Clinical trial • Phase I • Oncology

Durvalumab for Hepatocellular carcinoma

Phase I trial of Durvalumab for Hepatocellular carcinoma. 10 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Hepatocellular carcinoma
Trial Stage
Phase I
Drug Modality
Vaccine|Other|Monoclonal antibody

Key dates

Initial CTIS Submission Date
21-10-2024
First CTIS Authorization Date
11-11-2024

Trial design

Phase I trial across 1 site in Italy.

Target Sample Size
10

Recruitment

Planned Sample Size
10
Recruitment Window Months
40

Geography

Total Number Of Sites
1
Total Number Of Participants
10

Italy

Earliest CTIS Part Ii Submission Date
26-09-2024
Latest Decision Or Authorization Date
11-11-2024
Processing Time Days
46
Number Of Sites
1
Number Of Participants
10

Sites

Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
Oncologia Medica Melanoma Immunoterapia Oncologica e Terapie Innovative
Principal Investigator Name
Paolo Ascierto
Principal Investigator Email
p.ascierto@istitutotumori.na.it
Contact Person Name
Paolo Ascierto
Number Of Participants
10

Sponsor

Primary sponsor

Full Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Italy

Investigational products

Investigational Product Name
IMA970A
Modality
Vaccine
Investigational Product Name
Montanide
Modality
Other
Investigational Product Name
Durvalumab
Active Substance
Durvalumab
Modality
Monoclonal antibody
Combination Treatment
Yes

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