A Study of Zolbetuximab Together With Pembrolizumab and Chemotherapy in Adults With Gastric Cancer

Recruiting Phase 3 Interventional Study
Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer Metastatic Gastric Adenocarcinoma or Cancer Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
500 (estimated)
Sponsor
Astellas Pharma Global Development, Inc. · Industry
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
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 evalua…
Contacts

Astellas Pharma Global Development Inc.

800-888-7704

astellas.registration@astellas.com

CONTACT