Clinical trial • Not applicable • Oncology

VUSOLIMOGENE ODERPAREPVEC for Metastatic melanoma | Advanced solid tumors | Hepatocellular carcinoma | Melanoma

Not applicable trial of VUSOLIMOGENE ODERPAREPVEC for Metastatic melanoma | Advanced solid tumors | Hepatocellular carcinoma | Melanoma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Metastatic melanoma | Advanced solid tumors | Hepatocellular carcinoma | Melanoma
Trial Stage
Not applicable
Drug Modality
Other

Key dates

Initial CTIS Submission Date
07-10-2025
First CTIS Authorization Date
09-02-2026

Trial design

None/Not specified-controlled Not applicable trial across 15 sites in France, Germany, Greece and others.

Comparator
None/Not specified
Target Sample Size
35
Trial Duration For Participant
1976

Eligibility

Recruits 35 The study states: "Patient or patient’s legal guardian has provided signed informed consent (or assent), which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol." Vulnerable population was not selected as a study population but the protocol allows consent by the patient's legal guardian and assent where applicable..

Vulnerable Population
The study states: "Patient or patient’s legal guardian has provided signed informed consent (or assent), which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol." Vulnerable population was not selected as a study population but the protocol allows consent by the patient's legal guardian and assent where applicable.

Inclusion criteria

  • {"criterion_text":"- Patient has received at least 1 dose of an RPx product and has completed or discontinued participation in the parent study.\n- Patient or patient’s legal guardian has provided signed informed consent (or assent), which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol."}

Exclusion criteria

  • {"criterion_text":"- Cannot comply with the requirements of the study."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Evaluation of delayed adverse event(s) will be based on the occurrence of: New malignancy(ies); New incidence or exacerbation of a pre-existing neurologic disorder​; New incidence or exacerbation of a pre-existing rheumatologic or other autoimmune disorder; New incidence of a hematologic disorder; New incidence of infection related to RPx​\n- New herpetic infection and presence of RPx detected in samples collected from herpetic lesions","definition_or_measurement_approach":"Endpoint 1: Defined by occurrence of the listed conditions (new malignancies; new incidence or exacerbation of pre-existing neurologic, rheumatologic/autoimmune, hematologic disorders; new incidence of infection related to RPx). Endpoint 2: Detection of new herpetic infection and laboratory detection of RPx in samples collected from herpetic lesions."}

Recruitment

Planned Sample Size
35
Recruitment Window Months
64
Consent Approach
Consent required: "Patient or patient’s legal guardian has provided signed informed consent (or assent), which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol." Subject information and ICF documents (L1_SIS and ICF_main) are provided in the application per Member State (documents listed for France, Germany, Greece, Spain, Poland).

Geography

Total Number Of Sites
15
Total Number Of Participants
41

France

Earliest CTIS Part Ii Submission Date
04-12-2025
Latest Decision Or Authorization Date
09-02-2026
Processing Time Days
67
Number Of Sites
3
Number Of Participants
13

Sites

Site Name
Centre Leon Berard
Department Name
Oncologie Médicale
Contact Person Name
Neidhardt Eve-Marie
Site Name
Institut Des Neurosciences De La Timone
Department Name
Dermatologie et Vénérologie
Contact Person Name
Gaudy-Marqueste Caroline
Contact Person Email
aroline.gaudy@ap-hm.fr
Site Name
Institut Gustave Roussy
Department Name
Dermatologie
Contact Person Name
Robert Caroline

Germany

Earliest CTIS Part Ii Submission Date
09-12-2025
Latest Decision Or Authorization Date
11-02-2026
Processing Time Days
64
Number Of Sites
2
Number Of Participants
3

Sites

Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
National Centre for Tumour Diseases (NCT)
Contact Person Name
Jessica Hassel
Site Name
LMU Klinikum Muenchen AöR
Department Name
Klinik und Poliklinik für Dermatologie und Allergologie
Contact Person Name
Lucie Heinzerling

Greece

Earliest CTIS Part Ii Submission Date
22-10-2025
Latest Decision Or Authorization Date
11-02-2026
Processing Time Days
112
Number Of Sites
3
Number Of Participants
14

Sites

Site Name
Andreas Syngros Hospital Of Venereal And Dermatological Diseases
Department Name
Dermatology-Venereology
Contact Person Name
Alexandros Stratigos
Contact Person Email
alstrat2@gmail.com
Site Name
Laiko General Hospital Of Athens
Department Name
Internal Medicine
Contact Person Name
Helen Gogas
Contact Person Email
helgogas@gmail.com
Site Name
Hippokration Hospital
Department Name
Oncology
Contact Person Name
Foteini Matsiakou
Contact Person Email
matsiakou.f@gmail.com

Spain

Earliest CTIS Part Ii Submission Date
22-10-2025
Latest Decision Or Authorization Date
16-02-2026
Processing Time Days
117
Number Of Sites
4
Number Of Participants
6

Sites

Site Name
Hospital Clinico Universitario De Valencia
Department Name
Oncology
Contact Person Name
Andres Cervantes
Contact Person Email
andres.cervantes@uv.es
Site Name
Hospital Clinic De Barcelona
Department Name
Oncology
Contact Person Name
Ana Arance Fernández
Contact Person Email
amarance@clinic.cat
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Contact Person Name
Elena Garralda Cabanas
Contact Person Email
egarralda@vhio.net
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncology
Contact Person Name
Guillermo Antonio de Velasco Oria de Rueda
Contact Person Email
gdevelasco.gdv@gmail.com

Poland

Earliest CTIS Part Ii Submission Date
12-01-2026
Latest Decision Or Authorization Date
16-02-2026
Processing Time Days
35
Number Of Sites
3
Number Of Participants
5

Sites

Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Oncology
Contact Person Name
Agata Salek-Zan
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Oncology
Contact Person Name
Piotr Rutkowski
Contact Person Email
piotr.rutkowski@nio.gov.pl
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Oncology
Contact Person Name
Kamil Drucis
Contact Person Email
kamil.drucis@gmail.com

Sponsor

Primary sponsor

Full Name
Replimune Group Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
KCR S.A.
Responsibilities
sponsorDuties codes: 1, 12, 5, 6, 7

Third parties

  • {"country":"Poland","full_name":"KCR S.A.","duties_or_roles":"sponsorDuties codes: 1, 12, 5, 6, 7","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Vusolimogene oderparepvec (RP1)
Active Substance
VUSOLIMOGENE ODERPAREPVEC
Modality
Other
Routes Of Administration
INTRATUMORAL USE
Route
INTRATUMORAL USE
Authorisation Status
Authorised (prodAuthStatus=1)
Maximum Dose
Max total dose amount 160000000 PFU/ml; max daily dose 10000000 PFU/ml
Investigational Product Name
RP2
Active Substance
RP2
Modality
Other
Routes Of Administration
INTRATUMORAL USE
Route
INTRATUMORAL USE
Authorisation Status
Authorised (prodAuthStatus=1)
Maximum Dose
Max total dose amount 151000000 PFU/ml; max daily dose 10000000 PFU/ml
Investigational Product Name
RP3
Active Substance
RP3
Modality
Other
Routes Of Administration
INTRATUMORAL USE
Route
INTRATUMORAL USE
Authorisation Status
Authorised (prodAuthStatus=1)
Maximum Dose
Max total dose amount 151000000 PFU/ml; max daily dose 10000000 PFU/ml

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