Evaluating a New Treatment for Advanced Stomach or Esophageal Cancer

Recruiting · Phase 2/Phase 3 · Advanced Esophageal Adenocarcinoma and related conditions · 41 states

Check if I qualify View on ClinicalTrials.gov

About this trial

This clinical trial looks at adding a medicine called nivolumab to the usual treatment of paclitaxel and ramucirumab for people with advanced stomach or esophageal cancer. The goal is to see if this new combination helps patients live longer without their cancer getting worse. This study is part of a larger effort to find better treatments for these types of cancer.

This is a Phase 2/3 trial, which means it is looking at how well the treatment works and how safe it is. The trial is FDA-regulated and hopes to include about 224 participants.

Who can join

Adults aged 18 and older can join this study. It is open to both men and women who have advanced stomach or esophageal cancer that cannot be removed by surgery. Participants must also have a specific test result showing their cancer may respond to treatment. The trial team will check to see who is eligible to join.

Conditions

Advanced Esophageal Adenocarcinoma, Advanced Gastric Adenocarcinoma, Advanced Gastroesophageal Junction Adenocarcinoma, Clinical Stage II Esophageal Adenocarcinoma AJCC v8, Clinical Stage III Esophageal Adenocarcinoma AJCC v8, Clinical Stage III Gastric Cancer AJCC v8, Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage IV Esophageal Adenocarcinoma AJCC v8, Clinical Stage IV Gastric Cancer AJCC v8, Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8, Metastatic Esophageal Adenocarcinoma, Metastatic Gastric Adenocarcinoma, Metastatic Gastroesophageal Junction Adenocarcinoma, Unresectable Esophageal Adenocarcinoma, Unresectable Gastric Adenocarcinoma, Unresectable Gastroesophageal Junction Adenocarcinoma

Age group

Adult, Older adult

Sex

All sexes

The study team makes the final call on eligibility.

What happens in the study

Participants will be randomly placed into one of two groups. One group will receive nivolumab along with paclitaxel and ramucirumab. The other group will receive just paclitaxel and ramucirumab. Everyone will receive treatment for cycles of 28 days, and scans will be done to monitor progress. Some participants may also provide blood samples during the study.