OncoMatch/Clinical Trials/NCT05868707
OH2 Injection in Melanoma
Is NCT05868707 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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.
Frequently asked questions
Is NCT05868707 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior investigational agent, antiviral therapy disqualifies patients from enrollment.
What disease stage is eligible?
Stage III or IV is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages