NCT05068453

Study of Oncolytic Virus in Combination With HX-008 and Radiotherapy in Melanoma Patients With Liver Metastasis

Safety and Efficacy Study of Oncolytic Virus（Intratumoral Injection）in Combination With HX-008（Intravenous Injection）and Radiotherapy for Liver Metastasis in Melanoma Patients With Liver Metastasis Who Lack or Become Refractory to Standard Treatment

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Peking University Cancer Hospital & Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Malignant melanoma, is a kind of malignant tumor derived from melanocytes. It is common in skin, mucous membrane, eye choroid and other parts. Melanoma is one of the fastest growing malignant tumors with an annual incidence rate of 3-5%. In 2012, there were 232000 new cases of melanoma and 55000 deaths worldwide. Though, the incidence rate of melanoma is relatively low in China, it has been increasing rapidly in recent years. Melanoma has seriously endangering the health of Chinese people. Patients with stage Ⅳ melanoma have a poor prognosis. According to statistics, the median survival time of stage M1a melanoma is 15 months, while stage M1b is 8 months. The median survival time of bone metastasis melanoma is 6 months, while liver and brain metastasis is 4 months. The overall median survival time of metastatic melanoma is only 7.5 months, and the 2-year survival rate is 15%. For patients with advanced melanoma, dacarbazine is the only chemotherapy drug approved by NMPA, but its overall effective rate is only 13.4%, and the median survival time is 5.6 \~ 11 months. Therapies(new drugs or new combination treatments)with higher remission rate and longer survival are urgently needed for patients with advanced melanoma.

Detailed description

This study is a single-center, single-arm,open-label study to evaluate safety and efficacy of recombinant human GM-CSF herpes simplex virus（intratumoral injection） in combination with recombinant humanized anti-PD-1 monoclonal antibody (intravenous injection) and radiotherapy for liver metastasis in stage IV melanoma. This study is planned to enroll 15-30 patients with stage IV liver metastasis melanoma who lack or become refractory to standard treatment. This study set scientific inclusion/exclusion criteria. Patients could be included in the group for treatment only after being strictly reviewed by researcher. The clinical research associate(CRA) will regularly monitor the research data during the whole study.

Conditions

• Melanoma Stage IV

Interventions

Type	Name	Description
DRUG	Recombinant Oncolytic HSV-2 Therapeutic Injecta (Vero Cell) for Human Use (rHSV2hGM-CSF)	OH2：less than 8mL/time，Q2W，i.t.；
DRUG	Recombinant humanized anti-PD-1 monoclonal antibody for injection	HX-008：200mg/time，Q3W，i.v.；
RADIATION	RT	3 times radiation，totally 24-30 Gy for each lession.

Timeline

• Start date: 2021-10-01
• Primary completion: 2023-10-31
• Completion: 2023-12-31
• First posted: 2021-10-05
• Last updated: 2021-10-05