OncoMatch/Clinical Trials/NCT05868707
OH2 Injection in Melanoma
Is NCT05868707 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including OH2 and Salvage chemotherapy or best supportive care for melanoma.
Treatment: OH2 · Salvage chemotherapy or best supportive care — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Melanoma
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: chemotherapy — advanced
has failed at least second-line standard therapy (including chemotherapy, immunotherapy, and targeted therapy for those with genetic mutations)
Must have received: immunotherapy — advanced
has failed at least second-line standard therapy (including chemotherapy, immunotherapy, and targeted therapy for those with genetic mutations)
Must have received: targeted therapy — advanced
has failed at least second-line standard therapy (including chemotherapy, immunotherapy, and targeted therapy for those with genetic mutations)
Cannot have received: investigational agent
Use of investigational drug within 4 weeks prior to initial dosing
Cannot have received: antiviral therapy
Exception: except for hepatitis B patients on ongoing treatment who may be treated with Entecavir, Tenofovir dipifuroxide fumarate, or adefovir dipivoxil
Other investigational agents or antiviral therapies have been or are being used within 4 weeks prior to treatment, except for hepatitis B patients on ongoing treatment who may be treated with Entecavir, Tenofovir dipifuroxide fumarate, or adefovir dipivoxil
Lab requirements
Blood counts
WBC≥3.0×10^9/L, ANC≥2.0×10^9/L (no correction by G-CSF or GM-CSF within 14 days prior to screening), PLT≥100×10^9/L (no platelet infusion, TPO, TPO receptor agonist or IL-11 within 14 days before screening), Hb≥90 g/L (no blood transfusion or EPO correction within 14 days before screening)
Kidney function
Blood BUN and blood creatinine within the range of 1.5x ULN
Liver function
TBIL≤ 1.5x ULN (total bilirubin <2x ULN in subjects with Gilbert syndrome, or <3x ULN in subjects with indirect bilirubin indicating extrahepatic cause); ALT and AST≤ 2.5x ULN; Patients with liver metastases do not exceed 5x ULN
Cardiac function
Normal coagulation function (PT, APPT within 1.5x ULN)
No severe dysfunction of major organs; Laboratory tests meet the following criteria: ... (see above for details)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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