PVSRIPO for Patients With Unresectable Melanoma

Summary

This study is a Phase I study of oncolytic polio/rhinovirus recombinant (PVSRIPO) to primarily characterize the safety and tolerability of PVSRIPO in patients with AJCC Stage IIIB, IIIC, or IV melanoma in a modified 3+3 phase 1 trial design. Lesion biopsies and blood samples will be obtained pre- and post-injection throughout the study for routine histology/molecular genetic testing and immunologic analysis, respectively. Exploratory objectives include describing the response rates of PVSRIPO-injected versus non-injected lesion(s), the number of CD8 positive T cells present in the tumor biopsies before and after injection of PVSRIPO, and after PVSRIPO administration: the pathologic response in tumor biopsies, changes in the tumor microenvironment, and how systemic immune cell populations may change.

Timeline

Start

2018-11-26

Primary completion

2021-03-23

Completion

2021-03-23

Publications

• Brown MC, Beasley GM, McKay ZP, Yang Y, Desjardins A, Randazzo DM, Landi D, Ashley DM, Bigner DD, Nair SK, Gromeier M. Intratumor childhood vaccine-specific CD4+ T-cell recall coordinates antitumor CD8+ T cells and eosinophils. J Immunother Cancer. 2023 Apr;11(4):e006463. doi: 10.1136/jitc-2022-006463.
• Beasley GM, Brown MC, Farrow NE, Landa K, Al-Rohil RN, Selim MA, Therien AD, Jung SH, Gao J, Boczkowski D, Holl EK, Salama AKS, Bigner DD, Gromeier M, Nair SK. Multimodality analysis confers a prognostic benefit of a T-cell infiltrated tumor microenvironment and peripheral immune status in patients with melanoma. J Immunother Cancer. 2022 Sep;10(9):e005052. doi: 10.1136/jitc-2022-005052.
• Beasley GM, Nair SK, Farrow NE, Landa K, Selim MA, Wiggs CA, Jung SH, Bigner DD, True Kelly A, Gromeier M, Salama AK. Phase I trial of intratumoral PVSRIPO in patients with unresectable, treatment-refractory melanoma. J Immunother Cancer. 2021 Apr;9(4):e002203. doi: 10.1136/jitc-2020-002203.

Drugs

Indications