A Study to Investigate Tislelizumab (BGB-A317) Versus Placebo in Combination With Concurrent Chemoradiotherapy in Participants With Localized Esophageal Squamous Cell Carcinoma

BeiGene

Status and phase: Completed; Phase 3

Conditions: Esophageal Squamous Cell Carcinoma (ESCC)

Treatments: Drug: Placebo; Drug: Tislelizumab; Drug: Cisplatin; Radiation: Radiotherapy; Drug: Paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT03957590

CTR20190198 (Registry Identifier)

BGB-A317-311

Details and patient eligibility

About

This is a phase 3, randomized, double-blind, placebo-controlled study to compare the efficacy and safety of BGB-A317 versus placebo with chemoradiotherapy in participants with Localized Esophageal Squamous Cell Carcinoma.

Enrollment: 370 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• 18 to 75 years on the day of signing the informed consent form
• Histologically confirmed diagnosis of localized ESCC
• Measurable and/or non-measurable disease defined per RECIST v1.1
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
• Adequate organ function

Key Exclusion Criteria:

• Indicators of severe malnutrition
• Clinically uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention within 2 weeks prior to randomization
• Known to be intolerable or resistant to treatment with the protocol-specified chemotherapy
• Received prior radiotherapy or therapies targeting PD-1, PD-L1, PD-L2 or other immune-oncology therapies
• Active autoimmune diseases or history of autoimmune diseases that may relapse

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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370 participants in 2 patient groups, including a placebo group

Tislelizumab + chemoradiotherapy

Experimental group

Description:

Tislelizumab once every 3-week cycle (Q3W) + paclitaxel on Day 1 of every cycle, for a total of 2 cycles + cisplatin on Day 1 to 3 of every cycle (3 weeks), for a total of 2 cycles + Radiotherapy

Treatment:

Radiation: Radiotherapy

Drug: Paclitaxel

Drug: Cisplatin

Drug: Tislelizumab

Placebo combined + chemoradiotherapy

Placebo Comparator group

Description:

Placebo once every 3-week cycle (Q3W) + paclitaxel on Day 1 of every cycle, for a total of 2 cycles + cisplatin on Day 1 to 3 of every cycle (3 weeks), for a total of 2 cycles + Radiotherapy

Treatment:

Radiation: Radiotherapy

Drug: Paclitaxel

Drug: Cisplatin

Drug: Placebo