Study on Adding Nivolumab to Standard Treatment for Advanced Stomach or Esophageal Cancer (PARAMUNE Trial)

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06203600

Provider View

This clinical trial is testing whether adding the immunotherapy drug nivolumab to the usual treatment of paclitaxel and ramucirumab can improve outcomes for patients with advanced stomach or esophageal cancer.

Patient Parameters

Program Overview

This study is exploring if adding the immunotherapy drug nivolumab to the standard treatment of paclitaxel and ramucirumab can better control advanced stomach or esophageal cancer. Nivolumab is a type of immunotherapy that may help the immune system attack cancer cells. Ramucirumab is a drug that may stop tumors from growing new blood vessels, and paclitaxel is a chemotherapy drug that can kill cancer cells. The trial aims to see if this combination can improve survival and control the disease better than the standard treatment alone.

Description

The study is divided into two phases: Phase II and Phase III. In Phase II, researchers will see if adding nivolumab to paclitaxel and ramucirumab improves the time patients live without the cancer getting worse. If successful, Phase III will focus on whether this combination helps patients live longer overall.

Secondary goals include comparing how well the cancer responds to treatment, the safety of the treatments, and the quality of life of patients receiving the different treatments. Patients will be randomly assigned to one of two groups:

  • Group 1: Receives nivolumab, ramucirumab, and paclitaxel.
  • Group 2: Receives only ramucirumab and paclitaxel.

Both groups will receive their treatments in cycles, with regular scans to monitor the cancer. After treatment, patients will have follow-up visits to check their health and the cancer's status.

The study will also look at how the treatments affect patients' quality of life and any side effects they experience.

Eligibility Criteria

Inclusion Criteria

  • Have advanced or inoperable stomach, gastroesophageal junction, or esophageal cancer.
  • Have a PD-L1 CPS score of 1 or higher from a recent test.
  • Have a confirmed diagnosis of microsatellite stable and HER2 negative cancer.
  • Have cancer that cannot be removed by surgery or has spread, confirmed by recent scans.
  • Have no signs of brain metastases progression after treatment.
  • Have tried standard chemotherapy with or without immunotherapy and it did not work or was not tolerated.
  • Have not had more than one previous systemic therapy.
  • Be 18 years or older.
  • Have a performance status score of 0-2, indicating good overall health.
  • Have adequate blood counts and organ function based on recent tests.
  • Not have any major surgeries planned during the trial.
  • Not have any active bleeding or recent history of severe gastrointestinal issues.
  • Not be pregnant or nursing and agree to use effective contraception if of reproductive potential.
  • Not have any other serious medical conditions that could interfere with the study.
  • Be able to understand and sign informed consent, or have a representative do so if needed.

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