1158TiP - Intralesional rose bengal for stage III and IV melanoma

Date 09 October 2016
Event ESMO 2016 Congress
Session Poster display
Topics Melanoma and other Skin Tumours
Presenter Sanjiv Agarwala
Citation Annals of Oncology (2016) 27 (6): 379-400. 10.1093/annonc/mdw379
Authors S.S. Agarwala1, R.H.I. Andtbacka2, A. Hauschild3, K.N. Rice4, M. Ross5, C.R. Scoggins6, M. Smithers7, E. Whitman8, E.A. Wachter9
  • 1Cancer Center, St. Luke's Hospital & Health Network, 18015 - Bethlehem/US
  • 2Surgical Oncology, Huntsman Cancer Institute, Salt Lake City/US
  • 3Department Of Dermatology, University of Kiel (UKSH), 24105 - Kiel/DE
  • 4Hematology/oncology, Sharp Memorial Hospital, San Diego/US
  • 5Surgical Oncology, MD Anderson Cancer Center, Houston/US
  • 6Surgical Oncology, University of Louisville, Louisville/US
  • 7The University Of Queensland, Princess Alexandra Hospital, Brisbane/AU
  • 8Oncology, Atlantic Melanoma Center, Morristown/US
  • 9Clinical Development, Provectus Biopharmaceuticals, Knoxville/US

Abstract

Background

Intralesional rose bengal (PV-10) is an investigational small molecule ablative immunotherapy that can elicit primary ablation of injected tumors and anti-tumor immune response via secondary T-cell activation. Phase 2 testing in Stage III-IV melanoma yielded a 51% objective response rate (ORR) with 50% complete response (CR) when all disease was injected. PV-10 is currently undergoing phase 3 testing as a single agent in patients with locally advanced cutaneous melanoma and phase 1b testing in combination with immune checkpoint inhibition for more advanced disease.

Trial design

Study PV-10-MM-31 (NCT02288897) is an international multicenter, open-label, randomized controlled trial of PV-10 versus investigator's choice of chemotherapy (dacarbazine or temozolomide) or oncolytic viral therapy (talimogene laherparepvec). A total of 225 subjects with locally advanced cutaneous melanoma (Stage IIIB, IIIC or IV-M1a melanoma) randomized 2:1 will be assessed for progression free survival (PFS) by RECIST 1.1 (using blinded Independent Review Committee assessment of study photography and radiology data). Comprehensive disease assessments, including review of photography and radiology data, are performed at 12 week intervals; clinical assessments of progression status are performed at 28-day intervals. Study PV-10-MM-1201 (NCT02557321) is an international multicenter, open-label, sequential phase study of PV-10 in combination with pembrolizumab. Stage IV metastatic melanoma patients with at least one injectable cutaneous or subcutaneous lesion who are candidates for pembrolizumab are eligible. In the current phase 1b portion of the study, up to 24 subjects will receive the combination of PV-10 and pembrolizumab (PV-10 + standard of care). In phase 2 an estimated 120 participants will be randomized 1:1 to receive either PV-10 and pembrolizumab or pembrolizumab alone. The primary endpoint for phase 1b is safety and tolerability with PFS a key secondary endpoint; PFS is the primary endpoint for phase 2.

Clinical trial identification

NCT02288897; NCT02557321

Legal entity responsible for the study

Provectus Biopharmaceuticals, Inc.

Funding

Provectus Biopharmaceuticals, Inc.

Disclosure

E.A. Wachter: Employee and shareholder of Provectus, sponsor of the subject clinical trials. All other authors have declared no conflicts of interest.