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A Study of Zolbetuximab Together with Pembrolizumab and Chemotherapy in Adults with Gastric Cancer
EU CTIS ID: 2024-519773-19-00
What this study is testing
To evaluate the efficacy of zolbetuximab plus pembrolizumab and chemotherapy (CAPOX or mFOLFOX6) compared with placebo plus pembrolizumab and chemotherapy (CAPOX or mFOLFOX6) (as first-line treatment)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participant is ≥ 18 years of age at the time of signing informed consent.
- Participant’s tumor expresses PD-L1 CPS ≥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 set forth in this protocol.
- Participant has histologically confirmed gastric or gastroesophageal 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 RECIST V1.1, per investigator assessment, ≤ 28 days prior to randomization. For participants with only 1 evaluable lesion and prior radiotherapy ≤ 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 Cooperataive Oncology Group performance status 0 to 1.
You likely can't join if
- Participant has prior severe allergic reaction or intolerance to (zolbetuximab or other monoclonal antibodies, pembrolizumab, mFOLFOX6 or CAPOX).
- Participant has another malignancy for which treatment is required, per investigator’s clinical judgment.
- Participant has known dihydropyrimidine dehydrogenase deficiency (screening for dihydropyrimidine dehydrogenase deficiency should be conducted per local requirements). For EU-specific requirements, refer to section 10.9.1 of the protocol.
- 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 known as veno-occlusive disease, if present, should be stable or improving per investigator’s judgment.
- Participant has significant cardiovascular disease, including any of the following: a. Congestive heart failure (defined as New York Heart Association Class III or IV), myocardial infarction, unstable angina, coronary angioplasty, coronary stenting, coronary artery bypass graft, cerebrovascular accident or hypertensive crisis within 6 months prior to randomization. b. History of clinically significant ventricular arrhythmias (i.e., sustained; ventricular tachycardia, ventricular fibrillation, or Torsades de Pointes). c. QTc interval > 450 msec for male participants; QTc interval > 470 msec for female participants. d. History or family history of congenital long QT syndrome. e. Cardiac arrhythmias requiring anti-arrhythmic medications (participants with rate controlled atrial fibrillation for > 1 month prior to randomization are eligible).
See the full eligibility criteria
Who can join
- Participant is ≥ 18 years of age at the time of signing informed consent.
- Participant’s tumor expresses PD-L1 CPS ≥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 set forth in this protocol.
- Participant has histologically confirmed gastric or gastroesophageal 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 RECIST V1.1, per investigator assessment, ≤ 28 days prior to randomization. For participants with only 1 evaluable lesion and prior radiotherapy ≤ 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 Cooperataive Oncology Group performance status 0 to 1.
- Participant has predicted life expectancy ≥ 12 weeks in the opinion of the investigator.
- Participant must be a candidate to receive mFOLFOX6 or CAPOX and pembrolizumab.
- Participant has a HER2-negative tumor.
- Participant’s tumor expresses CLDN18.2 in ≥ 75% of tumor cells demonstrating moderate to strong membranous staining as determined by central IHC testing.
What rules you out
- Participant has prior severe allergic reaction or intolerance to (zolbetuximab or other monoclonal antibodies, pembrolizumab, mFOLFOX6 or CAPOX).
- Participant has another malignancy for which treatment is required, per investigator’s clinical judgment.
- Participant has known dihydropyrimidine dehydrogenase deficiency (screening for dihydropyrimidine dehydrogenase deficiency should be conducted per local requirements). For EU-specific requirements, refer to section 10.9.1 of the protocol.
- 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 known as veno-occlusive disease, if present, should be stable or improving per investigator’s judgment.
- Participant has significant cardiovascular disease, including any of the following: a. Congestive heart failure (defined as New York Heart Association Class III or IV), myocardial infarction, unstable angina, coronary angioplasty, coronary stenting, coronary artery bypass graft, cerebrovascular accident or hypertensive crisis within 6 months prior to randomization. b. History of clinically significant ventricular arrhythmias (i.e., sustained; ventricular tachycardia, ventricular fibrillation, or Torsades de Pointes). c. QTc interval > 450 msec for male participants; QTc interval > 470 msec for female participants. d. History or family history of congenital long QT syndrome. e. Cardiac arrhythmias requiring anti-arrhythmic medications (participants with rate controlled atrial fibrillation for > 1 month prior to randomization are eligible).
- Participant has ongoing or previous interstitial lung disease, active diverticulitis or peptic ulcerative disease, or solid organ or stem cell transplant or other uncontrolled or clinically significant medical disorders.
- Participant has type 1 diabetes mellitus, endocrinopathies stably maintained on appropriate replacement therapy or skin disorders (e.g., vitiligo, psoriasis or alopecia) not requiring systemic treatment are allowed
- This criterion has been removed
- 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 per investigator’s judgment.
- 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/gastroesophageal junction cancer.
- Participant has a known history of a positive test for HIV infection or known active hepatitis B (positive HBsAg) or hepatitis C infection. NOTE: Screening for these infections should be conducted per local requirements.
- 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.
- Participant has a clinically significant disease or comorbidity that in the opinion of the investigator may adversely affect the safe delivery of treatment within this study or make the participant unsuitable for study participation.
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- United Kingdom
- China
- Mexico
- Taiwan
- Turkey
- Australia
- Korea, Republic of
- Brazil
- United States
- Chile
- Japan
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; United Kingdom; China; Mexico; Taiwan; Turkey and 6 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 EU CTIS; the study team decides eligibility.