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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 is a Phase 2 study that has completed, run by Duke University. The registered enrollment target is 36 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03342937
The ClinicalTrials.gov registry entry for NCT03342937 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Oxaliplatin+Capecitabine+Pembrolizumab is the first listed.
NCT03342937 reports 0 study locations.
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.
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