KeyLargo: Pembrolizumab + Oxaliplatin + Capecitabine in Gastric Cancer
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|ClinicalTrials.gov Identifier: NCT03342937|
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : March 29, 2019
This study will be conducted in two stages: 1) safety validation and 2) dose expansion
- 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.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer Esophagus Cancer||Drug: Oxaliplatin+Capecitabine+Pembrolizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single Arm, Phase II Study of Pembrolizumab, Oxaliplatin, and Capecitabine in the First Line Treatment of Patients With Gastro-esophageal Cancer.|
|Actual Study Start Date :||January 11, 2018|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
For each cycle: Oxaliplatin 130 mg/m2 IV on Day1, Capecitabine 825 or 1000 mg/m2 PO, BID Days on Days1-14, Pembrolizumab 200 mg IV on Day 1.
This study has 2 parts:
- Progression-free survival (PFS) as measured by documented progression or death from any cause. [ Time Frame: Up to 2 years ]
- Over all survival as measured by follow up [ Time Frame: Up to 2 years ]
- Number of adverse events [ Time Frame: From the first dose of study drug through 30 days after the last dose of study drug ]All grade 2-5 Adverse events must be recorded on the case report form (CRF)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03342937
|Contact: Taylor Kennedy Frenchifirstname.lastname@example.org|
|Contact: Ireka Burrus, MSWemail@example.com|
|United States, North Carolina|
|Duke Cancer Center, Duke Uniersity||Recruiting|
|Durham, North Carolina, United States, 27710|
|Principal Investigator: Hope Uronis, MD|
|Principal Investigator:||Hope Uronis, MD||Duke University|