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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

ConditionsAdvanced Unresectable Gastric AdenocarcinomaEsophageal Squamous Cell CarcinomaAdvanced Gastroesophageal Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeOne Medicines

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tislelizumab

    Drug

    Administered by intravenous infusion

  • Capecitabine

    Drug

    Administered orally

  • 5-fluorouracil (5-FU)

    Drug

    Administered by intravenous infusion

  • Oxaliplatin

    Drug

    Administered by intravenous infusion

  • Leucovorin

    Drug

    Administered by intravenous infusion

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Gastric / Gastroesophageal Adenocarcinoma (GAC/GEA)Experimental treatment 5 interventions
Group B: Esophageal Squamous Cell Carcinoma (ESCC)Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

Number of participants Adverse events (AEs) and serious adverse events (SAEs) as characterized by type, frequency, severity (National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0 \[NCI-CTCAEv5.0\]\[1\]), timing, seriousness, and relationship to study treatment in GAC/GEA and ESCC participants, respectively

Time frame
Approximately 12 months

Secondary outcomes

1

Overall Response Rate (ORR) as Assessed by the Investigator

ORR is defined as the percentage of participants with partial or complete response, as assessed by the investigator using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Time frame
Approximately 12 months
2

Serum Concentrations of Tislelizumab

Time frame
Approximately 12 months
3

Percentage of Participants with Antidrug Antibodies (ADAs) to Tislelizumab

Time frame
Approximately 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

BeOne Medicines

Lead sponsor

Source ClinicalTrials.gov
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