Multicenter, Randomized, Double-Blind, 2-Treatment Arm Study to Assess Comparative Pharmacokinetics, Efficacy, Safety and Immunogenicity Between Intravenous AVT32-DRL_PB and Keytruda® as an Adjuvant Treatment in Participants with Stage IIB/C-III Melanoma Following Complete Resection

Alvotech Swiss AG0 个研究点目标入组 24 人开始时间: 2026年9月30日最近更新: 2026年8月3日

适应症

试验速览

暂无简介。

•? Participants (male/female) =18 years of age at the time of signing the ICF
•? Participants with Stage IIB, IIC, or III histologically confirmed cutaneous melanoma (as classified by the American Joint Committee on Cancer’s Cancer Staging Manual, 8th Edition) who have undergone complete resection with negative surgical margins. No evidence of past or current satellites or in-transit metastases.
•? Disease status for the post-surgery baseline assessment must be documented by full chest/abdomen/pelvis computed tomography (CT) or magnetic resonance imaging (MRI) with neck CT and/or MRI (for head and neck
•primaries) and by a complete clinical examination after the informed consent form (ICF) has been signed and before enrollment.
•? Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at the time of enrollment.

•? Prior active malignancy within the previous 3 years except for locally curable cancers that undergone potentially curative therapy, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of
•the prostate, cervix, or breast.
•? Participants with a history of mucosal or uveal melanoma, even if diagnosis and treatment were completed >5 years ago.
•? Have had a solid organ transplant or bone marrow (stem cell) transplant that used donor stem cells (allogenic).
•? Has received prior therapy with an anti-programmed cell death receptor 1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti-programmed cell death ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137)
•? Has received prior systemic anticancer therapy for melanoma including investigational agents.

发起方