RecruitingPhase 2NCT06797297

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

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

Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Enrollment

180 participants

Start Date

Feb 24, 2025

Study Type

INTERVENTIONAL

Conditions

Melanoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares a new drug called IBI363 (a combination immune checkpoint blocker and interleukin-2 agent) to pembrolizumab (a standard immunotherapy) as a first-line treatment for people with a rare and harder-to-treat type of melanoma: mucosal melanoma (arising from mucous membranes) or acral melanoma (arising on palms, soles, or under nails). **You may be eligible if...** - You have been diagnosed with unresectable (cannot be removed by surgery) or metastatic mucosal or acral-type melanoma, stage III or IV - You have not previously received any systemic treatment for advanced melanoma - Your cancer has at least one measurable lesion on imaging - You are in good health and able to carry out daily activities **You may NOT be eligible if...** - You have already received systemic therapy for metastatic melanoma (with limited exceptions for adjuvant treatment) - You have active autoimmune disease, uncontrolled infections, or significant organ problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALIBI363

a mutated IL-2 cytokine fused to an anti-PD-1 antibody to combine IL-2 pathway stimulation with checkpoint blockade.

BIOLOGICALPembrolizumab

Pembrolizumab is a humanized monoclonal anti-PD1 antibody

Locations(31)

First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Beijing Jishuitan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Peking University Cancer Hospital & Institute, Beijing, China,

Beijing, Beijing Municipality, China

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Affiliated Tumor Hospital of Guangxi Medical University

Nanning, Guangxi, China

Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

The Third people's hospital of Zhengzhou

Zhengzhou, Henan, China

Henan Cancer Hospital

Zhengzhou, Hena, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Xiangya Second Hospital of Central South University

Changsha, Hunan, China

Hunan Cancer Hospital

Changsha, Hunan, China

Baotou Cancer Hospital

Baotou, Inner Mongolia, China

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, China

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

Jiangxi Provincial Cancer Hospital

Nanchang, Jiangxi, China

Jilin Cancer Hospital

Changchun, Jilin, China

The first hospital of Jilin University

Changchun, Jilin, China

Liaoning Cancer Hospital

Shenyang, Liaoning, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

Shandong First Medical University Affiliated Cancer Hospital

Jinan, Shandong, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

Second Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, China

The Affiliated Cancer Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Yunnan Cancer Hospital

Kunming, Yunnan, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT06797297

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