Adding Nivolumab to Usual Treatment for People With Advanced Stomach or Esophageal Cancer, PARAMUNE Trial

Summary

This phase II/III trial compares the addition of nivolumab to the usual treatment of paclitaxel and ramucirumab to paclitaxel and ramucirumab alone in treating patients with gastric or esophageal adenocarcinoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Adding nivolumab to ramucirumab and paclitaxel may work better to treat patients with advanced stomach or esophageal cancer.

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

Interventions

PROCEDURE

Biospecimen Collection

Undergo optional blood sample collection

PROCEDURE

Computed Tomography

Undergo CT scan

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

BIOLOGICAL

Nivolumab

Given IV

DRUG

Paclitaxel

Given IV

OTHER

Questionnaire Administration

Ancillary studies

BIOLOGICAL

Ramucirumab

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Anwaar Saeed · SWOG Cancer Research Network

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-06-24

Primary Completion

2027-10-31

Completion

2027-10-31

FDA Drug

Yes

Countries

• United States

Study Locations