Study To Investigate the Efficacy and Safety of Sitravatinib in Combination With Tislelizumab in Participants With Esophageal Squamous Cell Carcinoma

A Phase 2, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sitravatinib in Combination With Tislelizumab in Patients With Locally Advanced Unresectable or Metastatic Esophageal Squamous Cell Carcinoma That Progressed on or After Anti-PD-(L)1 Antibody Therapy

The purpose of this study is to investigate the efficacy and safety of sitravatinib in combination with tislelizumab for the treatment of participants with esophageal squamous cell carcinoma

Study Overview

• Status: Terminated
• Conditions: Esophageal Squamous Cell Carcinoma
• Intervention / Treatment: Drug: Sitravatinib; Drug: Tislelizumab; Drug: Docetaxel; Drug: Irinotecan

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: BeiGene; Phone Number: 1-877-828-5568; Email: clinicaltrials@beigene.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230088
      • Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital
    • Hefei, Anhui, China, 230036
      • Anhui Provincial Hospital South Brance
  • Beijing
    • Beijing, Beijing, China, 100142
      • Beijing Cancer Hospital
    • Beijing, Beijing, China, 100050
      • Beijing Friendship Hospital, Capital Medical University
    • Beijing, Beijing, China, 101149
      • Beijing Luhe Hospital, Capital Medical University
  • Fujian
    • Fuzhou, Fujian, China, 350014
      • Fujian cancer hospital
    • Fuzhou, Fujian, China, 350005
      • The First Affiliated Hospital Of Fujian Medical University
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat Sen University Cancer Center
    • Guangzhou, Guangdong, China, 510700
      • Sun Yat Sen University Cancer Center(Huangpu Campus)
    • Shantou, Guangdong, China, 515031
      • Cancer Hospital of Shantou University Medical College
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • The Tumor Hospital Affiliated to Guangxi Medical University
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150000
      • Harbin Medical University Cancer Hospital
  • Henan
    • Xinxiang, Henan, China, 453100
      • The First Affiliated Hospital of Xinxiang Medical University
    • Zhengzhou, Henan, China, 450000
      • Henan Cancer Hospital
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
    • Xiangyang, Hubei, China, 441021
      • Xiangyang Central Hospital
  • Jiangsu
    • Yangzhou, Jiangsu, China, 225001
      • Northern Jiangsu Peoples Hospital
  • Jiangxi
    • Ganzhou, Jiangxi, China, 341000
      • Ganzhou Peoples Hospital Ganzhou Hospital Affiliated to Nanchang University
  • Jilin
    • Changchun, Jilin, China, 130021
      • Jilin Cancer Hospital
  • Liaoning
    • Shenyang, Liaoning, China, 110042
      • Liaoning Cancer Hospital and Institute
  • Shandong
    • Jinan, Shandong, China, 250117
      • Shandong Cancer Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
    • Shanghai, Shanghai, China, 200032
      • Affiliated Zhongshan Hospital of Fudan University
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital, Sichuan University
    • Chengdu, Sichuan, China, 610071
      • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
  • Tianjin
    • Tianjin, Tianjin, China, 300052
      • Tianjin Medical University General Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Zhejiang Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

1. Histologically or cytologically confirmed locally advanced unresectable or metastatic ESCC, not amenable to treatment with curative intent
2. At least 1 measurable lesion as defined per RECIST v1.1 as determined by local site investigator/radiology assessment ≤ 28 days before randomization Note: Lesions that had been previously irradiated were considered evaluable provided
3. ECOG PS score ≤ 1
4. Adequate organ function as indicated by the following laboratory values as indicated by the laboratory tests performed ≤ 7 days before randomization

Key Exclusion Criteria:

1. Have any contraindication for receiving treatment with both docetaxel and irinotecan
2. Patients with tumor located around important vascular structures as shown by imaging or the investigator determines that the tumor is likely to invade important blood vessels and may cause fatal bleeding (ie, radiologic evidence of tumors invading or abutting major blood vessels)
3. Patients with tumor that invades into organs located adjacent to the esophageal disease site (eg, aorta or respiratory tract) that has an increased risk of fistula during the study treatment period as assessed by the investigator
4. . History of gastrointestinal perforation and/or fistula or aorto-esophageal fistula within 6 months before randomization
5. Have received prior anticancer agents that have same mechanism of action as sitravatinib (eg, RTK inhibitor with a similar target profile or VEGF- or VEGFR-targeted monoclonal antibodies) ther protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A: Sitravatinib + Tislelizumab; Sitravatinib administered orally and tislelizumab administered intravenously	Drug: Sitravatinib; administered orally; Drug: Tislelizumab; administered intravenously
Experimental: Arm B: Sitravatinib; Sitravatinib administered orally	Drug: Sitravatinib; administered orally
Experimental: Arm C: Investigator-chosen Chemotherapy; Docetaxel or Irinotecan	Drug: Docetaxel; administered intravenously; Drug: Irinotecan; administered intravenously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arms A and C: Overall Response Rate (ORR)	ORR is defined as the proportion of participants with a confirmed complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1	Up to 2 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Response (DOR)	defined as the time from the first confirmed objective response until the first documentation of disease progression or death, whichever comes first	Up to 2 Years
Arms A and C: Overall Survival (OS)	OS is defined as the time from the date of randomization to the date of death due to any cause	Up to 2 Years
Disease Control Rate (DCR)	DCR is defined as the percentage of participants whose best overall response is complete response, partial response, or stable disease, as assessed by the investigator per the Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1	Up to 2 Years
Clinical Benefit Rate (CBR)	CBR is defined as the percentage of participants who have complete response, partial response, and stable disease, as assessed by the investigator per the Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1	Up to 2 Years
Progression Free Survival (PFS)	PFS is defined as the time from the date of randomization until first documentation of progression or death, whichever comes first, as assessed by the investigator Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1	Up to 2 Years
Overall Response Rate (ORR) as assessed by the investigator	defined as the proportion of patients with a confirmed complete response or partial response per RECIST v1.1	Up to 2 Years
Number of participants with adverse events (AEs)	Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)	Up to 2 Years
Number of participants with clinically significant changes from baseline in clinical laboratory values	Laboratory values include hematology, clinical chemistry, coagulation, and urinalysis	Up to 2 Years
Number of participants with clinically significant changes from baseline in vital signs	Vital signs include blood pressure and pulse rate	Up to 2 Years

Collaborators and Investigators

• Sponsor: BeiGene

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2022
• Primary Completion (Actual): February 26, 2024
• Study Completion (Actual): February 26, 2024

Study Registration Dates

• First Submitted: July 14, 2022
• First Submitted That Met QC Criteria: July 14, 2022
• First Posted (Actual): July 18, 2022

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: esophageal squamous cell carcinoma
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Neoplasms, Squamous Cell; Esophageal Neoplasms; Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Topoisomerase Inhibitors; Antineoplastic Agents, Immunological; Topoisomerase I Inhibitors; Docetaxel; Irinotecan; Tislelizumab
• Other Study ID Numbers: BGB-A317-Sitravatinib-203; CTR20222088 (Other Identifier: ChinaDrugTrials)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No