Nivolumab + Paclitaxel + Ramucirumab in Advanced Gastric and Esophageal Adenocarcinoma

What is the Purpose of this Study?

This study focuses on people who have advanced stomach or esophageal cancer that has spread. The purpose of the study is to compare the usual treatment alone (the combination of 2 drugs, paclitaxel and ramucirumab) to the usual treatment plus a drug called nivolumab. The addition of nivolumab to the usual treatment could stop the cancer from spreading, but it may also cause side effects. Researchers aim to determine whether patients experience a longer, shorter, or same amount of time without the disease getting worse (progression) than patients taking the standard treatment alone, as well as whether they live longer with the addition of nivolumab. Participants will be randomly assigned to 1 of 2 groups. Group 1 will receive paclitaxel, ramucirumab, and nivolumab (the usual treatment plus nivolumab); Group 2 will receive paclitaxel and ramucirumab alone. While paclitaxel and ramucirumab are approved by the U.S. Food and Drug Administration, the combined use of paclitaxel, ramucirumab, and nivolumab is considered experimental.


Eligibility

  • * 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 testing, using tissue obtained within two years prior to registration and collected prior to or after a frontline regimen
  • * Participants must have a histologically confirmed diagnosis of microsatellite stable (MSS) and HER2 negative gastric, gastroesophageal junction, or esophageal adenocarcinoma
  • * Participants must have documented unresectable and/or metastatic disease on CT or MRI imaging completed prior to registration. Imaging must have been completed within 28 days prior to registration for participants with measurable disease. CT scans or MRIs used to assess non-measurable disease must have been completed within 42 days prior to registration. All disease must be assessed and documented on the Baseline Tumor Assessment Form
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Where can I participate?

CS Cancer at Cedars-Sinai Medical Center : Abrahm Levi

More about this Clinical Trial

What is the full name of this clinical trial?

S2303: Randomized Phase II/III Trial of 2nd Line Nivolumab + Paclitaxel + Ramucirumab versus Paclitaxel + Ramucirumab in Patients with PD-L1 CPS; 1 Advanced Gastric and Esophageal Adenocarcinoma

Study Details
Disease Type/Condition

Esophagus, Stomach

Principal Investigator

Gong, Jun

Co-Investigators

Andrew Hendifar, Arsen Osipov

Age Group

Adult

Phase

II/III

IRB Number

STUDY00004013

ClinicalTrials.gov ID

NCT06203600

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Name

Abrahm Levi

Email
Abrahm.Levi@cshs.org
Study Detail
Disease Type/Condition

Esophagus, Stomach

Principal Investigator

Gong, Jun

Age Group

Adult

Phase

II/III

IRB Number

S2303

ClinicalTrials.gov ID

NCT06203600

Key Eligibility
ClinicalTrials.gov

Contact
Name

Abrahm Levi

Email
Abrahm.Levi@cshs.org