Safety and efficacy results from an open-label phase 1b/2 study of RP1 oncolytic immunotherapy in solid organ transplant recipients with advanced cutaneous malignancies (ARTACUS)
Background: Skin cancers are the most common post-transplant malignancies in solid organ transplant (SOT) recipients.While immune checkpoint inhibitors have improved outcomes in patients (pts) with advanced skin cancers, their use in transplant recipients is associated with a high risk of allograft rejection, limiting their utility in this pt population.RP1 (vusolimogene oderparepvec) is an HSV-1-based oncolytic immunotherapy expressing a fusogenic protein (GALV-GP-R-) and granulocyte-macrophage colony-stimulating factor.This study is assessing the safety and efficacy of single-agent RP1 in SOT recipients with skin cancer.Methods: The study (NCT04349436) will enroll 65 SOT recipients with histologically confirmed advanced cutaneous squamous cell carcinoma (CSCC) and 10 pts with advanced non-CSCC skin cancer in 2 parts.Part A (completed) enrolled kidney and liver transplant recipients until safety was established; Part B is enrolling
Authors
- M.R. Migden
- Meenal Kheterpal (ORCID: https://orcid.org/0000-0002-0460-6400)
- Theresa Michelle Medina (ORCID: https://orcid.org/0000-0003-0579-4121)
- Emily S. Ruiz (ORCID: https://orcid.org/0000-0001-5824-2721)
- D. Davar
- Nikhil I. Khushalani (ORCID: https://orcid.org/0000-0002-3636-4143)
- Trisha M. Wise‐Draper (ORCID: https://orcid.org/0000-0002-7279-4028)
- Wanxing Chai‐Ho (ORCID: https://orcid.org/0000-0002-0657-836X)
- Jennifer Tang (ORCID: https://orcid.org/0000-0001-9491-5022)
- Sheriff Ibrahim
- Praveen K. Bommareddy (ORCID: https://orcid.org/0000-0003-0089-8693)
- Katy K. Tsai
- Diana Bolotin
- Claire F. Verschraegen (ORCID: https://orcid.org/0000-0001-6544-3089)
- Michael Cho (ORCID: https://orcid.org/0000-0002-8191-8045)
- Soohyung Park (ORCID: https://orcid.org/0000-0001-8463-2002)
- Jundi Hou (ORCID: https://orcid.org/0000-0003-1911-9776)
- Nathalie C. Zeitouni
Institutions
- Brigham and Women's Hospital (US)
- Adobe Systems (United States) (US)
- The University of Texas MD Anderson Cancer Center (US)
- University of Arizona (US)
- University of California, Los Angeles (US)
- University of California, San Francisco (US)
- Victor (Japan) (JP)
- Moffitt Cancer Center (US)
- University of California San Diego (US)
- University of Chicago (US)
- Duke Medical Center (US)
- UPMC Hillman Cancer Center (US)
- University of Colorado Cancer Center (US)
- Sylvester Comprehensive Cancer Center (US)
- UCSF Helen Diller Family Comprehensive Cancer Center (US)
- The Ohio State University (US)
- University of Cincinnati (US)
- University of Colorado Denver (US)
Publication Details
- Journal
- EJC Skin Cancer
- Published
- 2025-01-01
- DOI
- https://doi.org/10.1016/j.ejcskn.2025.100699
- Primary Topic
- CAR-T cell therapy research
- Type
- article
- Field-Weighted Citation Impact
- 0.00