Phase
Condition
Cancer/tumors
Kidney Cancer
Melanoma
Treatment
Tislelizumab
BGB-A445
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Participants who were histologically or cytologically confirmed advanced and/ormetastatic cancer. UC participants (Cohort A and B), RCC patients (Cohort C and D)or melanoma participants (Cohort E and F) who have received at least 1 but no morethan 3 lines of prior systemic therapy. Cisplatin ineligible UC participants (CohortG) who have received no prior systemic therapy and have PD-L1 CPS ≥ 10. Melanomapatients (Cohort H) with non-mucosal melanoma who have no previous systemictreatment. Melanoma participants (Cohort I) with non-mucosal melanoma who were CPIpretreated and have 1 or 2 lines of prior systemic therapy. Participants must nothave received prior therapy targeting OX40 or any other T-cell agonists.
Has at least 1 measurable lesion as defined per RECIST v1.1.
Participants must be able to provide an archived formalin-fixed paraffin embedded (FFPE) tumor tissue sample
ECOG PS ≤ 1 (Participants with UC could have an ECOG PS ≤ 2) and a life expectancyof≥ 3 months
Adequate organ function as indicated by the laboratory values up to the first doseof study drug(s)
Exclusion
Key Exclusion Criteria:
Active leptomeningeal disease or uncontrolled brain metastasis
Active autoimmune diseases or history of autoimmune diseases that may relapse orhistory of life-threatening toxicity related to prior immune therapy
Any active malignancy ≤ 2 years before the first dose of study drug(s) except forthe specific cancer under investigation in this study and any locally recurringcancer that has been treated with curative intent
Any condition that required systemic treatment with either corticosteroids (> 10 mgdaily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 daysbefore the first dose of study drug(s), with the following exceptions:
Adrenal replacement steroid (dose ≤ 10 mg daily of prednisone or equivalent)
Topical, ocular, intra-articular, intranasal, or inhalational corticosteroidwith minimal systemic absorption
Short course (≤ 7 days) of corticosteroid prescribed prophylactically (eg, forcontrast dye allergy) or for the treatment of a nonautoimmune condition (eg,delayed-type hypersensitivity reaction caused by contact allergen)
With uncontrolled diabetes, or > Grade 1 laboratory test abnormalities in potassium,sodium, or corrected calcium despite standard medical management, or ≥ Grade 3hypoalbuminemia occurring ≤ 14 days before the first dose of study drug(s)
Note: Other protocol defined Inclusion/Exclusion criteria may apply
Study Design
Connect with a study center
Peking University First Hospital
Beijing, Beijing 100034
ChinaSite Not Available
Beijing Cancer Hospital
Beijing, Beijing Municipality 100142
ChinaSite Not Available
Beijing Cancer Hospital
Beijing 1816670, Beijing Municipality 2038349 100142
ChinaSite Not Available
Fujian Cancer Hospital
Fuzhou, Fujian 350014
ChinaSite Not Available
Fujian Cancer Hospital
Fuzhou 1810821, Fujian 1811017 350014
ChinaSite Not Available
Lanzhou University Second Hospital
Lanzhou, Gansu 730030
ChinaActive - Recruiting
The Second Hospital and Clinical Medical School, Lanzhou University
Lanzhou, Gansu 730030
ChinaSite Not Available
The Second Hospital and Clinical Medical School, Lanzhou University
Lanzhou 1804430, Gansu 1810676 730030
ChinaSite Not Available
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong 510060
ChinaSite Not Available
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong 510000
ChinaSite Not Available
Sun Yat Sen University Cancer Center
Guangzhou 1809858, Guangdong 1809935 510060
ChinaSite Not Available
Zhujiang Hospital of Southern Medical University
Guangzhou 1809858, Guangdong 1809935 510000
ChinaSite Not Available
Guangxi Medical University Cancer Hospital
Nanning, Guangxi 530021
ChinaSite Not Available
The Tumor Hospital Affiliated to Guangxi Medical University
Nanning, Guangxi 530021
ChinaSite Not Available
The Tumor Hospital Affiliated to Guangxi Medical University
Nanning 1799869, Guangxi 1809867 530021
ChinaSite Not Available
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang 150000
ChinaSite Not Available
Henan Cancer Hospital
Zhengzhou, Henan 450000
ChinaSite Not Available
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan 450052
ChinaSite Not Available
The Third Peoples Hospital of Zhengzhou
Zhengzhou, Henan 450099
ChinaCompleted
The First Affiliated Hospital of Zhengzhou University
Zhengzhou 1784658, Henan 1808520 450052
ChinaSite Not Available
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei 430030
ChinaSite Not Available
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan 1791247, Hubei 1806949 430030
ChinaSite Not Available
The Second Xiangya Hospital of Central South University
Changsha, Hunan 410011
ChinaSite Not Available
The Second Xiangya Hospital of Central South University
Changsha 1815577, Hunan 1806691 410011
ChinaSite Not Available
Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu 210008
ChinaSite Not Available
Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
Nanjing 1799962, Jiangsu 1806260 210008
ChinaSite Not Available
The First Hospital of Jilin University
Changchun, Jilin 130021
ChinaSite Not Available
The First Hospital of Jilin University
Changchun 2038180, Jilin 2036500 130021
ChinaSite Not Available
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning 110042
ChinaSite Not Available
Liaoning Cancer Hospital and Institute
Shenyang 2034937, Liaoning 2036115 110042
ChinaSite Not Available
Shandong Cancer Hospital
Jinan, Shandong 250117
ChinaSite Not Available
Jining No Peoples Hospital Main Branch
Jining, Shandong 272002
ChinaActive - Recruiting
Jining No Peoples Hospital West Branch
Jining, Shandong 272000
ChinaSite Not Available
Jining No1 Peoples Hospital West Branch
Jining, Shandong 272000
ChinaSite Not Available
Shandong Cancer Hospital
Jinan 1805753, Shandong 1796328 250117
ChinaSite Not Available
Jining No Peoples Hospital West Branch
Jining 1805518, Shandong 1796328 272000
ChinaSite Not Available
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi 030013
ChinaSite Not Available
Shanxi Provincial Cancer Hospital
Taiyuan 1793511, Shanxi 1795912 030013
ChinaSite Not Available
West China Hospital, Sichuan University
Chengdu, Sichuan 610041
ChinaSite Not Available
West China Hospital, Sichuan University
Chengdu 1815286, Sichuan 1794299 610041
ChinaSite Not Available
The Second Affiliated Hospital of Tianjin Medical University
Tianjin, Tianjin 300000
ChinaSite Not Available
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality 300060
ChinaSite Not Available
Tianjin Medical University Cancer Institute and Hospital
Tianjin 1792947, Tianjin Municipality 1792943 300060
ChinaSite Not Available
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang 325000
ChinaSite Not Available
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou 1791388, Zhejiang 1784764 325000
ChinaSite Not Available

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