drugset / Trial / NCT02730546

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

NCT02730546

Phase 1/2 Completed 31 enrolled Mayo Clinic
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2016-06-24
Primary completion
2021-07-01
Completion
2023-10-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Pembrolizumab Monoclonal antibody Intravenous
Background Carboplatin Small molecule Intravenous
Background Leucovorin Small molecule Intravenous
Background Oxaliplatin Small molecule Intravenous
Background Paclitaxel Small molecule Intravenous
Background fluorouracil Small molecule Intravenous