Clinical Trials/NCT05461794

NCT05461794

Terminated

Phase 2

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

BeiGene31 sites in 1 country96 target enrollmentOctober 3, 2022

ConditionsEsophageal Squamous Cell Carcinoma

InterventionsSitravatinib Tislelizumab Docetaxel Irinotecan

DrugsSitravatinib Tislelizumab Docetaxel Irinotecan

Overview

Phase: Phase 2
Intervention: Sitravatinib
Conditions: Esophageal Squamous Cell Carcinoma
Sponsor: BeiGene
Enrollment: 96
Locations: 31
Primary Endpoint: Arms A and C: Overall Response Rate (ORR)
Status: Terminated
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The study aimed to evaluate the efficacy and safety of sitravatinib in combination with tislelizumab as a second- or third-line treatment for participants with locally advanced, unresectable, or metastatic esophageal squamous cell carcinoma (ESCC) who experienced disease progression following prior systemic chemotherapy.

Registry

clinicaltrials.gov

Start Date

October 3, 2022

End Date

February 26, 2024

Last Updated

10 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

BeiGene

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologically or cytologically confirmed locally advanced unresectable or metastatic ESCC, not amenable to treatment with curative intent
•At least 1 measurable lesion as defined per Response Evaluation Criteria in Solid Tumors (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
•Eastern Cooperative Oncology Group (ECOG) score ≤ 1
•Adequate organ function as indicated by the following laboratory values as indicated by the laboratory tests performed ≤ 7 days before randomization

Exclusion Criteria

•Have any contraindication for receiving treatment with both docetaxel and irinotecan
•Participants 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)
•Participants 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
•History of gastrointestinal perforation and/or fistula or aorto-esophageal fistula within 6 months before randomization
•Have received prior anticancer agents that have same mechanism of action as sitravatinib (eg, receptor tyrosine kinases (RTKs) with a similar target profile or Vascular Endothelial Growth Factor (VEGF)/Vascular Endothelial Growth Factor Receptor-targeted (VEGFR) monoclonal antibodies)
•Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Arms & Interventions

Arm A: Tislelizumab + Sitravatinib

Sitravatinib administered orally and tislelizumab administered intravenously

Intervention: Sitravatinib

Arm A: Tislelizumab + Sitravatinib

Sitravatinib administered orally and tislelizumab administered intravenously

Intervention: Tislelizumab

Arm B: Sitravatinib

Sitravatinib administered orally

Intervention: Sitravatinib

Arm C: Investigator-chosen chemotherapy (ICC)

Investigators chose between docetaxel or irinotecan

Intervention: Docetaxel

Arm C: Investigator-chosen chemotherapy (ICC)

Investigators chose between docetaxel or irinotecan

Intervention: Irinotecan

Outcomes

Primary Outcomes

Arms A and C: Overall Response Rate (ORR)

Time Frame: Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months)

ORR is defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) as assessed by the investigator per the Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1.

Secondary Outcomes

Duration of Response (DOR)(Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months))
Overall Survival (OS)(Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months))
Clinical Benefit Rate (CBR)(Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months))
Progression Free Survival (PFS)(Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months))
Number of Participants With Adverse Events(From the first dose to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).)
Disease Control Rate (DCR)(Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months))
Arms A and B: Overall Response Rate (ORR)(Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months))