A Study to Assess the Long-term Safety Outcomes in Patients Previously Treated With RP1, RP2, or RP3

Start 16 Mar 2026 · Status Ongoing, recruiting · 5 EU/EEA countries · 15 sites · Protocol RPL-123-01

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)

Status Ongoing, recruiting

Participants planned 76

Countries 5

Sites 15

Metastatic Melanoma

To evaluate the long-term safety of patients treated with an RPx product and identify any delayed adverse event(s) related to treatment with an RPx product

Key facts

Sponsor: Replimune Group Inc.
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Neoplasms [C04]
Trial duration: 16 Mar 2026 → ongoing
Decision date (initial): 2026-02-09
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No

External identifiers

EU CT number: 2025-521621-33-00
ClinicalTrials.gov: NCT06887348

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety

To evaluate the long-term safety of patients treated with an RPx product and identify any delayed adverse event(s) related to treatment with an RPx product

Secondary objectives 1

To identify systemic HSV-1 infection related to treatment with an RPx product

Conditions and MedDRA coding

Metastatic Melanoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

Patient has received at least 1 dose of an RPx product and has completed or discontinued participation in the parent study.
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 1

Cannot comply with the requirements of the study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

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
New herpetic infection and presence of RPx detected in samples collected from herpetic lesions

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 11

Vusolimogene oderparepvec

PRD4949048 · Product

Active substance: Vusolimogene Oderparepvec
Substance synonyms: Herpes simplex virus type 1, strain RH018A, ICP34.5 and ICP47 deleted, encoding granulocyte-macrophage colony stimulating factor and Gibbon ape leukemia virus fusogenic glycoprotein, RP1
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INTRATUMORAL USE
Max daily dose: 10000000 PFU/ml plaque forming unit(s)/millilitre
Max total dose: 160000000 PFU/ml plaque forming unit(s)/millilitre
Max treatment duration: 24 Month(s)
Authorisation status: Not Authorised
MA holder: REPLIMUNE, LTD.
Paediatric formulation: No
Orphan designation: No

Vusolimogene oderparepvec

PRD7532420 · Product

Active substance: Vusolimogene Oderparepvec
Substance synonyms: Herpes simplex virus type 1, strain RH018A, ICP34.5 and ICP47 deleted, encoding granulocyte-macrophage colony stimulating factor and Gibbon ape leukemia virus fusogenic glycoprotein, RP1
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INTRATUMORAL USE
Max daily dose: 10000000 PFU/ml plaque forming unit(s)/millilitre
Max total dose: 160000000 PFU/ml plaque forming unit(s)/millilitre
Max treatment duration: 24 Month(s)
Authorisation status: Not Authorised
MA holder: REPLIMUNE, LTD.
Paediatric formulation: No
Orphan designation: No

Vusolimogene oderparepvec

PRD4949046 · Product

Active substance: Vusolimogene Oderparepvec
Substance synonyms: Herpes simplex virus type 1, strain RH018A, ICP34.5 and ICP47 deleted, encoding granulocyte-macrophage colony stimulating factor and Gibbon ape leukemia virus fusogenic glycoprotein, RP1
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INTRATUMORAL USE
Max daily dose: 10000000 PFU/ml plaque forming unit(s)/millilitre
Max total dose: 160000000 PFU/ml plaque forming unit(s)/millilitre
Max treatment duration: 24 Month(s)
Authorisation status: Not Authorised
MA holder: REPLIMUNE, LTD.
Paediatric formulation: No
Orphan designation: No

Vusolimogene oderparepvec

PRD4949047 · Product

Active substance: Vusolimogene Oderparepvec
Substance synonyms: Herpes simplex virus type 1, strain RH018A, ICP34.5 and ICP47 deleted, encoding granulocyte-macrophage colony stimulating factor and Gibbon ape leukemia virus fusogenic glycoprotein, RP1
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INTRATUMORAL USE
Max daily dose: 10000000 PFU/ml plaque forming unit(s)/millilitre
Max total dose: 160000000 PFU/ml plaque forming unit(s)/millilitre
Max treatment duration: 24 Month(s)
Authorisation status: Not Authorised
MA holder: REPLIMUNE, LTD.
Paediatric formulation: No
Orphan designation: No

Vusolimogene oderparepvec

PRD7532419 · Product

Active substance: Vusolimogene Oderparepvec
Substance synonyms: Herpes simplex virus type 1, strain RH018A, ICP34.5 and ICP47 deleted, encoding granulocyte-macrophage colony stimulating factor and Gibbon ape leukemia virus fusogenic glycoprotein, RP1
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INTRATUMORAL USE
Max daily dose: 10000000 PFU/ml plaque forming unit(s)/millilitre
Max total dose: 160000000 PFU/ml plaque forming unit(s)/millilitre
Max treatment duration: 24 Month(s)
Authorisation status: Not Authorised
MA holder: REPLIMUNE, LTD.
Paediatric formulation: No
Orphan designation: No

RP3

PRD8407900 · Product

Active substance: RP3
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INTRATUMORAL USE
Max daily dose: 10000000 PFU/ml plaque forming unit(s)/millilitre
Max total dose: 151000000 PFU/ml plaque forming unit(s)/millilitre
Max treatment duration: 24 Month(s)
Authorisation status: Not Authorised
MA holder: REPLIMUNE, LTD.
Paediatric formulation: No
Orphan designation: No

RP3

PRD8407901 · Product

Active substance: RP3
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INTRATUMORAL USE
Max daily dose: 10000000 PFU/ml plaque forming unit(s)/millilitre
Max total dose: 151000000 PFU/ml plaque forming unit(s)/millilitre
Max treatment duration: 24 Month(s)
Authorisation status: Not Authorised
MA holder: REPLIMUNE, LTD.
Paediatric formulation: No
Orphan designation: No

RP3

PRD8407902 · Product

Active substance: RP3
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INTRATUMORAL USE
Max daily dose: 10000000 PFU/ml plaque forming unit(s)/millilitre
Max total dose: 151000000 PFU/ml plaque forming unit(s)/millilitre
Max treatment duration: 24 Month(s)
Authorisation status: Not Authorised
MA holder: REPLIMUNE, LTD.
Paediatric formulation: No
Orphan designation: No

RP2

PRD7532837 · Product

Active substance: RP2
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INTRATUMORAL USE
Max daily dose: 10000000 PFU/ml plaque forming unit(s)/millilitre
Max total dose: 151000000 PFU/ml plaque forming unit(s)/millilitre
Max treatment duration: 24 Month(s)
Authorisation status: Not Authorised
MA holder: REPLIMUNE, LTD.
Paediatric formulation: No
Orphan designation: No

RP2

PRD7532836 · Product

Active substance: RP2
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INTRATUMORAL USE
Max daily dose: 10000000 PFU/ml plaque forming unit(s)/millilitre
Max total dose: 151000000 PFU/ml plaque forming unit(s)/millilitre
Max treatment duration: 24 Month(s)
Authorisation status: Not Authorised
MA holder: REPLIMUNE, LTD.
Paediatric formulation: No
Orphan designation: No

RP2

PRD7532838 · Product

Active substance: RP2
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INTRATUMORAL USE
Max daily dose: 10000000 PFU/ml plaque forming unit(s)/millilitre
Max total dose: 151000000 PFU/ml plaque forming unit(s)/millilitre
Max treatment duration: 24 Month(s)
Authorisation status: Not Authorised
MA holder: REPLIMUNE, LTD.
Paediatric formulation: No
Orphan designation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Replimune Group Inc.

Sponsor organisation: Replimune Group Inc.
Address: 500 Unicorn Park Drive Floor Third
City: Woburn
Postcode: 01801-3377
Country: United States

Scientific contact point

Organisation: Replimune Group Inc.
Contact name: Kari Jeschke

Public contact point

Organisation: Replimune Group Inc.
Contact name: Kari Jeschke

Third parties 1

Organisation	City, country	Duties
KCR S.A. ORG-100011019	Warsaw, Poland	On site monitoring, Code 12, Code 5, Data management, E-data capture

Locations

5 EU/EEA countries · 15 investigational sites

By country

Country	MS status	Planned subjects	Sites
France	Ongoing, recruiting	13	3
Germany	Ongoing, recruiting	3	2
Greece	Authorised, recruiting	14	3
Poland	Ongoing, recruiting	5	3
Spain	Authorised, recruiting	6	4
Rest of world Australia, United States, United Kingdom	—	35	—

Investigational sites

France

3 sites · Ongoing, recruiting

Centre Leon Berard

Oncologie Médicale, 28 Rue Laennec, 69008, Lyon

Institut Des Neurosciences De La Timone

Dermatologie et Vénérologie, 27 Boulevard Jean Moulin, 13005, Marseille

Institut Gustave Roussy

Dermatologie, 114 Rue Edouard Vaillant, 94800, Villejuif

Germany

2 sites · Ongoing, recruiting

Universitaetsklinikum Heidelberg AöR

National Centre for Tumour Diseases (NCT), Im Neuenheimer Feld 460, Neuenheim, Heidelberg

LMU Klinikum Muenchen AöR

Klinik und Poliklinik für Dermatologie und Allergologie, Frauenlobstrasse 9-11, Ludwigsvorstadt-Isarvorstadt, Munich

Greece

3 sites · Authorised, recruiting

Andreas Syngros Hospital Of Venereal And Dermatological Diseases

Dermatology-Venereology, Dragoumi Ionos 5 I, 161 21, Athens

Hippokration Hospital

Oncology, Vassilissas Sofias Avenue 114, 115 27, Athens

Laiko General Hospital Of Athens

Internal Medicine, Agiou Thoma (goudi) 17, 115 27, Athens

Poland

3 sites · Ongoing, recruiting

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

Oncology, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

Oncology, Ul. Garncarska 11, 31-115, Cracow

Uniwersyteckie Centrum Kliniczne

Oncology, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk

Spain

4 sites · Authorised, recruiting

Hospital Clinic De Barcelona

Oncology, Calle Villarroel 170, 08036, Barcelona

Hospital Clinico Universitario De Valencia

Oncology, Avenida Blasco Ibanez 17, 46010, Valencia

Hospital Universitario 12 De Octubre

Oncology, Avenida De Cordoba Sn, 28041, Madrid

Hospital Universitari Vall D Hebron

Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country	Trial start	Recruitment start
France	2026-03-30	2026-05-12
Germany	2026-04-01	2026-04-30
Greece	2026-05-13
Poland	2026-03-16	2026-04-14
Spain	2026-04-14

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 28 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Type	Title	Version
Protocol (for publication)	D1_Protocol Amendment 2025-521621-33-00 Summary of Changes	1.0
Protocol (for publication)	D1_Protocol Amendment 2025-521621-33-00 Tracked Changes	1.0
Protocol (for publication)	D1_Protocol Amendment GR 2025-521621-33-00	1.0
Protocol (for publication)	D1_Protocol Amendment_2025-521621-33-00_redacted	1.0
Recruitment arrangements (for publication)	K1_Recruitment arrangements	1.0
Recruitment arrangements (for publication)	K1_Recruitment arrangements	1.0
Recruitment arrangements (for publication)	K1_Recruitment arrangements	N/A
Recruitment arrangements (for publication)	K1_Recruitment arrangements	1.0
Recruitment arrangements (for publication)	K1_Recruitment arrangements	1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Main	1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Main	1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_main	1.2
Subject information and informed consent form (for publication)	L1_SIS and ICF_main	2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_main	2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_main_tracked changes	2.0
Subject information and informed consent form (for publication)	L2_Other subject information material Patient emergency ID card	1.0
Synopsis of the protocol (for publication)	D1_Protocol Synopsis 2025-521621-33-00 Redacted	1.0
Synopsis of the protocol (for publication)	D1_Protocol Synopsis DE 2025-521621-33-00	1.0
Synopsis of the protocol (for publication)	D1_Protocol Synopsis ES 2025-521621-33-00	1.0
Synopsis of the protocol (for publication)	D1_Protocol Synopsis FR 2025-521621-33-00	1.0
Synopsis of the protocol (for publication)	D1_Protocol Synopsis GR 2025-521621-33-00	1.0
Synopsis of the protocol (for publication)	D1_Protocol Synopsis PL 2025-521621-33-00	1.0
Synopsis of the protocol (for publication)	D1_Protocol Synopsis Plain Language 2025-521621-33-00	1.0
Synopsis of the protocol (for publication)	D1_Protocol Synopsis Plain Language DE 2025-521621-33-00	1.0
Synopsis of the protocol (for publication)	D1_Protocol Synopsis Plain Language ES 2025-521621-33-00	1.0
Synopsis of the protocol (for publication)	D1_Protocol Synopsis Plain Language FR 2025-521621-33-00	1.0
Synopsis of the protocol (for publication)	D1_Protocol Synopsis Plain Language GR 2025-521621-33-00	1.0
Synopsis of the protocol (for publication)	D1_Protocol Synopsis Plain Language PL 2025-521621-33-00	1.0

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2025-10-07	Spain	Acceptable 2026-02-09	2026-02-09

A Study to Assess the Long-term Safety Outcomes in Patients Previously Treated With RP1, RP2, or RP3

Overview

Key facts

External identifiers

Trial design

Main objective

Secondary objectives 1

Conditions and MedDRA coding

Eligibility criteria

Inclusion criteria 2

Exclusion criteria 1

Endpoints

Primary endpoints 2

Investigational products

Test 11

Sponsors and contacts

Replimune Group Inc.

Scientific contact point

Public contact point

Third parties 1

Locations

By country

Investigational sites

Country notifications

Results and documents

Documents 28 files

Application history

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