RecruitingPhase 3NCT05868707

OH2 Injection in Melanoma

To Evaluate a Phase III Study of OH2 Versus Investigator-selected Salvage Chemotherapy or Best Supportive Care in Melanoma Patients Who Had Failed Standard Therapy

Sponsor

Binhui Biopharmaceutical Co., Ltd.

Enrollment

340 participants

Start Date

Mar 8, 2023

Study Type

INTERVENTIONAL

Conditions

Melanoma

Summary

To evaluate the efficacy of OH2 injection in patients with unresectable or metastatic melanoma who have failed at least second-line standard therapy, using investigator-selected salvage chemotherapy or best supportive care (BSC) as controls.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an experimental treatment called OH2 — a modified virus that targets and kills cancer cells — by injecting it directly into tumours in people with advanced melanoma (a type of skin cancer) that has not responded to at least two prior treatments. **You may be eligible if...** - You are 18 or older - You have been diagnosed with stage III or stage IV melanoma confirmed by pathology - Your cancer has progressed after at least two lines of standard treatment (including immunotherapy and targeted therapy if applicable) - A reasonable percentage of your tumour cells are accessible for injection **You may NOT be eligible if...** - You have had fewer than two prior lines of standard treatment - Your cancer is only present in areas that cannot be safely injected - You have active brain metastases or certain serious medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGOH2

Oncolytic Type 2 Herpes Simplex Virus

DRUGSalvage chemotherapy or best supportive care

single or combined, including but not limited to dacarbazine, temozolomide, taxoid, or platinum

Locations(30)

Peking University Cancer Hospital

Beijing, Beijing Municipality, China

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

Fujian Cancer Hosptial

Fuzhou, Fujian, China

Dermatology Hospital of Southern Medical University

Guangzhou, Guangdong, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, China

Hainan Cancer Hospital

Haikou, Hainan, China

The Fourth Hospital of Hebei Medical University and Hebei Tumor Hospital

Shijiazhuang, Hebei, China

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

The Third People's Hospital of Zhengzhou

Zhengzhou, Henan, China

Hubei Cancer Hospital

Wuhan, Hubei, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Jilin Cancer Hospital

Changchun, Jilin, China

The first hospital of Jilin University

Changchun, Jilin, China

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Liaoning Cancer Hospital ＆ Institute

Shenyang, Liaoning, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

The Affiliated Cancer Hospital of Shandong First Medical University

Jinan, Shandong, China

Weifang People's Hospital

Weifang, Shandong, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Tianjin Medical University Cancer Institute ＆ Hospital

Tianjin, Tianjin Municipality, China

The Affiliated Cancer Hospital, Xinjiang Medical University

Ürümqi, Xinjiang, China

Yunnan Cancer Hospital

Kunming, Yunnan, China

Cancer Hospital Of The University Of Chinese Academy Of Sciences Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05868707

Related Trials

Evaluation for NCI Surgery Branch Clinical Research Protocols

NCT000018231 location

DESTINY-PANTUMOUR04

NCT0712400017 locations

A Study to Assess IPN01194 When Administered Alone in Adults With Advanced Solid Tumours

NCT0630524712 locations

Safety and Efficacy of OBX-115 in Advanced Solid Tumors

NCT060606139 locations

Novel RNA-lipid Particle (RNA-LP) Vaccine for Anti-PD-1 Antibody Therapy Sensitization

NCT052649741 location