The phase 1 clinical trial of anti–PD-1 ab plus intrahepatic injection of oncolytic virus (OH2) combined radiotherapy of liver metastasis in stage IV melanoma
Abstract
9547
Background:
Patients with melanoma and liver metastases generally exhibit reduced responses to systemic immunotherapy. Oncolytic herpes simplex virus 2 (OH2), is an oncolytic virus with potential therapeutic benefits. Preliminary clinical trials have demonstrated the efficacy of combining PD-1 antibody therapy with intrahepatic intralesional injections of OH2. Additionally, liver metastasis radiotherapy may modulate the tumor microenvironment, potentially enhancing the efficacy of immunotherapy combinations. In this phase I study, we aim to evaluate the safety and efficacy of OH2 and Pucotenlimab, in combination with liver metastasis-directed radiotherapy in patients with melanoma.
Methods:
Eligible pts included those over 18 with injectable liver metastasis confirmed by biopsy with or without extra-hepatic metastasis; the ocular melanoma and brain metastasis were excluded. Pts received intravenous Pucotenlimab Q3W combined with ultrasound guided intrahepatic injection of OH2 Q2W (10
7
CCID50/mL, 8ml per injection) after SBRT (24-30Gy/3Fx) of liver metastasis. The primary endpoint was ORR. Clinical trial: NCT05068453.
Results:
From Dec 2021 to Jan 2025, 20 pts were enrolled. 77.8% had received at least one prior treatment; 52.9% presented with extrahepatic metastases. The median size of enrolled lesions was 34.56 mm (13.0–271.0 mm). The median number of liver metastases was 5.5. Among these patients, 17 were evaluable for efficacy. One iCR, four iPR, resulting in an ORR…
Read the paper
Related studies
- Penicillins for Treatment of Pneumococcal Pneumonia: Does In Vitro Resistance Really Matter?
- Thiophenes—Naturally Occurring Plant Metabolites: Biological Activities and In Silico Evaluation of Their Potential as Cathepsin D Inhibitors
- Inhalable Mannosylated Rifampicin–Curcumin Co-Loaded Nanomicelles with Enhanced In Vitro Antimicrobial Efficacy for an Optimized Pulmonary Tuberculosis Therapy
- Development and validation of microbial bioassay for quantification of Levofloxacin in pharmaceutical preparations
- GC-MS Analysis and Biomedical Therapy of Oil from n-Hexane Fraction of Scutellaria edelbergii Rech. f.: In Vitro, In Vivo, and In Silico Approach
- Propranolol, chlorpromazine and diclofenac restore susceptibility of extensively drug-resistant (XDR)-Acinetobacter baumannii to fluoroquinolones
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.