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Compares treatment options for Metastatic Gastric Adenocarcinoma
Official title A Study to Investigate Tislelizumab Administered as Subcutaneous Injection Versus Intravenous Infusion Plus Chemotherapy in Patients With Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
ClinicalTrials.gov ID: NCT07043400
What this study is testing
What is Subcutaneous Tislelizumab?
Subcutaneous Tislelizumab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for metastatic gastric adenocarcinoma.
Also referred to as BGB-A317.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is designed to assess the levels of drug exposure following treatment with tislelizumab administered as a subcutaneous (SC) injection compared to intravenous infusion (IV) as first-line therapy in adults with gastric or gastroesophageal junction (GEJ) that is locally advanced and cannot be surgically removed or has spread from the stomach to other areas of the body. Approximately 351 patients will be participating in this study.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically confirmed, locally advanced unresectable or metastatic gastric/ gastroesophageal junction (GEJ) adenocarcinoma.
- No previous systemic therapy for locally advanced unresectable or metastatic gastric/GEJ cancer.
- At least 1 measurable or nonmeasurable lesion per RECIST v1.1 as determined by investigator assessment.
- Must be able to provide tumor tissues for biomarker assessment.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score ≤ 1.
You likely can't join if
- Squamous cell or undifferentiated or other histological type gastric cancer (GC)
- Active leptomeningeal disease or uncontrolled brain metastasis. Patients with equivocal findings or with confirmed brain metastases are eligible for...
- Diagnosis with gastric or GEJ adenocarcinoma with positive human epidermal growth factor receptor 2 (HER2).
- Active autoimmune diseases or history of autoimmune diseases that may relapse.
- Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (at least once a week) and/or diuretics within 7 days...
See the full eligibility criteria
- Histologically confirmed, locally advanced unresectable or metastatic gastric/ gastroesophageal junction (GEJ) adenocarcinoma.
- No previous systemic therapy for locally advanced unresectable or metastatic gastric/GEJ cancer.
- At least 1 measurable or nonmeasurable lesion per RECIST v1.1 as determined by investigator assessment.
- Must be able to provide tumor tissues for biomarker assessment.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score ≤ 1.
- Adequate organ function.
- 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.
- 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.
- Squamous cell or undifferentiated or other histological type gastric cancer (GC)
- 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...
- Diagnosis with gastric or GEJ adenocarcinoma with positive human epidermal growth factor receptor 2 (HER2).
- Active autoimmune diseases or history of autoimmune diseases that may relapse.
- Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (at least once a week) and/or diuretics within 7 days prior to randomization NOTE: Other protocol defined Inclusion/Exclusion...
The study team makes the final eligibility decision.
Where it's taking place
- Chandler, Arizona, United States
- Los Alamitos, California, United States
- Colorado Springs, Colorado, United States
- Hialeah, Florida, United States
- Orlando, Florida, United States
- Chicago, Illinois, United States
- Hinsdale, Illinois, United States
- Kansas City, Kansas, United States
- Westbrook, Maine, United States
- Bridgeton, Missouri, United States
- Lincoln, Nebraska, United States
- Las Vegas, Nevada, United States
- Flemington, New Jersey, United States
- Florham Park, New Jersey, United States
- Salem, Oregon, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Temple, Texas, United States
- Tacoma, Washington, United States
- CABA, Argentina
+ 72 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chandler, Arizona, United States; Los Alamitos, California, United States; Colorado Springs, Colorado, United States; Hialeah, Florida, United States; Orlando, Florida, United States; Chicago, Illinois, United States and 86 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.