Clinical Trials Logo

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05068453
Study type Interventional
Source Beijing Cancer Hospital
Contact Jun Guo, MD
Phone 86-10-88121122
Email [email protected]
Status Not yet recruiting
Phase Phase 1
Start date October 1, 2021
Completion date December 31, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT04330430 - Neo-adjuvant T-VEC + Nivolumab Combination Therapy for Resectable Early Metastatic (Stage IIIB/C/D-IV M1a) Melanoma With Injectable Disease Phase 2
Withdrawn NCT04007588 - A Phase II Trial of Neoadjuvant Treatment With PD-1 Inhibition (Nivolumab) With or Without IDO Inhibition (BMS-986205) and With or Without CTLA-4 Inhibition (Ipilimumab) in Resectable Stage III or IV Melanoma Phase 2
Recruiting NCT03620019 - Denosumab + PD-1 in Subjects With Stage III/ IV Melanoma Phase 2
Recruiting NCT04562129 - IL2 With Ipilimumab Followed by Nivolumab in Stage 3 or 4 Melanoma Patients Phase 2
Recruiting NCT04045691 - Binimetinib Plus Encorafenib Real Life Investigation of Next Generation Melanoma Treatment
Not yet recruiting NCT05070221 - Study of Oncolytic Virus in Combination With HX-008 and Axitinib in Melanoma Patients With Liver Metastasis Phase 1
Recruiting NCT03353402 - Fecal Microbiota Transplantation (FMT) in Metastatic Melanoma Patients Who Failed Immunotherapy Phase 1
Recruiting NCT04513028 - Beta Glucan's Effect on Pembrolizumab Immunologic Response in Stage III-IV Melanoma N/A
Recruiting NCT04598009 - Binimetinib and Imatinib for Unresectable Stage III-IV KIT-Mutant Melanoma Phase 2
Recruiting NCT04521075 - A Phase Ib Trial to Evaluate the Safety and Efficacy of FMT and Nivolumab in Subjects With Metastatic or Inoperable Melanoma, MSI-H, dMMR or NSCLC Phase 1/Phase 2
Completed NCT03153085 - A Study of Combination With TBI-1401(HF10) and Ipilimumab in Japanese Patients With Unresectable or Metastatic Melanoma Phase 2
Recruiting NCT04741997 - Adjuvant Therapy Based on Pathologic Response After Neoadjuvant Encorafenib Binimetinib in Melanoma Early Phase 1
Recruiting NCT03991130 - High Dose IL-2 in Combination With Anti-PD-1 to Overcome Anti-PD-1 Resistance in Metastatic Melanoma and Renal Cell Carcinoma Phase 2
Recruiting NCT04526899 - Trial With BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Anti-PD1-refractory/Relapsed, Unresectable Stage III or IV Melanoma Phase 2
Recruiting NCT04904120 - Targeted Imaging of Melanoma for Alpha-Particle Radiotherapy Phase 1
Recruiting NCT04242329 - Surgery of Melanoma Metastases After Systemic Therapy Phase 2
Recruiting NCT03161431 - SX-682 Treatment in Subjects With Metastatic Melanoma Concurrently Treated With Pembrolizumab Phase 1
Recruiting NCT04410445 - Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence Phase 3
Recruiting NCT04455503 - Study of Adjuvant Immunotherapy With EVX-02 and Anti-PD-1 Phase 1/Phase 2
Recruiting NCT04154163 - Appropriate Dosing to Optimise Personalised Cancer Treatments