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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 (PARAMUNE)

Objective

Phase II: To assess whether progression-free survival (PFS) is sufficiently improved in participants randomized to nivolumab + paclitaxel + ramucirumab compared to those randomized to paclitaxel + ramucirumab to warrant a Phase III study with overall survival (OS) as the primary endpoint. Phase III: To compare OS in participants randomized to nivolumab + paclitaxel + ramucirumab versus those randomized to paclitaxel + ramucirumab.

Protocol #

S2303

Trial Phase:

Phase II/III

Principal Investigator:

Myers, Jennifer

Cancer Type
  • Esophagus
  • Stomach
Study Site
  • Stony Point
  • Virginia Commonwealth University

Participants must have advanced or locally unresectable gastric, gastroesophageal junction or esophageal adenocarcinoma
Participants must have PD-L1 CPS (Combined Positive Score) >/= 1
Participants must have a histologically confirmed diagnosis of 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
Participants must be >/= 18 years old

Get more detailed information at ClinicalTrials.gov

  • Enrollment Status 1
  • Age Group Adult
  • Protocol Type Treatment
  • Research Study Team Carrie Donovan, RN
    Phone: +1 804-628-3836
    Email Study Contact

Click "I'm Interested" to get started. If you have questions, call our study contact.

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