A Study to Evaluate the Efficacy and Safety of IBI363 Monotherapy Compared to Pembrolizumab in Pa… (NCT06797297) | Clinical Trial Compass
RecruitingPhase 2
A Study to Evaluate the Efficacy and Safety of IBI363 Monotherapy Compared to Pembrolizumab in Patients With Unresectable Locally Advanced or Metastatic Mucosal or Acral Melanoma Who Had Not Previously Received Systemic Therapy
China180 participantsStarted 2025-02-24
Plain-language summary
This is a Phase II, open-label, randomized, multi-center study to assess the efficacy and safety of IBI363 monotherapy compared to Pembrolizumab in the treatment of patients with unresectable locally advanced or metastatic mucosal or acral melanoma who had not previously received systemic therapy.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Histologically or cytologically confirmed unresectable, locally advanced or metastatic mucosal or acral-type melanoma, according to the American Joint Committee on Cancer (AJCC) 8th edition stage III-IV.
✓. No prior systemic treatment for unresectable or metastatic melanoma; Prior adjuvant or neoadjuvant therapy (except for disease progression to unresectable or metastatic melanoma during adjuvant or neoadjuvant therapy or within 6 months after treatment discontinuation) was permitted.
✓. Have at least one measurable lesion (target lesion) according to RECIST v1.1. For lesions that have previously received radiotherapy or intratumoral injection, measurable lesions that progress to the criteria specified in RECIST1.1 after treatment may be considered.
✓. The Eastern Cooperative Oncology Group Physical Status Score (ECOG PS) is 0 or 1.
✓. Expected survival time no less than 3 months.
✓. Female subjects of childbearing age or male subjects whose partner is a female of childbearing age agree to strictly use effective contraception throughout the treatment period and for 6 months after the treatment period.
✓. Breastfeeding women must agree to strictly refrain from breastfeeding during the entire treatment period and for 6 months after the treatment period.
Exclusion criteria
✕. Women who are pregnant or plan to become pregnant within 6 months before, during, or after the last dose of the study drug.
✕. Active or symptomatic central nervous system metastases
. Any of the following hematological abnormalities were present at baseline \* (within 7 days before the first administration of the study drug) :
✕. Any of the following serum biochemical abnormalities are present at baseline (within 7 days before the first dose) :
✕. Any of the following coagulation parameters are abnormal at baseline (within 7 days before the first dose) :
✕. There is a history of active thrombosis or deep vein thrombosis or pulmonary embolism in the 4 weeks prior to initial administration of the investigatory drug, unless the disease is adequately treated and is considered stable by the investigator.
✕. Uncontrolled bleeding or a known tendency to bleed.
✕. Cardiovascular and cerebrovascular diseases of significant clinical significance.