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NCT03342937 · ClinicalTrials.gov registry record · Phase 2
KeyLargo: Pembrolizumab + Oxaliplatin + Capecitabine in Gastric Cancer
A Phase 2 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
NCT03342937: Completed Phase 2 study, sponsored by Duke University.
NCT03342937 is a Phase 2 study that has completed, run by Duke University. The registered enrollment target is 36 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03342937, a Phase 2 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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
Interventions
- DRUG Oxaliplatin+Capecitabine+Pembrolizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2018-01-11 |
| Est. Completion | 2023-02-06 |
| Phase | Phase 2 |
What the finished NCT03342937 record still lists
NCT03342937 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 1 intervention - of which Oxaliplatin+Capecitabine+Pembrolizumab is the first listed.
NCT03342937 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03342937 about?
NCT03342937 is a clinical study titled "KeyLargo: Pembrolizumab + Oxaliplatin + Capecitabine in Gastric Cancer". 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 ...
What is the current status of trial NCT03342937?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2018-01-11. Estimated completion is 2023-02-06.
What interventions are being tested in trial NCT03342937?
The interventions under investigation include: Oxaliplatin+Capecitabine+Pembrolizumab (DRUG).
Who is sponsoring clinical trial NCT03342937?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03342937's enrollment target sits among peer trials
36 1496th of 2000 higher than 477 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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