OH2 Injection in Melanoma
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.
| Condition(s) | Melanoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: 1. Over 18 years old, male or female; 2. 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; 3. The overall percentage of subjects with mucosal melanoma will not exceed 22%; 4. Eastern Oncology Consortium (ECOG) physical condition score ECOG 0 \~ 1; 5. The expected survival time is more than 3 months; 6. At least 4 weeks after c |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Binhui Biopharmaceutical Co., Ltd. |
| Locations | Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Fuzhou, Fujian, China; Guangzhou, Guangdong, China; Guangzhou, Guangdong, China; Nanning, Guangxi, China (+24 more sites) |
| Start date | 2023-03-08 |
| NCT ID | NCT05868707 |
| Official listing | https://clinicaltrials.gov/study/NCT05868707 |