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
Qualifiers
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
Treatments tested in this trial
- OH2
- Salvage chemotherapy or best supportive care
Treatment groups
340 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov