Debio 1143) at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (Each cycle is of 3 weeks). Radiation: IMRT Participants will receive 66 Gy of intensity modulated radiation therapy (IMRT) in 33 fractions, 2 y/fraction, 5 days/week. Arm B: Placebo + IMRT: Radiation: IMRT Participants will receive 66 Gy of intensity modulated radiation therapy (IMRT) in 33 fractions, 2 Gy/fraction, 5 days/week. Drug: Placebo Participants will receive 3 cycles of oral solution of placebo matched to Xevinapant (Debio 1143) once daily from Day 1 to 14 per 3-week cycle in combination with radiotherapy followed by 3 cycles of monotherapy of placebo matched to Xevinapant (Debio 1143) from Day 1 to 14, per 3-week cycle (Each cycle is of 3 weeks). |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- Participants with Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2 and able to tolerate standard of care IMRT treatment according to Investigator assessment
- Participants with histologically confirmed squamous cell carcinoma with one of the following primary sites: oral cavity, oropharynx, hypopharynx or larynx. Participants have received surgery with curative intent on these sites in the past 4 to 10 weeks before start of treatment (Cycle 1 Day 1)
- Oropharynx (OPC) participants must have known human papillomavirus (HPV) status as determined by p16 expression using immunohistochemistry ICH)
- Participants with no residual disease by computed tomography (CT) or magnetic resonance imaging (MRI) and have a high risk of relapse with 1 or 2 of the following criteria, confirmed by local histopathology:
- nodal extra-capsular extension (ECE) and positive resection margins (R1 or close margin less than or equal to (<=) 1 millimeter (mm)
- Are unfit to receive high-dose cisplatin by meeting one or more of the following criteria: estimated glomerular filtration rate (eGFR) < 60 milliliter per minute per 1.73 meter square (mL/min /1.73 m^2);History of hearing impairment, defined as Grade >= 2 audiometric hearing loss or tinnitus Grade >=2. An audiogram is not required if one of the other criteria meets unfitness to receive high-dose cisplatin; Peripheral neuropathy > = Grade 2 and if >= 70 years, unfit according to G8 questionnaire (Score <= 14) or ineligible for cisplatin treatment due to age limit according to national guidelines.
- "Participants with adequate hematologic, renal and hepatic function as defined in the protocol"
- Other protocol-defined inclusion criteria could apply
Exclusion criteria 9
- Any condition, including any uncontrolled disease state other than SCCHN that in the Investigator's opinion constitutes an inappropriate risk or a contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation
- Participant with incomplete surgery
- Primary tumor of nasopharyngeal, paranasal sinuses, nasal cavity, salivary, thyroid or parathyroid gland, skin or unknown primary site
- Prior definitive, neoadjuvant, concurrent or adjuvant (C)RT to the head and neck region which may jeopardize the primary tumor irradiation plan,or any other prior SCCHN systemic treatment, including investigational agents
- Participation in any interventional clinical study within 28 days prior to screening or during participation in this study
- Known contraindication to undergoing positron emission tomography with 18F-FDG-PET-CT scans, or both contrast-enhanced MRI and contrast enhanced CT scans
- Known allergy to Xevinapant (Debio 1143) or any excipient known to be present in Xevinapant (Debio 1143) or in the placebo formulation
- Participants with recurrent or metastatic disease
- Other protocol-defined exclusion criteria could apply
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Disease-Free Survival (DFS)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10233281 · Product
- Active substance
- Xevinapant
- Substance synonyms
- C08012907-N, DEBIO 1143, (5S,8S,10AR)-N-(DIPHENYLMETHYL)-5-((2S)-2-(METHYLAMINO)PROPANAMIDO)-3-(3-METHYLBUTANOYL)-6-OXODECAHYDROPYRROLO(1,2-A)(1,5)DIAZOCINE-8-CARBOXAMIDE, (5S,8S,10AR)-N-(DIPHENYLMETHYL)DECAHYDRO-5-(((2S)-2-(METHYLAMINO)-1-OXOPROPYL)AMINO)-3-(3-METHYL-1-OXOBUTYL)-6-OXOPYRROLO(1,2-A)(1,5)DIAZOCINE-8-CARBOXAMIDE, (5S,8S,10AR)-N-BENZHYDRYL-5-((S)-2-(METHYLAMINO)PROPANAMIDO)-3-(3-METHYLBUTANOYL)-6-OXODECAHYDROPYRROLO[1,2-A][1,5]DIAZOCINE-8-CARBOXAMIDE, DEBIO-1143, AT-406
- Other product name
- Debio 1143
- Pharmaceutical form
- ORAL SOLUTION
- Route of administration
- ORAL USE
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 3600 mg milligram(s)
- Max treatment duration
- 18 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- MERCK HEALTHCARE KGAA
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Merck Healthcare KGaA
- Sponsor organisation
- Merck Healthcare KGaA
- Address
- Frankfurter Strasse 250
- City
- Darmstadt
- Postcode
- 64293
- Country
- Germany
Scientific contact point
- Organisation
- Merck Healthcare KGaA
- Contact name
- Communication Center Merck KGaA
Public contact point
- Organisation
- Merck Healthcare KGaA
- Contact name
- Communication Center Merck KGaA
Third parties 6
| Organisation | City, country | Duties |
|---|---|---|
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring, Code 10, Code 12, Code 2, Interactive response technologies (IRT), Data management, E-data capture, Code 8, Code 9 |
| IQVIA RDS Hellas Single Member S.A. ORG-100048380
|
Chalandri, Greece | On site monitoring, Code 12, Code 5, Code 8 |
| Radialogica LLC ORG-100048281
|
Saint Louis, United States | Other |
| Inivata Limited ORG-100046830
|
Cambridge, United Kingdom | Other |
| Q Squared Solutions Limited ORG-100042527
|
Livingston, United Kingdom | Other, Laboratory analysis |
| Q Squared Solutions LLC ORG-100043195
|
Durham, United States | Other |
Locations
12 EU/EEA countries · 88 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ended | 10 | 5 |
| Belgium | Ended | 11 | 4 |
| Czechia | Ended | 9 | 3 |
| France | Ended | 86 | 25 |
| Germany | Ended | 18 | 7 |
| Greece | Ended | 8 | 3 |
| Italy | Ended | 37 | 15 |
| Netherlands | Ended | 9 | 3 |
| Poland | Ended | 7 | 1 |
| Portugal | Ended | 11 | 4 |
| Romania | Ended | 17 | 5 |
| Spain | Ended | 39 | 13 |
| Rest of world
Japan, Korea, Republic of, Switzerland, Brazil, United States, China, Turkey, United Kingdom, Canada, Georgia, India, Israel, Mexico, Argentina, Taiwan
|
— | 386 | — |
Investigational sites
Medical University Of Graz
General Otolaryngology-Head&Neck Surgery, Neue Stiftingtalstrasse 6, 8010, Graz
Ordensklinikum Linz GmbH
Department of ENT, Head and Neck Surgery, Seilerstaette 4, 4010, Linz
Klinikum Klagenfurt Am Woerthersee
Department of Otorhinolaryngology, Feschnigstrasse 11, Klagenfurt,09.Bez.:Annabichl, Klagenfurt Am Woerthersee
Medical University of Vienna
Department of Medicine I, Division of Oncology, Waehringer Guertel 18-20, Alsergrund, Vienna
SCRI CCCIT Ges.m.b.H.
3rd Medical Dept with Hematology, Medical Oncology, Hemostaseology, Infectious Diseases and Rheumato, Muellner Hauptstrasse 48, 5020, Salzburg
Antwerp University Hospital
Oncology, Drie Eikenstraat 655, 2650, Edegem
Vitaz
Oncology, Moerlandstraat 1, 9100, Sint-Niklaas
Institut Jules Bordet
Oncology, Mijlenmeersstraat 90, 1070, Anderlecht
Cliniques Universitaires Saint-Luc
Oncology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Fakultni Nemocnice Kralovske Vinohrady
Departmen of Radiotherapy and Oncology, Srobarova 1150/50, Vinohrady, Prague 10
University Hospital Olomouc
Department of Oncology, Zdravotniku 248/7, 779 00, Olomouc
Fakultni Nemocnice Bulovka
Institute of Radiation Oncology, Budinova 67/2, Liben, Prague
Institut De Cancerologie De L Ouest
Oncologie Médicale, Bd Du Professeur Jacques Monod, 44800, St Herblain
Hospices Civils De Lyon
Oncologie Radiothérapie, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
Institut De Cancerologie Strasbourg Europe
Oncologie Médicale, 17 Rue Albert Calmette, 67200, Strasbourg
Centre Oscar Lambret
Radiothérapie, 3 Rue Frederic Combemale, 59000, Lille
Centr Georges Francois Leclerc
Oncologie Radiothérapie, 1 Rue Professeur Marion, 21000, Dijon
Institut Regional Du Cancer De Montpellier
Radiotherapie oncologique, 208 Avenue Des Apothicaires, 34298, Montpellier Cedex 5
Centre Hospitalier Regional Universitaire De Tours
Oncologie medicale, 2 Boulevard Tonnelle, 37044, Tours Cedex 9
Centre Hospitalier Universitaire De Poitiers
Oncologie Médicale, 2 Rue De La Miletrie, 86000, Poitiers
Hopital Tenon
radiologie et imagerie medicale, 4 Rue De La Chine, 75970, Paris Cedex 20
Institut Gustave Roussy
Oncologie medicale, 114 Rue Edouard Vaillant, 94800, Villejuif
Institut Curie
Oncologic radiotherapy, 26 Rue D Ulm, 75005, Paris
Centre Henri Becquerel
Radiothérapie, Rue D Amiens, 76038, Rouen Cedex
Clinique Victor Hugo
Oncologie medicale, Centre De Cancerologie De La Sarthe, 66 Rue De Degre, Le Mans
Centre Francois Baclesse
Radiotherapie, 3 Avenue Du General Harris, Cs 45026, Caen Cedex 5
Centre Antoine Lacassagne
Oncologie Médicale, 33 Avenue De Valombrose, 06189, Nice Cedex 2
Groupe Hospitalier Bretagne Sud
Radiothérapie, 5 Avenue Etienne Francois De Choiseul, 56100, Lorient
Centre azureen de cancerologie
Radiothérapie, 1 Place Du Docteur Jean Luc Broquerie, 06250, Mougins
Institut Universitaire Du Cancer Toulouse-Oncopole
Radiotherapie, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Centre Hospitalier Prive Saint-Gregoire
Cancerologie, 6 Boulevard De La Boutiere, Cs 56816, Saint-Gregoire
Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer
Onco-hematologie, 54 Rue Henri Sainte Claire Deville, 83100, Toulon
Institut De Cancerologie De L Ouest
Oncologie médicale, 15 Rue Andre Boquel, 49100, Angers
Assistance Publique Hopitaux De Marseille
"Oncologie Médicale Hématologie & Soins Palliatifs", 264 Rue Saint Pierre, 13005, Marseille
Centre Hospitalier Universitaire De Bordeaux
Oncologie Médicale, 1 Rue Jean Burguet, 33000, Bordeaux
Hopital Prive Drome-Ardeche
Oncologie, 294 Boulevard Charles De Gaulle, 07500, Guilherand-Granges
Centre Hospitalier Regional Et Universitaire De Brest
Oncologie médicale, Boulevard Tanguy Prigent, 29200, Brest
Universitaetsklinikum Giessen und Marburg GmbH
Internistische Onkologie, Hämatologie, Palliativmedizin und Visceralmedizin, Abteilung Hämatologie, Klinikstrasse 33, 35392, Giessen
Vivantes Netzwerk fuer Gesundheit GmbH
Hematology, Oncology, Rudower Strasse 48, Buckow, Berlin
Rostock University Medical Center
Klinik und Poliklinik für Strahlentherapie, Nr. 05, Suedring 75, Rostock
Universitaet Leipzig
Klinik fuer Strahlentherapie und Radioonkologie, Stephanstrasse 9a, Zentrum-Suedost, Leipzig
Universitaetsklinikum Jena KöR
Department of Otorhinology, head and neck surgery, Am Klinikum 1, Lobeda, Jena
Universitaetsmedizin Goettingen
Klinik für Nephrologie und Rheumatologie, Robert-Koch-Strasse 40, Weende, Goettingen
Universitaetsklinikum Schleswig-Holstein AöR
Klinik Für Strahlenterapie, Arnold-Heller-Strasse 3, Brunswik, Kiel
Thoracic General Hospital Of Athens I Sotiria
Oncology Unit, 3rd Department of Medicine, Messogion Avenue 152, 115 27, Athens
University General Hospital Attikon
2nd Department of Internal Medicine-Propaedeutic, Rimini Street 1, 124 62, Athens
Athens Medical Center S.A.
Oncology, Pylea, Asklipiou 10, Thessaloniki
ARNAS G. Brotzu
Divisione di Oncologia Medica II, Piazzale Alessandro Ricchi 1, 09121, Cagliari
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
UOC Radioterapia, Piazzale Spedali Civili 1, 25123, Brescia
Fondazione IRCCS Istituto Nazionale Dei Tumori
S.S. Tumori della Testa e del Collo, Via Giacomo Venezian 1, 20133, Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC Radioterapia 1, Largo Francesco Vito 1, 00168, Rome
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS
Div. di Oncologia Medica ed Ematologia, Strada Provinciale 142 Km 3,95, 10060, Candiolo
Careggi University Hospital
S.O.D. di Oncologia Medica, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Oncologia, Via Sergio Pansini 5, 80131, Naples
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
U. Operativa di Immunoterapia e Terapia Cellulare, Via Piero Maroncelli 40, 47014, Meldola
Humanitas Research Hospital
Oncologia Medica ed Ematologia, Via Alessandro Manzoni 56, 20089, Rozzano
European Institute Of Oncology S.r.l.
Divisione Oncologia Medica, Via Giuseppe Ripamonti 435, 20141, Milan
Istituto Oncologico Veneto
Oncologia Medica 2, Via Gattamelata 64, 35128, Padova
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Dipartimento di Ematologia, Oncologia e Dermatologia - UOC di Oncologia Medica A, Viale Del Policlinico 155, 00161, Rome
Azienda Ospedaliero Universitaria Di Modena
UO Oncologia Medica, Largo Del Pozzo 71, 41124, Modena
Ospedale San Raffaele S.r.l.
U.O. di Oncologia Medica, Via Olgettina 60, 20132, Milan
IRCCS Istituto Nazionale Tumori Fondazione Pascale
S.C. Oncologia Clinica Sperimentale Testa-Collo e Muscolo-Scheletrica, Via Mariano Semmola 52, 80131, Naples
Universitair Medisch Centrum Utrecht
Radiology, Heidelberglaan 100, 3584 CX, Utrecht
Universitair Medisch Centrum Groningen
Oncology, Hanzeplein 1, 9713 GZ, Groningen
Amsterdam UMC
Oncology, De Boelelaan 1117, 1081 HV, Amsterdam
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Zakład Medycyny Nuklearnej i Endokrynologii Onkologicznej, Ul. Wybrzeze Armii Krajowej 15, 44-102, Gliwice
CCAB Centro Clinico Academico Braga Associacao
Oncology, Lugar De Sete Fontes S Victor, 4710-243, Braga
Centro Hospitalar De Vila Nova De Gaia/Espinho E.P.E.
Oncology, Rua Conceicao Fernandes S/n, 4434-502, Vila Nova De Gaia
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Oncology, Rua Dr. Antonio Bernardino De Almeida, 4200-072, Porto
Centro Hospitalar Universitario Sao Joao E.P.E.
Oncology, Alameda Professor Hernani Monteiro, 4200-319, Porto
Medisprof S.R.L.
Oncology, Bulevardul Muncii 96, 400641, Cluj-Napoca
Focus Lab Plus S.R.L.
Oncology, Strada Petre Negulescu 30 Section 2, 077190, Bucharest
Centrul De Oncologie SF Nectarie S.R.L.
Oncology, Strada Caracal Nr 109, 200542, Craiova
Radiotherapy Center Cluj S.R.L.
Oncology, Str. Razoare Nr. 486g Jud. Cluj, 407280, Floresti
Oncocenter Oncologie Clinica S.R.L.
Oncology, Strada Garii 1a, 300166, Timisoara
Hospital Universitario Lucus Augusti
Oncology, Rua Dr. Ulises Romero 1, 27003, Lugo
Hospital Universitari Vall D Hebron
Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Clinic De Barcelona
Oncology, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Del Mar
Oncology, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Hospital Germans Trias I Pujol
Oncology, Carretera Canyet 1a Planta, 08916, Badalona
University Hospital Virgen Del Rocio S.L.
Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Complejo Hospitalario Universitario Insular Materno Infantil
Oncology, Autovia Del Sur S/n, 35017, Las Palmas De Gran Canaria
Hospital Universitario La Paz
Oncology, Paseo Castellana 261, 28046, Madrid
Clinica Universidad De Navarra
Oncology, Calle Marquesado De Santa Marta 1, 28027, Madrid
Complexo Hospitalario Universitario A Coruna
Oncology, Lugar Jubias De Arriba 84, 15006, A Coruna
Institut Catala D'oncologia
Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitario Regional De Malaga
Oncology, Avenida De Carlos De Haya Sn, 29010, Malaga
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2023-09-26 | 2024-06-24 | |||
| Belgium | 2023-03-31 | 2024-06-24 | |||
| Czechia | 2023-05-25 | 2024-06-24 | |||
| France | 2023-02-09 | 2024-08-27 | 2023-02-23 | 2024-06-24 | |
| Germany | 2023-04-05 | 2024-07-23 | 2023-05-31 | 2024-06-24 | |
| Greece | 2023-03-30 | 2024-08-08 | 2024-03-27 | 2024-06-24 | |
| Italy | 2022-12-16 | 2024-07-22 | 2023-02-24 | 2024-06-24 | |
| Netherlands | 2023-04-25 | 2024-06-24 | 2024-03-07 | 2024-06-24 | |
| Poland | 2023-05-15 | 2024-07-29 | 2023-07-31 | 2024-06-24 | |
| Portugal | 2023-07-28 | 2024-07-26 | 2023-11-08 | 2024-06-24 | |
| Romania | 2022-12-22 | 2024-07-26 | 2023-04-25 | 2024-06-24 | |
| Spain | 2023-01-27 | 2024-07-26 | 2023-05-04 | 2024-06-24 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Urgent safety measures 1 · Art. 54 CTR
Urgent safety measure US-31945
- Event date
- 2024-06-25
- Submission date
- 2024-06-28
- In response to
- OTHER
- Member states affected
- Belgium, Netherlands, Austria, Czechia, France, Germany, Greece, Italy, Portugal, Spain, Poland, Romania
- Event description
- After the IDMC meeting on 20 June 2024 for the xevinapant Trilynx study, the IDMC notified the sponsor that the study crossed the pre-defined futility boundary at the first Interim Analysis (IA). An imbalance was seen for the reported Adverse Events in the xevinapant arm compared to placebo. The sponsor subsequently made the decision to discontinue the study.
Due to the similarity in the patient population and treatment combination between the xevinapant studies, the sponsor also decided to discontinue study MS202359_0002 on 24th June 2024. - Measures taken
- • Screening and enrollment activities via the IRT system (Cenduit) were stopped. As from today, screening, enrollment and Investigational Medicine Product (IMP) assignment (Xevinpant/placebo) via the IRT system are closed.
• The investigators and sites were informed of the sponsors decision
• For patients currently in screening:
o Patients currently in screening (signed ICF) would be documented as screen failures. The investigators have been instructed to inform patients about the study discontinuation in a timely manner.
• For patients on treatment:
o Treatment with xevinapant/placebo was stopped immediately. No IMP would be dispensed to the patients with immediate effect
o The investigators has been told to contact their patient(s) by phone within the next 24 hours and instruct their patient(s) to stop the intake of xevinapant/placebo immediately.
o Per Investigator discretion patients may continue and complete IMRT treatment according to the Protocol.
• For patients in DFS or OS follow-up:
o all assessments will be discontinued, and the patients will be informed about study discontinuationby the investigators in a timely manner. "
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| Summary of Results - CSR synopsis SUM-90809
|
2025-07-18T08:24:38 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Lay Person Summary | 2025-07-18T08:24:54 | Submitted | Laypersons Summary of Results |
Documents 57 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | Lay Person Summary - Dutch | 1 |
| Laypersons summary of results (for publication) | Lay Person Summary_CZ | 1 |
| Laypersons summary of results (for publication) | Lay Person Summary_DE | 1 |
| Laypersons summary of results (for publication) | Lay Person Summary_EL | 1 |
| Laypersons summary of results (for publication) | Lay Person Summary_EN | 1 |
| Laypersons summary of results (for publication) | Lay Person Summary_ES | 1 |
| Laypersons summary of results (for publication) | Lay Person Summary_FR | 1 |
| Laypersons summary of results (for publication) | Lay Person Summary_IT | 1 |
| Laypersons summary of results (for publication) | Lay Person Summary_PL | 1 |
| Laypersons summary of results (for publication) | Lay Person Summary_PT | 1 |
| Laypersons summary of results (for publication) | Lay Person Summary_RO | 1 |
| Recruitment arrangements (for publication) | K1_PFIS_EN_2023-508528-36-00 | 1 |
| Recruitment arrangements (for publication) | K1_PFIS_EN_2023-508528-36-00_for publication | V1.0 |
| Recruitment arrangements (for publication) | K1_PFIS_EN_2023-508528-36-00_FOR PUBLICATION | V1.0 |
| Recruitment arrangements (for publication) | K2_RecruitMat_Informed Consent Guide_FR_2023-508528-36-00_for pub | V01FRA01 |
| Recruitment arrangements (for publication) | K2_RecruitMat_Patient Advocacy Letter_FR_2023-508528-36-00_for pub | V01FRA02 |
| Recruitment arrangements (for publication) | K2_RecruitMat_Patient Brochure_FR_2023-508528-36-00_for pub | V01FRA01 |
| Recruitment arrangements (for publication) | K2_RecruitMat_Patient Poster_FR_2023-508528-36-00_for publication | V01FRA01 |
| Subject information and informed consent form (for publication) | L1_ ICF_HIV_IT_ 547_ 2023-508528-36-00_REDACTED FOR PUBLICATION | V1.0ITAv1 |
| Subject information and informed consent form (for publication) | L1_ ICF_Main_FR_2023-508528-36-00_red for pub | V4.1FRA1.0 |
| Subject information and informed consent form (for publication) | L1_ ICF_Pregnancy_FR_2023-508528-36-00_Redacted for publication | V1.0FRA2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS or ICF_HIV_IT_ 2023-508528-36-00_FOR PUBLICATION | V1.0ITAv1 |
| Subject information and informed consent form (for publication) | L1_SIS or ICF Main_ES_2023-508528-36-00_FOR PUBLICATION | V4.1ESP1.0 |
| Subject information and informed consent form (for publication) | L1_SIS or ICF Optional FSR_ES_2023-508528-36-00_FOR PUBLICATION | V1.0ESP1.0 |
| Subject information and informed consent form (for publication) | L1_SIS or ICF PP_ES_2023-508528-36-00_FOR PUBLICATION | V1.0ESP2.0 |
| Subject information and informed consent form (for publication) | L1_SIS or ICF_Main_IT_ 2023-508528-36-00_REDACTED FOR PUBLICATION | V4.1ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS or ICF_Optional Future Research_IT_2023-508528-36-00_FOR PUBLICATION | V1.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS or ICF_Optional Future Research_IT_542_2023-508528-36-00_REDACTED FOR PUBLICATION | V1.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS or ICF_Optional Future Research_IT_547_2023-508528-36-00_REDACTED FOR PUBLICATION | V1.0ITAv1 |
| Subject information and informed consent form (for publication) | L1_SIS or ICF_Optional Future Research_IT_548_2023-508528-36-00_REDACTED FOR PUBLICATION | V1.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS or ICF_Optional Future Research_IT_551_2023-508528-36-00_REDACTED FOR PUBLICATION | V1.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS or ICF_Optional Future Research_IT_554_2023-508528-36-00_REDACTED FOR PUBLICATION | V1.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS or ICF_Optional Genetic Research_IT_2023-508528-36-00_REDACTED FOR PUBLICATION | V1.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS or ICF_Optional Genetic Research_IT_542_2023-508528-36-00_REDACTED FOR PUBLICATION | V1.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS or ICF_Optional Genetic Research_IT_547_2023-508528-36-00_REDACTED FOR PUBLICATION | V1.0ITAv1 |
| Subject information and informed consent form (for publication) | L1_SIS or ICF_Optional Genetic Research_IT_551_2023-508528-36-00_REDACTED FOR PUBLICATION | V1.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS or ICF_Optional Genetic Research_IT_554_2023-508528-36-00_REDACTED FOR PUBLICATION | V1.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS or ICF_PP_IT_2023-508528-36-00_FOR PUBLICATION | V1.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS or ICF_PP_IT_542_2023-508528-36-00_REDACTED FOR PUBLICATION | V1.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS or ICF_PP_IT_547_2023-508528-36-00_REDACTED FOR PUBLICATION | V1.0ITAv1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_CITELINE_EU Information Release Consent_IT_2023-508528-36-00 | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_eCOA HH_App_Screenshots_EN_FR_2023-508528-36-00_red for pub | V1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_GP letter_IT_2023-508528-36-00_FOR PUBLICATION | v4.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HHTrainingModule_Screenshots_EN_FR_2023-508528-36-00_for pub | V1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Informed Consent Guide_IT_2023-508528-36-00_FOR PUBLICATION | V01 ITA |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Advocacy Letter_IT_2023-508528-36-00_FOR PUBLICATION | V01 ITA |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Brochure_IT_2023-508528-36-00_FOR PUBLICATION | V01 ITA |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Emergency Card_FR_2023-508528-36-00_Red for pub | V01FRA01 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Emergency Card_IT_2023-508528-36-00 | V01 ITA |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Poster_IT_2023-508528-36-00_FOR PUBLICATION | V01 ITA |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Study Guide_FR_2023-508528-36-00_for pub | V01FRA01 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Study Guide_IT_2023-508528-36-00_FOR PUBLICATION | V01 ITA |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Release Consent_IT_2023-508528-36-00_REDACTED FOR PUBLICATION | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Subject Diary_IT_2023-508528-36-00_REDACTED FOR PUBLICATION | V3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Visit Reminder Card_FR_2023-508528-36-00_for pub | V01FRA01 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Visit Reminder Card_IT_2023-508528-36-00_FOR PUBLICATION | V01 ITA |
| Summary of results (for publication) | Summary of results_CSR synopsis_Redacted | 1 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-22 | Belgium | Acceptable 2024-02-20
|
2024-02-21 |
| 2 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-08-02 | Acceptable | 2024-09-10 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-08-02 | Acceptable | 2024-09-13 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-08-02 | 2024-09-16 |