P1/2, N=50, Active, not recruiting, Provectus Biopharmaceuticals, Inc. | Recruiting --> Active, not recruiting | Phase classification: P1b/2 --> P1/2 | N=192 --> 50

6 months ago

Enrollment closed • Phase classification • Enrollment change • Combination therapy • Checkpoint inhibition • Metastases

Keytruda (pembrolizumab) • Provecta (rose bengal sodium)

over1year

PV-10-NET-01: A Phase 1 Study of PV-10 Chemoablation of Neuroendocrine Tumours (NET) Metastatic to the Liver (clinicaltrials.gov)

P1, N=12, Active, not recruiting, Provectus Biopharmaceuticals, Inc. | Trial completion date: May 2021 --> Sep 2023

over 1 year ago

Trial completion date • Metastases

SSTR (Somatostatin Receptor)

SSTR Expression

Provecta (rose bengal sodium)

over2years

PV-10 vs Chemotherapy or Oncolytic Viral Therapy for Treatment of Locally Advanced Cutaneous Melanoma (clinicaltrials.gov)

P3, N=20, Terminated, Provectus Biopharmaceuticals, Inc. | N=32 --> 20

over 2 years ago

Enrollment change • Oncolytic virus

BRAF (B-raf proto-oncogene)

BRAF V600 • BRAF wild-type

temozolomide • dacarbazine • Imlygic (talimogene laherparepvec) • Provecta (rose bengal sodium)

almost4years

[VIRTUAL] A phase Ib study of rose bengal disodium and anti-PD-1 in metastatic cutaneous melanoma: Initial results in patients refractory to checkpoint blockade (ESMO 2020)

Methods PV-10-MM-1201 (NCT02557321) is a phase 1b/2 study of IL PV-10 in combination with systemic anti-PD-1 (pembrolizumab, “pembro”) for patients (pts) with advanced cutaneous melanoma; pts must have at least 1 injectable lesion and be candidates for pembro...Funding: Provectus Biopharmaceuticals, Inc. Clinical trial identification: NCT02557321.

almost 4 years ago

Clinical • P1 data • Checkpoint inhibition

CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • HMGB1 (High Mobility Group Box 1)

Keytruda (pembrolizumab) • Provecta (rose bengal sodium)