RP1

BIOLOGICAL4 trials

Sponsors

Replimune Inc., Sherrif Ibrahim

Conditions

Advanced Cutaneous Squamous Cell CarcinomaAdvanced MelanomaCutaneous MelanomaCutaneous Squamous Cell CarcinomaMetastatic Cutaneous Squamous Cell CarcinomaMicrosatellite Instability-High (MSI-H)Non-Small Cell Lung Cancer (NSCLC)Non-melanoma Skin Cancer (NMSC)

Phase 1

Neo-adjuvant Treatment for Squamous Cell Carcinoma Using Direct Tumor Injection With RP1.

Active, not recruitingNCT05858229

Sherrif IbrahimRP1, Squamous Cell Carcinoma

Start: 2023-06-16End: 2026-06-30Target: 12Updated: 2025-12-31

Phase 2

Study of RP1 Monotherapy and RP1 in Combination With Nivolumab (IGNYTE)

Active, not recruitingNCT03767348

Replimune Inc.Cutaneous Melanoma, Microsatellite Instability-High (MSI-H), Non-melanoma Skin Cancer (NMSC) +1

Start: 2017-09-20End: 2028-12-01Target: 340Updated: 2026-02-13

Study Evaluating Cemiplimab Alone and Combined With RP1 in Treating Advanced Squamous Skin Cancer

Active, not recruitingNCT04050436

Replimune Inc.Advanced Cutaneous Squamous Cell Carcinoma, Cutaneous Squamous Cell Carcinoma, Metastatic Cutaneous Squamous Cell Carcinoma

Start: 2019-10-08End: 2025-09-30Updated: 2025-01-27

Unknown Phase

An Expanded Access Program for VO (RP1) in Combination With Nivolumab in Patients With Advanced Melanoma

Replimune Inc.Advanced Melanoma

Updated: 2025-12-18

Related Papers

A 3-year landmark overall survival analysis of RP1 plus nivolumab in patients with anti–PD-1–failed melanoma from the IGNYTE clinical trial.

Journal of Clinical Oncology2026-05-28

A randomized, controlled, multicenter, phase 3 study of RP1 (vusolimogene oderparepvec) combined with nivolumab vs physician’s choice of therapy in patients with advanced melanoma that has progressed on anti–PD-1 and anti–CTLA-4 therapy (IGNYTE-3).

Journal of Clinical Oncology2026-05-28

Safety and feasibility of intratumoral injection of RP1 or RP2 oncolytic immunotherapies in visceral metastases.

Journal of Clinical Oncology2026-05-27

Response analysis for injected and non-injected lesions and of the safety and efficacy of superficial and deep/visceral RP1 injection in the registrational cohort of anti–PD-1–failed melanoma patients of the IGNYTE trial.

Journal of Clinical Oncology2025-05-28

Biosafety analysis from the skin cancer cohorts in the IGNYTE clinical trial of RP1.

Journal of Clinical Oncology2025-05-28

A randomized, controlled, multicenter, phase 3 study of vusolimogene oderparepvec combined with nivolumab vs treatment of physician’s choice in patients with advanced melanoma that has progressed on anti–PD-1 and anti–CTLA-4 therapy (IGNYTE-3).

Journal of Clinical Oncology2025-05-28

Onkolytische Viren zur Verstärkung der PD‐1‐Hemmung bei metastasierendem kutanem Plattenepithelkarzinom

JDDG Journal der Deutschen Dermatologischen Gesellschaft2024-07-01

Efficacy and safety of RP1 combined with nivolumab in patients with anti–PD-1–failed melanoma from the IGNYTE clinical trial.

Journal of Clinical Oncology2024-06-0118 citations

705 Biodistribution and shedding analysis following RP1 oncolytic immunotherapy dosing in patients from the IGNYTE clinical trial

Regular and Young Investigator Award Abstracts2023-10-31

Initial efficacy and safety of RP1 + nivolumab in patients with anti–PD-1–failed melanoma from the ongoing phase 1/2 IGNYTE study.

Journal of Clinical Oncology2023-06-0117 citations

610 Immune biomarker analysis of RP1 in combination with nivolumab in patients with advanced solid tumors

Regular and Young Investigator Award Abstracts2022-11-012 citations

611 Biodistribution and shedding analysis following treatment with RP1 oncolytic immunotherapy in the skin cancer patients from the IGNYTE clinical trial

Regular and Young Investigator Award Abstracts2022-11-011 citations

575 Safety and feasibility of intratumoral injection of the RPx family of oncolytic immunotherapies in patients with liver metastasis

Regular and Young Investigator Award Abstracts2022-11-01

Updated results from the skin cancer cohorts from an ongoing phase 1/2 multicohort study of RP1, an enhanced potency oncolytic HSV, combined with nivolumab (IGNYTE).

Journal of Clinical Oncology2022-06-0119 citations

A randomized, controlled, open-label, phase 2 study of cemiplimab ± RP1 in patients with advanced cutaneous squamous cell carcinoma (CERPASS).

Journal of Clinical Oncology2022-06-013 citations

547 CERPASS: A randomized, controlled, open-label, phase 2 study of cemiplimab ± RP1 in patients with advanced cutaneous squamous cell carcinoma

Regular and Young Investigator Award Abstracts2021-11-011 citations

506 IGNYTE: an open-label, multicenter, phase 1/2 (Ph 1/2) clinical trial of RP1 ± nivolumab in patients with advanced solid tumors

Regular and Young Investigator Award Abstracts2021-11-01

Abstract LB180: Clinical biomarker studies with two fusion-enhanced versions of oncolytic HSV (RP1 and RP2) alone and in combination with nivolumab in cancer patients indicate potent immune activation

Cancer Research2021-07-013 citations

422 An open-label, multicenter, phase 1/2 clinical trial of RP1, an enhanced potency oncolytic HSV, combined with nivolumab: updated results from the skin cancer cohorts

Regular and Young Investigator Award Abstracts2020-11-0113 citations

An open-label, single-arm, phase II clinical trial of RP1, an enhanced potency oncolytic herpes virus, combined with nivolumab in four solid tumor types: Initial results from the skin cancer cohorts.

Journal of Clinical Oncology2020-05-2019 citations

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