Clinical trial • Phase III • Oncology

Tumor infiltrating lymphocytes (TIL) for Metastatic melanoma

Phase III trial of Tumor infiltrating lymphocytes (TIL) for Metastatic melanoma. 20 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Metastatic melanoma
Trial Stage
Phase III
Drug Modality
Cell therapy|Vaccine

Key dates

Initial CTIS Submission Date
15-10-2024
First CTIS Authorization Date
23-01-2025

Trial design

Phase III trial across 1 site in Sweden.

Target Sample Size
20

Eligibility

Recruits 20 Vulnerable population selected; no details on consent or assent provided..

Vulnerable Population
Vulnerable population selected; no details on consent or assent provided.

Recruitment

Planned Sample Size
20
Recruitment Window Months
180

Geography

Total Number Of Sites
1
Total Number Of Participants
20

Sweden

Earliest CTIS Part Ii Submission Date
15-10-2024
Latest Decision Or Authorization Date
23-01-2025
Processing Time Days
100
Number Of Sites
1
Number Of Participants
20

Sites

Site Name
Karolinska University Hospital
Department Name
Head, Neck, Lung and Skin Cancer
Contact Person Name
Maria Wolodarski

Sponsor

Primary sponsor

Full Name
Karolinska University Hospital
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Sweden

Investigational products

Investigational Product Name
Tumor infiltrating lymphocytes (TIL)
Modality
Cell therapy
Investigational Product Name
Dendritic cell vaccine
Modality
Vaccine
Combination Treatment
Yes

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