Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ended
Participants planned
24
Countries
1
Sites
2
reduced risk of relapse of HPV-related oropharyngeal squamous cell carcinoma
Key facts
- Sponsor
- Institut Gustave Roussy
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04], Diseases [C] - Otorhinolaryngologic Diseases [C09]
- Trial duration
- 31 Jul 2023 → 27 Mar 2026
- Decision date (initial)
- 2023-07-18
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
reduced risk of relapse of HPV-related oropharyngeal squamous cell carcinoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 22.0 | LLT | 10082410 | Human papilloma virus positive oropharyngeal squamous cell carcinoma | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Institut Gustave Roussy
- Sponsor organisation
- Institut Gustave Roussy
- Address
- 114 Rue Edouard Vaillant
- City
- Villejuif
- Postcode
- 94800
- Country
- France
Scientific contact point
- Organisation
- Institut Gustave Roussy
- Contact name
- regulatory affair officer
Public contact point
- Organisation
- Institut Gustave Roussy
- Contact name
- regulatory affair officer
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 24 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
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 | 2023-07-31 | 2026-03-27 | 2023-07-31 | 2025-03-28 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-02-01 | France | Acceptable 2023-05-22
|
2023-07-18 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-09-15 | France | Acceptable 2023-10-30
|
2023-11-06 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-03-07 | France | Acceptable 2024-04-22
|
2024-04-29 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-06-05 | France | Acceptable 2024-04-22
|
2024-06-05 |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-07-09 | France | Acceptable 2024-08-05
|
2024-08-09 |
| 6 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-02-19 | France | Acceptable 2025-03-12
|
2025-03-12 |
| 7 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-08-29 | France | Acceptable 2025-10-08
|
2025-10-08 |