18 and older, any sex, with Gastric Cancer or Esophagus Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Months of Progression-free Survival (PFS)Primary· Up to 44 months
PFS measured from study entry until documented progression or death from any cause. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. Patients who have not experienced progression will be censored at the date of the last radiographic assessment. The median
Group
Value
95% CI
Oxaliplatin + Capecitabine + Pembrolizumab
7.6
5.8 – 11.2
Response Rate as Measured by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)Secondary· Up to 44 months
Response rate is calculated as the number of people with a complete response or partial response, divided by the total number of people treated. Complete response is defined as disappearance of all target lesions. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Group
Value
95% CI
Oxaliplatin + Capecitabine + Pembrolizumab
0.76
0. – 0.90
Months of Overall SurvivalSecondary· Up to 44 months
Overall survival is the amount of time subjects live since starting the study.
Group
Value
95% CI
Oxaliplatin + Capecitabine + Pembrolizumab
16
11.6 – 24.3
Adverse events — posted to ClinicalTrials.gov
Time frame: From the first dose of study drug through 30 days after the last dose of study drug (up to 44 months)..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Oxaliplatin + Capecitabine + Pembrolizumab
Serious: 17/36 (47%)
Deaths: 26/36
Serious adverse events (24 terms)
Reaction
System
Oxaliplatin + Capecitabine…
Colitis
Gastrointestinal disorders
—
Vomiting
Gastrointestinal disorders
—
Colonic obstruction
Gastrointestinal disorders
—
Diarrhea
Gastrointestinal disorders
—
Dysphagia
Gastrointestinal disorders
—
Nausea
Gastrointestinal disorders
—
Dehydration
Metabolism and nutrition disorders
—
Hyperglycemia
Metabolism and nutrition disorders
—
Thromboembolic event
Vascular disorders
—
Pericardial tamponade
Cardiac disorders
—
Sinus tachycardia
Cardiac disorders
—
Abdominal pain
Gastrointestinal disorders
—
Ascites
Gastrointestinal disorders
—
Constipation
Gastrointestinal disorders
—
Sudden death NOS
General disorders
—
Device related infection
Infections and infestations
—
Enterocolitis infectious
Infections and infestations
—
Infections and infestations - Other, Specify
Infections and infestations
—
Lung infection
Infections and infestations
—
Meningitis
Infections and infestations
—
Sepsis
Infections and infestations
—
Aspartate aminotransferase increased
Investigations
—
Bone pain
Musculoskeletal and connective tissue disorders
—
Pleural effusion
Respiratory, thoracic and mediastinal disorders
—
Other adverse events (124 terms — click to expand)
This study will be conducted in two stages: 1) safety validation and 2) dose expansion
1. Safety Validation Cohort: The first portion of the study will preliminarily establish the tolerability of the combination of pembrolizumab, oxaliplatin and capecitabine. Five (5) subjects will be enrolled and their safety data after 21 days of treatment will be reviewed before additional subjects are enrolled. Subjects on this portion of the study will only be enrolled at the Duke Cancer Institute.
2. Dose Expansion Cohort: The second portion of the study (ie. phase II) will enroll 30 subjects. In the dose expansion cohort, the first cycle will be modified to allow one week of pembrolizumab monotherapy before starting capecitabine and oxaliplatin (XELOX) chemotherapy, which will allow analysis of biomarkers related to pembrolizumab. Subjects on this portion of the study will be enrolled at the Duke Cancer institute and select external collaborating institutions.
The primary objective of this trial is to describe the progression free survival (PFS) associated with the combination of pembrolizumab, oxaliplatin and capecitabine (pembrolizumab +XELOX) in all patients with previously untreated metastatic esophagogastric adenocarcinoma.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07525765 — AI-assisted Decision-making of Reoperation for Postoperative Bleeding of Gastric Cancer
· recruiting
NCT07464470 — Comparison of Molecular-Genetic Concordance of the Primary Tumor and Brain Metastases of Gastroesophageal Cancers
· recruiting
NCT07432633 — [18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications
· Phase 1, PHASE2
· recruiting
NCT07431281 — Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Meta
· Phase 3
· recruiting
NCT07448493 — Local Treatment Strategies for Brain Metastases of Gastric and Esophageal Cancer
· active not recruiting
Other Duke University trials
Trials by the same sponsor.
NCT07216456 — Vaginal Dilator Therapy After Pelvic Radiation
· NA
· not yet recruiting
NCT07519317 — Dosing and Deployment Trial: A Home-based Optokinetic Treatment
· NA
· not yet recruiting
NCT07275359 — Investigating Senolytic Properties in Pulmonary Rehabilitation and Metformin in COPD Exacerbations
· Phase 1
· not yet recruiting
NCT07216963 — The Community Paramedic Response and Overdose Outreach With Supportive Medical-Legal Services Study
· NA
· not yet recruiting
NCT07459218 — IDEAS for Hope to Reduce Suicide Risk and Improve HIV Care Engagement in Tanzania
· NA
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Duke University
Last refreshed: 13 March 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03342937.