Spots Global Cancer Trial Database for A Phase 1b Study to Assess Sitravatinib in Combination With Tislelizumab in Patients With Advanced Solid Tumors.
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Trial Identification
Brief Title: A Phase 1b Study to Assess Sitravatinib in Combination With Tislelizumab in Patients With Advanced Solid Tumors.
Official Title: A Phase 1b Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of Sitravatinib in Combination With Tislelizumab in Patients With Advanced Solid Tumors
Study ID: NCT03666143
Conditions
Study Description
Brief Summary: This is an open-label, multicenter, non-randomized Phase 1b clinical trial for patients with histologically or cytologically confirmed locally advanced or metastatic tumors including non-squamous or squamous NSCLC, RCC, OC, or melanoma.
Detailed Description: All patients will receive sitravatinib 120 mg orally once daily in combination with tislelizumab 200 mg IV once every 3 weeks until occurrence of PD, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor. There will be 9 cohorts in the study. Approximately 20 patients will be enrolled into each cohort. The patients will be enrolled according to their tumor type and prior anti-programmed cell death protein-1 (PD-1)/PD-L1 antibody treatment. * Cohort A: Anti-PD-1/PD-L1 antibody refractory/resistant metastatic, non-squamous NSCLC * Cohort B: Anti-PD-1/PD-L1 antibody naïve metastatic, non-squamous NSCLC * Cohort C: Anti-PD-1/PD-L1 antibody refractory/resistant metastatic or advanced RCC * Cohort D (China-only): Metastatic or advanced RCC without prior systemic therapy * Cohort E: Anti-PD-1/PD-L1 antibody naïve recurrent and platinum resistant epithelial OC * Cohort F: Anti-PD-1/PD-L1 antibody treated metastatic, squamous NSCLC • Cohort G: Anti-PD-1/PD-L1 antibody refractory/resistant unresectable or metastatic melanoma * Cohort H: PD-L1 positive, aive, advanced or metastatic, non-squamous NSCLC * Cohort I: PD-L1 positive,naive, advanced or metastatic, squamous NSCLC
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Blacktown Cancer and Haematology Centre, Blacktown, New South Wales, Australia
ICON Cancer Foundation, South Brisbane, Queensland, Australia
Austin Hospital, Heidelberg, Victoria, Australia
Monash Health, Melbourne, Victoria, Australia
Nucleus Network, Melbourne, Victoria, Australia
Linear Clinical Research Limited, Perth, Western Australia, Australia
Beijing Cancer Hospital, Beijing, Beijing, China
Cancer Hospital Chinese Academy of Medical Science, Beijing, Beijing, China
Peking University First Hospital, Beijing, Beijing, China
Guangdong General Hospital, Guangzhou, Guangdong, China
Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, China
The First Hospital of Jilin University, Changchun, Jilin, China
Renji Hospital Shanghai Jiaotong University School of Medicine, Shanghai, Shanghai, China
Tianjin Medical University Cancer Institute & Hospital, Tianjin, Tianjin, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
Beijing Cancer Hospital, Beijing, , China
Contact Details
Name: Study Director
Affiliation: BeiGene
Role: STUDY_DIRECTOR
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