A Study to Evaluate Efficacy and Safety of Tislelizumab Plus Chemotherapy for Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Adenocarcinoma and Esophageal Squamous Cell Carcinoma in Racial and Ethnic Minority Patients in the United States

BeOne Medicines

Status and phase

Enrolling

Phase 2

Conditions

Advanced Unresectable Gastric Adenocarcinoma

Esophageal Squamous Cell Carcinoma

Advanced Gastroesophageal Adenocarcinoma

Treatments

Drug: Leucovorin

Drug: 5-fluorouracil (5-FU)

Drug: Capecitabine

Drug: Oxaliplatin

Drug: Tislelizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT07554521

BGB-A317-217

Details and patient eligibility

About

The purpose of this study is to characterize the clinical effects of tislelizumab, including pharmacokinetics (PK), activity, and safety assessments in US racial and ethnic minority patients with human epidermal growth factor receptor 2 (HER2)-negative, programmed death-ligand 1(PD-L1)-positive, unresectable or metastatic gastric or gastroesophageal cancer (GAC/GEA) or esophageal squamous cell carcinoma (ESCC). The study duration will be up to approximately 6 years.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Self-identifies as a member of racial and/or ethnic minority populations as defined by the Food and Drug Administration (FDA), such as Black or African American, Hispanic or Latino, American Indian or Alaska Native, and Native Hawaiian or Other Pacific Islander
Histologically confirmed, locally advanced unresectable or metastatic gastric or gastroesophageal adenocarcinoma (GAC/GEA) or esophageal squamous cell carcinoma (ESCC)
No previous systemic therapy for locally advanced unresectable or metastatic GAC/GEA or ESCC
At least 1 measurable lesion per RECIST v1.1 as determined by investigator assessment
Patients must have positive tumor programmed death-ligand 1 (PD-L1) expression. Documented PD-L1 results are acceptable
Eastern Cooperative Oncology Group (ECOG) Performance Status score ≤ 1
Adequate organ function as indicated by the following laboratory values ≤ 14 days prior to study treatment
Women of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and ≥ 120 days after the last dose of tislelizumab and ≥ 180 days after the last dose of chemotherapy, and have a negative urine or serum pregnancy test ≤ 7 days prior to study treatment
Non-sterile males must be willing to use a highly effective method of birth control for the duration of the study and for ≥ 120 days after the last dose of tislelizumab and ≥ 180 days after the last dose of chemotherapy

Exclusion criteria

Patient has squamous cell or undifferentiated or other histological type gastric cancer
Active leptomeningeal disease or uncontrolled brain metastasis. Patients with equivocal findings or with confirmed brain metastases are eligible for enrollment provided that they are asymptomatic and radiologically stable without the need for corticosteroid treatment for ≥ 4 weeks before study treatment.
Patients with evidence of esophageal/bronchial or esophageal/aorta fistula, or complete esophageal obstruction not amenable to treatment.
Diagnosed with GAC/GEA with positive human epidermal growth factor receptor 2 (HER2). Results of the tumor HER2 testing must be known prior to study treatment
Active autoimmune diseases or history of autoimmune diseases that may relapse Note: Patients with the following diseases are not excluded and may proceed to further screening:
1. Controlled Type I diabetes
2. Hypothyroidism (provided it is managed with hormone replacement therapy only)
3. Controlled celiac disease
4. Skin diseases not requiring systemic treatment (eg, vitiligo, psoriasis, alopecia)
5. Any other disease that is not expected to recur in the absence of external triggering factors
Any active malignancy ≤ 2 years before study treatment, with the exception of the specific cancer under investigation in this trial or any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast)
Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (at least once a week) and/or diuretics within 7 days prior to study treatment (the cytological confirmation of any effusion is permitted)
Have clinically significant bleeding (Common Terminology Criteria for Adverse Events (CTCAE) ≥ Grade 2) from the GI tract within 1 month prior to study treatment
Have a history of gastrointestinal (GI) perforation (CTCAE ≥ Grade 2) and/or fistulae (including prior gastric fistula operation) within 6 months prior to study treatment
Have a clinically significant bowel obstruction (CTCAE ≥ Grade 2)
Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before study treatment.

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

Gastric / Gastroesophageal Adenocarcinoma (GAC/GEA)

Experimental group

Description:

Participants will receive tislelizumab (either 200 mg every 3 weeks or 150 mg every 2 weeks, matching the chemotherapy regimen) and one of the following chemotherapy regimens: * FOLFOX: oxaliplatin 85 mg + leucovorin on Day 1, followed by 5-fluorouracil (5-FU) (2400 to 2800 mg) IV, repeated every 2 weeks (Q2W). * CAPOX: oxaliplatin 130 mg Day 1 + capecitabine 1000 mg orally twice daily for consecutive 14 days, repeated every 3 weeks (Q3W). * Cisplatin 80 mg Day 1 + 5-FU 800 mg IV continuous infusion over 24 hours daily on Day 1 to Day 5, repeated Q3W.

Treatment:

Drug: Tislelizumab

Drug: Oxaliplatin

Drug: Capecitabine

Drug: 5-fluorouracil (5-FU)

Drug: Leucovorin

Esophageal Squamous Cell Carcinoma (ESCC)

Experimental group

Description:

Participants will receive tislelizumab 150 mg Q2W and FOLFOX chemotherapy.

Treatment:

Drug: Tislelizumab