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ROSETTA Gastric-204: A Blinded, Randomized, Phase II/III Study of Pumitamig in Combination with Chemotherapy Versus Nivolumab in Combination with Chemotherapy in Participants with Previously Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma

UCI Specialty Area: Cancer
Principal Investigator: Farshid Dayyani
A Study On:
Esophagus
Stomach

Study Description

The purpose of this study is to evaluate the safety and efficacy of Pumitamig in combination with chemotherapy versus Nivolumab in combination with chemotherapy in participants with previously untreated advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma

Eligibility

-You must be previously untreated with systemic treatment for advanced/metastatic disease, histologically or cytologically confirmed advanced or metastatic gastric cancer (GC), gastroesophageal junction adenocarcinoma (GEJC) or distal esophageal adenocarcinoma (EAC). GEJ involvement can be confirmed via biopsy, endoscopy, or imaging.

-You must have documented human epidermal growth factor receptor 2 (HER2)-negative cancer, as determined according to local guidelines.

Participants must have measurable disease as defined by RECIST v1.1.

-You must not have untreated known central nervous system (CNS) metastases.

-You must not have evidence of major coagulation disorders (eg, hemophilia).

-You must not have a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism within 3 months prior to randomization, unless the participant has been fully treated (eg, inferior vena cava filter placed) and/or adequately anticoagulated on a stable dose.

-You must not have a history of abdominal fistula or gastrointestinal (GI) perforation within 6 months of randomization.

-You must not have had major surgery, open biopsy, or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of study intervention.

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Privacy Policy

University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Eric Vilain, MD, PhD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

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  • Future Research Use
    Researchers will use your information to conduct this study. Once the study is done using your information, we may share them with other researchers so they can use them for other studies in the future. We will not share your name or any other private identifiable information that would let the researchers know who you are. We will not ask you for additional permission to share this de-identified information
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