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

BeiGene

Status and phase: Terminated; Phase 2

Conditions: Esophageal Squamous Cell Carcinoma

Treatments: Drug: Irinotecan; Drug: Tislelizumab; Drug: Sitravatinib; Drug: Docetaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT05461794

CTR20222088 (Other Identifier)

BGB-A317-Sitravatinib-203

Details and patient eligibility

About

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.

Enrollment: 96 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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 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
3. Eastern Cooperative Oncology Group (ECOG) 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. 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)
3. 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
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, 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 3 patient groups

Arm A: Tislelizumab + Sitravatinib

Experimental group

Description:

Sitravatinib administered orally and tislelizumab administered intravenously

Treatment:

Drug: Sitravatinib

Drug: Tislelizumab

Arm B: Sitravatinib

Experimental group

Description:

Sitravatinib administered orally

Treatment:

Drug: Sitravatinib

Arm C: Investigator-chosen chemotherapy (ICC)

Experimental group

Description:

Investigators chose between docetaxel or irinotecan

Treatment:

Drug: Docetaxel

Drug: Irinotecan