Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
850
Countries
3
Sites
19
Advanced PRAME Positive Cancers
Key facts
- Sponsor
- Immunocore Limited
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 7 Nov 2024 → ongoing
- Decision date (initial)
- 2024-09-12
- 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
Advanced PRAME Positive Cancers
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10025650 | Malignant melanoma | 100000004864 |
| 20.0 | PT | 10042863 | Synovial sarcoma | 100000004864 |
| 21.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
| 21.1 | PT | 10009252 | Clear cell endometrial carcinoma | 100000004864 |
| 27.0 | PT | 10008593 | Cholangiocarcinoma | 100000004864 |
| 21.1 | PT | 10041067 | Small cell lung cancer | 100000004864 |
| 20.0 | PT | 10057649 | Endometrial sarcoma | 100000004864 |
| 21.0 | PT | 10053231 | Adenoid cystic carcinoma | 100000004864 |
| 21.0 | PT | 10014733 | Endometrial cancer | 100000004864 |
| 20.0 | PT | 10033128 | Ovarian cancer | 100000004864 |
| 21.1 | PT | 10033700 | Papillary serous endometrial carcinoma | 100000004864 |
| 20.0 | PT | 10046766 | Uterine cancer | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Immunocore Limited
- Sponsor organisation
- Immunocore Limited
- Address
- 92 Park Drive, Milton Milton
- City
- Abingdon
- Postcode
- OX14 4RY
- Country
- United Kingdom
Scientific contact point
- Organisation
- Immunocore Limited
- Contact name
- Regulatory Affairs
Public contact point
- Organisation
- Immunocore Limited
- Contact name
- Information desk
Locations
3 EU/EEA countries · 19 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 160 | 7 |
| Italy | Ongoing, recruiting | 160 | 4 |
| Spain | Ongoing, recruiting | 200 | 8 |
| Rest of world
Australia, United Kingdom
|
— | 330 | — |
Investigational sites
Centre Leon Berard
Medical Oncology, 28 Rue Laennec, 69008, Lyon
Institut Gustave Roussy
Drug Development Department (DITEP), 114 Rue Edouard Vaillant, 94800, Villejuif
Institut Universitaire Du Cancer Toulouse-Oncopole
Unité de Recherche Clinique, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Institut De Cancerologie De L Ouest
Medical Oncology, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
Assistance Publique Hopitaux De Paris
Dermatology, 1 Avenue Claude Vellefaux, 75010, Paris
Centre Antoine Lacassagne
Oncology, 33 Avenue De Valombrose, 06189, Nice Cedex 2
Centre Francois Baclesse
Oncology, 3 Avenue Du General Harris, Cs 45026, Caen Cedex 5
Fondazione IRCCS Istituto Nazionale Dei Tumori
Medical Oncology and Hematology, Via Giacomo Venezian 1, 20133, Milan
Istituto Europeo Di Oncologia S.r.l.
Divisione di sviluppo nuovi farmaci per Terapie Innovative, Via Giuseppe Ripamonti 435, 20141, Milan
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Melanoma, Cancer Immunotherapy and Development Therapeutics Unit, Via Mariano Semmola 52, 80131, Naples
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Dipartimento Scienze della Salute della Donna, del Bambino e di Sanita' Pubblica, Largo Francesco Vito 1, 00168, Rome
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario Ramon Y Cajal
Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Institut Catala D'oncologia
Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Clinica Universidad De Navarra
Oncology, Calle Marquesado De Santa Marta 1, 28027, Madrid
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario 12 De Octubre
Oncology, Avenida De Cordoba Sn, 28041, Madrid
Hospital Universitario Y Politecnico La Fe
Oncology, Avenida Fernando Abril Martorell 106, 46026, Valencia
Clinica Universidad De Navarra
Oncology, Pio XII Etorbidea 36, 31008, Pamplona
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 | 2024-11-20 | 2024-11-27 | |||
| Italy | 2025-01-17 | 2025-01-20 | |||
| Spain | 2024-11-07 | 2024-11-12 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-31 | France | Acceptable 2024-09-12
|
2024-09-12 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-09-23 | France | Acceptable | 2024-10-10 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-02-21 | France | Acceptable | 2025-02-21 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-05-30 | Acceptable | 2025-05-30 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-07-16 | France | Acceptable 2025-09-04
|
2025-09-05 |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-11-28 | France | Acceptable 2026-02-20
|
2026-02-20 |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-03-13 | Acceptable | 2026-03-23 |