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

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

Trial Details

NCT ID
NCT06203600
Phase
PHASE2 / PHASE3
Sponsor
National Cancer Institute (NCI)
Status
RECRUITING
Cancer Type
Adenocarcinoma Esophageal Cancer
Interventions
  • Biospecimen Collection
  • Computed Tomography
  • Magnetic Resonance Imaging
  • Nivolumab
  • Paclitaxel
  • Questionnaire Administration
Locations (sample)
  • Little Rock, Arkansas, United States|34.74648,-92.28959
  • Anaheim, California, United States|33.83529,-117.9145
  • Newport Beach, California, United States|33.61891,-117.92895
  • Colorado Springs, Colorado, United States|38.83388,-104.82136
  • Fort Collins, Colorado, United States|40.58526,-105.08442

Key Eligibility Criteria

  • Participants must have advanced or locally unresectable gastric, gastroesophageal junction or esophageal adenocarcinoma
  • Participants must have PD-L1 CPS (Combined Positive Score) ≥ 1. This test would have been performed as part of standard of care (SOC) pathology tes…
  • Participants must have a histologically confirmed diagnosis of microsatellite stable (MSS) and HER2 negative gastric, gastroesophageal junction, or…
  • Participants must have documented unresectable and/or metastatic disease on CT or MRI imaging completed prior to registration. Imaging must have be…

For full eligibility, visit ClinicalTrials.gov.

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