Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ongoing, recruiting
Participants planned
118
Countries
2
Sites
13
Newly diagnosed, stage III or IV amenable to surgery, HPV negative, squamous-cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx (SCCHN) for patients who have completed and a documented complete response to gross total resection of the primary tumor and standard adjuvant therapy.
Key facts
- Sponsor
- Transgene
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 12 Dec 2019 → ongoing
- Decision date (initial)
- 2023-12-06
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-508561-33-00
- EudraCT number
- 2018-003267-58
- ClinicalTrials.gov
- NCT03839524
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Newly diagnosed, stage III or IV amenable to surgery, HPV negative, squamous-cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx (SCCHN) for patients who have completed and a documented complete response to gross total resection of the primary tumor and standard adjuvant therapy.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | PT | 10060121 | Squamous cell carcinoma of head and neck | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Transgene
- Sponsor organisation
- Transgene
- Address
- Parc D Innovation, 400 Boulevard Gonthier D Andernach, Cs 80166 Illkirch Graffenstaden, Illkirch Graffenstaden 400 Boulevard Gonthier D Andernach Cs 80166 Illkirch Graffenstaden
- City
- Illkirch Cedex
- Postcode
- 67405
- Country
- France
Scientific contact point
- Organisation
- Transgene
- Contact name
- Julien Romanetto
Public contact point
- Organisation
- Transgene
- Contact name
- Julien Romanetto
Locations
2 EU/EEA countries · 13 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 80 | 6 |
| Spain | Ongoing, recruiting | 18 | 7 |
| Rest of world
United States, United Kingdom
|
— | 20 | — |
Investigational sites
Centre Leon Berard
69, 28 Rue Laennec, 69008, Lyon
Institut Curie
75, 26 Rue D Ulm, 75005, Paris
Institut Des Neurosciences De La Timone
13, 27 Boulevard Jean Moulin, 13005, Marseille
CHU De Bordeauxt
33, 1 Rue Jean Burguet, Cs 11261, Bordeaux Cedex
Institut Universitaire Du Cancer Toulouse-Oncopole
31, 1 Avenue Irene Joliot Curie, 31100, Toulouse
Institut Gustave Roussy
94, 114 Rue Edouard Vaillant, 94800, Villejuif
Hospital Universitario Regional De Malaga
Oncology, Avenida De Carlos De Haya Sn, 29010, Malaga
Complexo Hospitalario Universitario De Santiago
Oncology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Clinico San Carlos
Oncology, Calle Del Profesor Martin Lagos Sn, 28040, Madrid
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario La Paz
Oncology, Paseo De La Castellana 261, 28046, Madrid
Hospital Universitario Virgen De La Victoria
Oncology, Campus De Teatinos Sn, Puerto De La Torre, Malaga
Institut Catala D'oncologia
Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
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 |
|---|---|---|---|---|---|
| France | 2019-12-12 | 2019-12-12 | |||
| Spain | 2025-01-15 | 2025-01-15 |
Application history
17 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-13 | France | Acceptable 2023-11-08
|
2023-12-06 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-01-11 | France | Acceptable 2023-11-08
|
2024-01-11 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-01-31 | France | Acceptable 2024-03-29
|
2024-03-29 |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2024-05-17 | Acceptable 2024-03-29
|
2024-08-12 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-05-17 | France | Acceptable 2024-03-29
|
2024-05-17 |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-09-20 | France | Acceptable 2024-12-06
|
2024-12-06 |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-12-20 | France | Acceptable 2025-03-18
|
2025-03-19 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-04-11 | France | Acceptable 2025-03-18
|
2025-04-11 |
| 9 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-05-13 | Acceptable | 2025-06-13 | |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-06-16 | France | 2025-06-16 | |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2025-07-01 | France | 2025-07-01 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-07-31 | France | Acceptable 2025-09-10
|
2025-09-11 |
| 13 | SUBSTANTIAL MODIFICATION | SM-7 | 2026-01-05 | France | Acceptable | 2026-02-05 |
| 14 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2026-02-25 | France | Acceptable | 2026-02-25 |
| 15 | SUBSTANTIAL MODIFICATION | SM-8 | 2026-03-26 | Acceptable | 2026-04-27 | |
| 16 | NON SUBSTANTIAL MODIFICATION | NSM-8 | 2026-05-18 | France | Acceptable | 2026-05-18 |
| 17 | NON SUBSTANTIAL MODIFICATION | NSM-9 | 2026-05-19 | France | Acceptable | 2026-05-19 |