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

Sponsor
BeiGene
Study ID
NCT05461794
Phase
PHASE2
Status
Terminated

Conditions

  • Esophageal Squamous Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sitravatinib — DRUG
    100 mg orally once daily
  • Tislelizumab — DRUG
    200 mg intravenously once every 3 weeks
  • Docetaxel — DRUG
    75 milligrams per square meter of body surface area (mg/m2) intravenously on Day 1 of every 21-day cycle
  • Irinotecan — DRUG
    125 mg/m2 intravenously on Days 1 and 8 of every 21-day cycle

Study Details

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.

Key Dates

Start date
Oct 3, 2022
Status verified
May 2025
Primary completion
Feb 26, 2024
Completion
Feb 26, 2024

Study Design

Enrollment
96 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Tislelizumab + Sitravatinib
    Sitravatinib administered orally and tislelizumab administered intravenously
  • Experimental: Arm B: Sitravatinib
    Sitravatinib administered orally
  • Experimental: Arm C: Investigator-chosen chemotherapy (ICC)
    Investigators chose between docetaxel or irinotecan

Primary Outcome Measure

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) ]

Related Studies