Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Esophageal Neoplasms

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Head and Neck Neoplasms

Esophageal Diseases

Esophageal Cancer

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Oxaliplatin

Capecitabine

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Antimetabolites

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:

1. Safety validation part: all Cycles are 21 days in length.
2. Dose Expansion part: Cycle 1 is 28 days in length. Cycle 2 and beyond are 21 days.

Oxaliplatin+Capecitabine+Pembrolizumab

Hope Uronis, MD

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.

KeyLargo: Pembrolizumab + Oxaliplatin + Capecitabine in Gastric Cancer

A Single Arm, Phase II Study of Pembrolizumab, Oxaliplatin, and Capecitabine in the First Line Treatment of Patients With Gastro-esophageal Cancer.

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 PFS will be estimated using the Kaplan-Meier method.

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.

Overall survival is the amount of time subjects live since starting the study.

Merck Sharp & Dohme LLC

Duke University

All grade 2-5 adverse events will be recorded in the study database. The safety run-in was intended to identify dose-limiting toxicity. No DLTs were observed in the safety run-in and the drug dose levels were not changed in the expansion cohort, therefore; results were for safety validation and expansion were combined.

For each cycle: Oxaliplatin 130 mg/m2 IV on Day1, Capecitabine 825 or 1000 mg/m2 PO, BID Days on Days 1-14, Pembrolizumab 200 mg IV on Day 1.

Safety validation: all Cycles are 21 days in length. Dose Expansion: Cycle 1 is 28 days in length. Cycle 2 and beyond are 21 days.

Oxaliplatin + Capecitabine + Pembrolizumab

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

The safety run-in was intended to identify dose-limiting toxicity. No DLTs were observed in the safety run-in and the drug dose levels were not changed in the expansion cohort, therefore; results were for safety validation and expansion were combined.

Dr. Hope Uronis

The safety run-in was intended to identify dose-limiting toxicity. No DLTs were observed in the safety run-in and the drug dose levels were not changed in the expansion cohort, therefore; results were for safety validation and expansion were combined. One treated patient did not complete cycle 1 of therapy.

Months of Progression-free Survival (PFS)

Treated patients with at least 1 re-staging. The safety run-in was intended to identify dose-limiting toxicity. No DLTs were observed in the safety run-in and the drug dose levels were not changed in the expansion cohort, therefore; results were for safety validation and expansion were combined.

Response Rate as Measured by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

Months of Overall Survival

For each cycle: Oxaliplatin 130 mg/m2 IV on Day1, Capecitabine 825 or 1000 mg/m2 PO, BID Days on Days 1-14, Pembrolizumab 200 mg IV on Day 1.

Safety validation: all Cycles are 21 days in length. Dose expansion: Cycle 1 is 28 days. Cycle 2 and beyond are 21 days.

Spots Global Cancer Trial Database for oxaliplatin+capecitabine+pembrolizumab