A Study of Pembrolizumab With Trastuzumab and Chemotherapy in People With Esophagogastric Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
The purpose of this study to find out whether adding trastuzumab and pembrolizumab to standard chemotherapy is an effective treatment for resectable HER2+ esophagogastric cancer.
Eligibility criteria
Qualifiers
Age 18 years or older at time of signing informed consent.
ECOG performance status 0-1.
HER2+ esophageal, GEJ, or gastric adenocarcinoma biopsy or resection specimen as defined by local HER2 IHC3+ or IHC 2+/FISH>2.0 expression.
Complete surgical resection of the primary tumor must be achievable
Disqualifiers
Presence of metastatic or recurrent disease.
Has received prior treatment for esophagogastric cancer
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 agent.
Has received prior therapy with an anti-HER2 agent
Trial design
Treatments tested in this trial
- Pembrolizumab
- Trastuzumab
- Oxaliplatin
- Capecitabine
- 5-Fluorouracil
- Docetaxel
- Nutrition questionnaires (optional)
- stool and saliva samples (optional)
Treatment groups
49 Participants
are divided into 1 treatment groupSponsors and collaborators
Memorial Sloan Kettering Cancer Center
Lead sponsor
Genentech, Inc.
Collaborator
Merck Sharp & Dohme LLC
Collaborator
Source ClinicalTrials.gov