OH2 Injection in Melanoma
ConditionMelanoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorBinhui Biopharmaceutical Co., Ltd.
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
Severe medical conditions, including uncontrolled diabetes with medication, severe infections requiring systematic treatment, and active digestive tract ulcers;
Severe or uncontrolled heart disease requiring treatment, congestive heart failure rated III or IV by the New York Cardiology Association, unstable angina that cannot be controlled by medication, myocardial infarction in the last 6 months, ECG QTc interval: Severe arrhythmias requiring medication (other than atrial fibrillation or paroxysmal supraventricular tachycardia) ≥450 milliseconds in men and 470 milliseconds in women;
Patients with heart stents in place within 6 months;
Inadequately controlled hypertension, systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg;
Trial design
Design model
Parallel
Treatments tested in this trial
OH2
DrugOncolytic Type 2 Herpes Simplex Virus
Salvage chemotherapy or best supportive care
Drugsingle or combined, including but not limited to dacarbazine, temozolomide, taxoid, or platinum
Treatment groups
340 Participants
are divided into 2 treatment groupsGroup A: OH2Experimental treatment 1 intervention
Group B: Salvage chemotherapy or best supportive careActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Overall survival (OS)
Overall survival is defined as the interval from first dose to death from any cause.
Time frame
From date of randomization until the date of death from any cause，assessed up to 3 yearsSecondary outcomes
1
Objective response rate (ORR)
Determination of the ORR is calculated based on the proportion of patients achieving CR or PR using the RECIST v1.1 and iRECIST as assessed by investigators.
Time frame
Tumor assessments were performed every 8 weeks in first year and every 12 weeks thereafter until confirmed PD, start of new anticancer treatment, death, withdrawal of informed consent, loss of follow-up, or the end of the study, assessed up to 3 years2
Disease control rate (DCR)
DCR is defined as the percentage of participants with a best overall response of CR, PR, or SD.
Time frame
Tumor assessments were performed every 8 weeks in first year and every 12 weeks thereafter until confirmed PD, start of new anticancer treatment, death, withdrawal of informed consent, loss of follow-up, or the end of the study, assessed up to 3 years3
Progression-free survival (PFS)
Progression-free survival is defined as the time from first dose to the earlier event of confirmed PD or death from any cause.
Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years4
Durable Response Rate (DRR)
DRR is defined as the percentage of participants with a best overall response of CR or PR using the RECIST/iRECIST assessment with a duration of response of at least 6 months.
Time frame
Tumor assessments were performed every 8 weeks in first year and every 12 weeks thereafter until confirmed PD, start of new anticancer treatment, death, withdrawal of informed consent, loss of follow-up, or the end of the study，assessed up to 3 yearsSponsors and contacts
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Source ClinicalTrials.gov