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โ† Trials
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A Study of Zolbetuximab Together With Pembrolizumab and Chemotherapy in Adults With Gastric Cancer

RecruitingPhase 3Ages 18 Years - anyAllAstellas Pharma Global Development, Inc.
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In plain words

What the trial is, and whether it could suit you

Zolbetuximab is being studied in people with cancer in and around the stomach or where the food pipe (esophagus) joins the stomach, called gastroesophageal junction (GEJ) cancer. Zolbetuximab with chemotherapy may be used to treat stomach and GEJ cancer when the cancer cells do not have a protein called HER2 (human epidermal growth factor receptor 2) on their surface (HER2-negative) but do have a protein called Claudin 18.2 (Claudin 18.2-positive). Zolbetuximab is thought to work by attaching to the Claudin 18.2 protein in their tumor, which switches on the body's immune system to attack the tumor. Certain stomach and GEJ cancers may be treated with immunotherapy, which helps the body's immune system fight cancer. This study will give more information about how well zolbetuximab works when given with an immunotherapy medicine called pembrolizumab and chemotherapy. In this study, adults w

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Participant has histologically confirmed gastric or Gastroesophageal Junction (GEJ) adenocarcinoma. * Participant has radiographically confirmed, locally advanced, unresectable or metastatic disease within 28 days prior to randomization. * Participant has radiologically evaluable disease (measurable and/or nonmeasurable) according to Response Evaluation Criteria in Solid Tumors (RECIST) V1.1, โ‰ค 28 days prior to randomization. For participants with only 1 evaluable lesion and prior radiotherapy โ‰ค 3 months before randomization, the lesion must either be outside the field of prior radiotherapy or have documented progression following radiation therapy. * Participant has Eastern Cooperative Oncology Group Performance Status (ECOG) performance status 0 to 1. * Participant has predicted life expectancy โ‰ฅ 12 weeks. * Participant must be a candidate to receive mFOLFOX6 or CAPOX and pembrolizumab. * Female participant is not pregnant and at least 1 of the following conditions apply: * Not a woman of child bearing potential (WOCBP) * WOCBP who has a negative urine or serum pregnancy test at screening (Specific to Japan: with a medical interview), and agrees to follow the contraceptive guidance from the time of informed consent through at least 9 months after the final oxaliplatin administration and 6 months after the final administration of all other study interventions. * Female participant must not be breastfeeding or lactating starting at screening and throughout the investigational period and for 5 half-lives (at least 9 months after the final oxaliplatin administration and 6 months after the final administration of all other study interventions). * Female participant must not donate ova starting at first administration of study intervention and throughout the investigational period, and for 9 months after the final administration of oxaliplatin and for 6 months after final administration of all other study interventions. * Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period, and for 6 months after final investigational study intervention administration. * Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 6 months after the final investigational study intervention administration. * Male participant must not donate sperm during the treatment period and for 6 months after the final investigational study intervention administration * Participant has a Human Epidermal Growth Factor Receptor 2 (HER2) -negative tumor. * Participant's tumor expresses Claudin18.2 (CLDN18.2) in โ‰ฅ 75% of tumor cells demonstrating moderate to strong membranous staining as determined by central immunohistochemistry (IHC) testing. * Participant's tumor expresses Programmed death ligand (PD-L1) combined positive score (CPS) โ‰ฅ 1 as determined by central IHC testing. * Participants with known microsatellite instability-high or mismatch repair deficient status may enroll as long as they meet the PD-L1 positivity criteria. * Participant must meet all of the criteria based on the centrally or locally analyzed laboratory tests collected within 14 days prior to randomization. In case of multiple central laboratory data within this period, the most recent data should be used. * Participant agrees not to participate in another interventional study while receiving study intervention in the present study. Exclusion Criteria: * Participant has prior severe allergic reaction or intolerance to zolbetuximab or other monoclonal antibodies, pembrolizumab, mFOLFOX6 or CAPOX. * Participant has a complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent recurrent vomiting. * Participant has significant gastric bleeding and/or untreated gastric ulcers that would preclude the participant from participation. * Participant has unresolved pneumonitis or history of non-infectious pneumonitis such as immune-related pneumonitis, radiation induced pneumonitis. * Participant has history of central nervous system metastases and/or carcinomatous meningitis from gastric/GEJ cancer. * Participant has a known history of a positive test for Human Immunodeficiency Virus (HIV) infection or known active Hepatitis B Surface Antigen (positive HBsAg) or hepatitis C infection. NOTE: Screening for these infections should be conducted per local requirements. * For participants who are negative for HBsAg, but hepatitis B core antibody (HBcAb) positive, a hepatitis B DNA test will be performed and if positive the participant will be excluded. * Participants with positive Hepatitis C virus (HCV) serology, but negative HCV RNA test results are eligible. * Participants treated for HCV with undetectable viral load results are eligible. * Participant has active infection requiring systemic therapy that has not completely resolved within 7 days prior to randomization. * Participant has active autoimmune disease that has required systemic treatment within the past 3 months prior to randomization. Participants with stable autoimmune disease who are receiving physiologic replacement doses of hydrocortisone or its equivalent are allowed. * Participant has a clinically significant disease or comorbidity that may adversely affect the safe delivery of treatment within this study or make the participant unsuitable for study participation. * Participant has another malignancy for which treatment is required. * Participant has known complete Dihydropyrimidine Dehydrogenase (DPD) deficiency (screening for DPD deficiency should be conducted per local requirements). * Participant has known peripheral neuropathy \> grade 1 (absence of deep tendon reflexes as the sole neurological abnormality does not render the participant ineligible). * Participant has sinusoidal obstruction syndrome, formerly
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What it tests

  • zolbetuximab
  • Pembrolizumab
  • Capecitabine
  • Oxaliplatin
  • Folinic acid (leucovorin or local equivalent)
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Where

252 sites
UAB Medicine - UAB Hospital
Birmingham, United States
CBCC Global Research - Comprehensive Blood & Cancer Center
Bakersfield, United States
TOI Clinical Research
Cerritos, United States
University of California, San Diego Moores Cancer Center
La Jolla, United States
The Angeles Clinic and Research Institute, West Los Angeles Office
Los Angeles, United States
Hartford HealthCare - Hartford Hospital
Hartford, United States
Yale University School of Medicine
New Haven, United States
MedStar Georgetown University Hospital / Lombardi Comprehensive Cancer Center
Washington D.C., United States

โ€ฆand 244 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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