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EA2174


Title A Phase II/III Study of Peri-operative Nivolumab and Ipilimumab in Patients with Locoregional Esophageal and Gastroesophageal Junction Adenocarcinoma
Therapeutic Area Esophageal Cancer
Principal Investigator Jacob Eklon, MD
Min Age 18 Years
Gender Both
Contact NCCCR Staff
617-636-3264
NCCCR@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT03604991?term=NCT03604991&draw=2&rank=1

Overview

This study is being done to answer the following questions:

  1. What are the good and bad effects of using usual chemotherapy and radiation plus the immunotherapy, nivolumab, before standard surgery for your condition?
  2. What are the good and bad effects of adding the immunotherapy nivolumab versus adding nivolumab and ipilimumab after standard surgery for your condition?

This study is being done to find out if these approaches are better or worse than the usual approach for locoregional esophageal or gastroesophageal junction adenocarcinoma.

Study Details

Inclusion Criteria

1. Patients must have histologically confirmed T1N1-3M0 or T2-3N0-2M0 esophageal or gastroesophageal junctional adenocarcinoma
2. Patients must have an ECOG Performance Status 0-1.
3. Patents must be deemed a surgical candidate by a thoracic surgeon, surgical oncologist, or surgeon who is qualified to perform an esophagectomy.
 

Exclusion Criteria

1. Patients may not have received prior chemotherapy or radiation therapy for management for this malignancy.
2. Patients may not have received prior immunotherapy for management of this malignancy or for any other past malignancy.
3. Patients must have no contraindication to receiving either carboplatin or paclitaxel chemotherapy
 

Study Requirements

Subjects will either get chemotherapy and radiation for up to 2 months followed by surgery, or get chemotherapy, radiation, and a drug called nivolumab for up to 2 months followed by surgery.

Then, following surgery, subjects will either receive nivolumab therapy for 6 months or nivolumab plus another drug called ipilimumab for 6 months.

After finishing treatment, subjects will visit the clinic once every 3 months for two years, then every 6 months for a total of up to 7 years after your surgery.