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Intralesional rose bengal for treatment of melanoma.
Background: Intralesional rose bengal (PV-10) is an investigational small molecule ablative immunotherapy that can elicit primary ablation of injected tumors and 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. Methods: 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 or Stage IIIC recurrent, satellite or in-transit 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 information: NCT02288897
Abstracts by Sanjiv S. Agarwala:
Phase Ib trial of superoxide (SO) dismutase (SOD) mimetic GC4419 to reduce chemoradiotherapy (CRT)-induced oral mucositis (OM) in patients (pts) with oral cavity or oropharyngeal carcinoma (OCC).Meeting: 2016 ASCO Annual Meeting | Abstract No: 10120
Preliminary results from phase II study of combination treatment with HF10, a replication-competent HSV-1 oncolytic virus, and ipilimumab in patients with stage IIIb, IIIc, or IV unresectable or metastatic melanoma.Meeting: 2016 ASCO Annual Meeting | Abstract No: 9543Category: Melanoma/Skin Cancers - Advanced Disease
Presentations by Sanjiv S. Agarwala:
Randomized phase III trial of high-dose interferon alfa-2b (HDI) for 4 weeks induction only in patients with intermediate- and high-risk melanoma (Intergroup trial E 1697) .Meeting: 2011 ASCO Annual Meeting Abstract No: 8505Session: Melanoma/Skin Cancers (Oral Abstract Session)