A Phase II, Open-label, Randomized, Multi-center Study to Evaluate the Efficacy and Safety of IBI363 Monotherapy Compared to Pembrolizumab in Patients With Unresectable Locally Advanced or Metastatic Mucosal and Acral Melanoma Who Had Not Previously Received Systemic Therapy
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.
• 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 target lesions of this study must be measured by imaging (enhanced CT or MRI. Plain scan CT or MRI can be accepted after communication with the sponsor if the subjects are allergic to contrast media or have other conditions that are not suitable for enhanced CT or MRI).
• Skin lesions or other superficial sites that cannot be repeatedly measured by imaging can only be used as non-target lesions.
• 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.