Pembrolizumab, Combination Chemotherapy, and Radiation Therapy Before Surgery in Treating Adult Patients With Locally Advanced Gastroesophageal Junction or Gastric Cardia Cancer That Can Be Removed by Surgery

Summary

This phase Ib/II trial studies the side effects and best way to give pembrolizumab with combination chemotherapy and radiation therapy before surgery and to see how well it works in treating adult patients with gastroesophageal junction or gastric cardia cancer that has spread from where it started to nearby tissue and can be removed by surgery. Monoclonal antibodies, such as pembrolizumab, may block tumor growth in different ways by targeting certain cells. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving pembrolizumab, combination chemotherapy, and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Conditions

• Gastric Cardia Adenocarcinoma
• Gastroesophageal Junction Adenocarcinoma
• Stage IB Gastric Cancer AJCC v7
• Stage II Gastric Cancer AJCC v7
• Stage IIA Gastric Cancer AJCC v7
• Stage IIB Gastric Cancer AJCC v7
• Stage IIIA Gastric Cancer AJCC v7
• Stage IIIB Gastric Cancer AJCC v7

Interventions

DRUG

Carboplatin

Given IV

PROCEDURE

Computed Tomography

Undergo CT scan

DRUG

Fluorouracil

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Leucovorin Calcium

Given IV

DRUG

Oxaliplatin

Given IV

DRUG

Paclitaxel

Given IV

BIOLOGICAL

Pembrolizumab

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET scan

RADIATION

Radiation Therapy

Undergo radiation therapy

PROCEDURE

Therapeutic Conventional Surgery

Undergo curative-intent surgery

Sponsors & Collaborators

• Mayo Clinic

  lead OTHER

Principal Investigators

• Harry H. Yoon, M.D. · Mayo Clinic

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-06-24

Primary Completion

2021-07-01

Completion

2023-10-31

FDA Drug

Yes

Countries

• United States

Study Locations