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

Status: Recruiting
Location: See all (30) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ Over 18 years old, male or female;

⁃ Stage III or stage IV melanoma that has been definitively diagnosed by pathology and/or cytology and has failed at least second-line standard therapy (including chemotherapy, immunotherapy, and targeted therapy for those with genetic mutations) (progression to unresectable or metastatic melanoma within 6 months after the end of adjuvant therapy or during adjuvant therapy, This adjuvant therapy can be considered as advanced first-line therapy) for patients with unresectable or metastatic melanoma;

⁃ The overall percentage of subjects with mucosal melanoma will not exceed 22%;

⁃ Eastern Oncology Consortium (ECOG) physical condition score ECOG 0 \

• 1;

⁃ The expected survival time is more than 3 months;

⁃ At least 4 weeks after completion of previous antitumor therapy (including chemotherapeutic/radiotherapy, targeted therapy, immunotherapy) (at least 2 weeks after completion of previous bone radiotherapy, at least 6 weeks after withdrawal of chemotherapy using nitrosourea and mitomycin), and have recovered from adverse reactions of previous treatment (≤ grade 1 or baseline, except hair loss), and 4 weeks after surgery for major surgery;

⁃ At least one measurable target lesion was present according to RECIST 1.1 criteria. There are lesions suitable for intratumoral injection. Measurable tumor lesions were defined as longest diameter ≥10 mm and scanning thickness less than 5.0 mm. For lymph node lesions, short diameter ≥15 mm.

⁃ Asymptomatic central nervous system metastases, or treated asymptomatic brain metastases, must be examined by computed tomography (CT) or magnetic resonance imaging (MRI) for no disease progression, stable for at least 3 months, and without steroid medication for at least 4 weeks;

⁃ No severe dysfunction of major organs; Laboratory tests meet the following criteria:

• WBC≥3.0×109 / L, ANC≥2.0×109 / L (no correction by granulocyte colony stimulating factor \[G-CSF\] or granulocyte macrophage colony stimulating factor \[GM-CSF\] within 14 days prior to screening), PLT≥100×109 /L (do not receive platelet infusion or thrombopoietin \[TPO\], thrombopoietin (TPO) receptor agonist or interleukin-11 \[IL-11\] within 14 days before screening), Hb≥90 g/L (do not receive blood transfusion or erythropoietin \[EPO\] correction within 14 days before screening);

∙ Blood BUN and blood creatinine within the range of 1.5 times the upper limit of normal value;

∙ TBIL≤ 1.5 times the upper limit of normal (total bilirubin \<2×ULN in subjects with Gilbert syndrome, or total bilirubin \<3×ULN in subjects with indirect bilirubin indicating extrahepatic cause of total bilirubin elevation);

∙ ALT and AST≤ 2.5 times the upper limit of normal value; Patients with liver metastases do not exceed 5 times the upper limit of normal;

∙ Normal coagulation function (PT, APPT within 1.5 times the upper limit of normal);

‣ Female subjects of childbearing age must have tested serum-negative for pregnancy before receiving the first trial drug;

‣ Female subjects of reproductive age and male subjects with partners of women of reproductive age received effective forms of contraception during and for 3 months after treatment;

‣ For subjects with genital herpes, need 3 months after the end of herpes;

‣ Voluntary signing of informed consent, expected compliance is good.

Locations
Other Locations
China
Peking University Cancer Hospital
RECRUITING
Beijing
Jilin Cancer Hospital
RECRUITING
Changchun
The first hospital of Jilin University
NOT_YET_RECRUITING
Changchun
Hunan Cancer Hospital
RECRUITING
Changsha
West China Hospital of Sichuan University
RECRUITING
Chengdu
Chongqing University Cancer Hospital
NOT_YET_RECRUITING
Chongqing
The First Affiliated Hospital of Dalian Medical University
NOT_YET_RECRUITING
Dalian
Fujian Cancer Hosptial
RECRUITING
Fuzhou
Dermatology Hospital of Southern Medical University
NOT_YET_RECRUITING
Guangzhou
Sun Yat-sen University Cancer Center
NOT_YET_RECRUITING
Guangzhou
Hainan Cancer Hospital
NOT_YET_RECRUITING
Haikou
Cancer Hospital Of The University Of Chinese Academy Of Sciences Zhejiang Cancer Hospital
RECRUITING
Hangzhou
Sir Run Run Shaw Hospital
NOT_YET_RECRUITING
Hangzhou
The First Affiliated Hospital of Harbin Medical University
NOT_YET_RECRUITING
Harbin
The Affiliated Cancer Hospital of Shandong First Medical University
NOT_YET_RECRUITING
Jinan
Yunnan Cancer Hospital
NOT_YET_RECRUITING
Kunming
The First Affiliated Hospital of Nanchang University
NOT_YET_RECRUITING
Nanchang
Nanjing Drum Tower Hospital
RECRUITING
Nanjing
Guangxi Medical University Cancer Hospital
NOT_YET_RECRUITING
Nanning
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Liaoning Cancer Hospital & Institute
NOT_YET_RECRUITING
Shenyang
The Fourth Hospital of Hebei Medical University and Hebei Tumor Hospital
NOT_YET_RECRUITING
Shijiazhuang
Shanxi Bethune Hospital
NOT_YET_RECRUITING
Taiyuan
Tianjin Medical University Cancer Institute & Hospital
NOT_YET_RECRUITING
Tianjin
The Affiliated Cancer Hospital, Xinjiang Medical University
NOT_YET_RECRUITING
Ürümqi
Weifang People's Hospital
RECRUITING
Weifang
Hubei Cancer Hospital
NOT_YET_RECRUITING
Wuhan
Union Hospital Tongji Medical College Huazhong University of Science and Technology
NOT_YET_RECRUITING
Wuhan
The First Affiliated Hospital of Xi'an Jiaotong University
NOT_YET_RECRUITING
Xi'an
The Third People's Hospital of Zhengzhou
RECRUITING
Zhengzhou
Contact Information
Primary
Wentao Xu
xuwentao@binhui-bio.com
15111009972
Time Frame
Start Date: 2023-03-08
Estimated Completion Date: 2027-03
Participants
Target number of participants: 340
Treatments
Experimental: OH2
OH2: 10\^7 CCID50/mL intratumoral injection, once every 2 weeks;
Active_comparator: Salvage chemotherapy or best supportive care
Salvage chemotherapy (single or combined, including but not limited to dacarbazine, temozolomide, taxoid, or platinum) or best supportive care selected by the investigator
Related Therapeutic Areas
Sponsors
Leads: Binhui Biopharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov

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