Neo-adjuvant T-VEC + Nivolumab Combination Therapy for Resectable Early Metastatic (stage IIIB/C/D-IV M1a) Melanoma with Injectable Disease

PHASE2CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

September 8, 2020

Primary Completion Date

April 9, 2023

Study Completion Date

January 29, 2025

Conditions
Melanoma Stage IIIMelanoma Stage IV
Interventions
DRUG

T-VEC

The treatment schedule is based on 4 courses of intralesional T-VEC and 3 courses of intraveneous Nivolumab. T-VEC first, in order to achieve the best synergistic effect with influx of CD8+ T-cells prior to the first Nivolumab dose. T-VEC monotherapy with the dose 10\^8 PFU/mL is given every 2 weeks after 3 weeks of the first T-VEC dose (with the first dose of T-VEC 10\^6 PFU/mL to allow for seroconversion), and Nivolumab will be given every 2 weeks.

Trial Locations (1)

1066CX

Antoni van Leeuwenhoek ziekenhuis, Amsterdam

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Amgen

INDUSTRY

lead

The Netherlands Cancer Institute

OTHER

NCT04330430 - Neo-adjuvant T-VEC + Nivolumab Combination Therapy for Resectable Early Metastatic (stage IIIB/C/D-IV M1a) Melanoma with Injectable Disease | Biotech Hunter | Biotech Hunter