OncoMatch/Clinical Trials/NCT04616443
OH2 Injection in Combination With HX008 for Melanoma.
Is NCT04616443 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments including OH2 and HX008 for melanoma.
Treatment: OH2 · HX008 — This phase Ib study evaluates the safety and efficacy of OH2 in combination with HX008, an anti-PD-1 antibody, in patients with Melanoma. OH2 is an oncolytic virus developed upon genetic modifications of the herpes simplex virus type 2 strain HG52, allowing the virus to selectively replicate in tumors. Meanwhile, the delivery of the gene encoding human granulocyte macrophage colony-stimulating factor (GM-CSF) may induce a more potent antitumor immune response.
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)
Demographics
Prior therapy
Must have received: conventional treatment
Patients who have failed in conventional treatment (including PD-1 monotherapy) (disease progression or intolerance) or who have failed in previously assisted PD-1 monotherapy (last assisted PD-1 treatment relapse or metastasis within 6 months)
Cannot have received: other experimental therapies or antiviral therapy
Other experimental therapies or antiviral therapy are used or are being used within 4 weeks of treatment
Lab requirements
Blood counts
WBC≥3.0×10^9/L, ANC≥2.0×10^9/L, PLT≥100×10^9/L, Hb≥90 g/L
Kidney function
BUN and Scr. were in the upper limit of 1.5 times of the normal value
Liver function
TBIL≤ 1.5 times the upper limit of the normal value; ALT and AST ≤ 2.5 times the upper limit of normal value; The value of patients with liver metastasis did not exceed 5 times the upper limit of normal value.
(a) WBC≥3.0×10^9／L，ANC≥2.0×10^9／L ，PLT≥100×10^9／L，Hb≥90 g/L； (b) BUN and Scr. were in the upper limit of 1.5 times of the normal value; (c) TBIL≤ 1.5 times the upper limit of the normal value. (d) ALT and AST ≤ 2.5 times the upper limit of normal value; The value of patients with liver metastasis did not exceed 5 times the upper limit of normal value. (e) Coagulation function is normal (PT and APPT are within 1.5 times of the upper limit of normal value).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT04616443 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior other experimental therapies or antiviral therapy disqualifies patients from enrollment.
What disease stage is eligible?
Stage III or IV is required.
Is there an age limit?
Yes. Patients must be 75 years or younger.
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