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Trial ID CA266-0004  |   NCT07221149

A Study 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

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Summary

  • Phase 2/Phase 3
  • Male and Female Gender icon
  • 18+
    Age Range
  • 71
    Locations
  • BMS Not Yet Recruiting Study icon
    Not Yet Recruiting

Overview

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

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
  • Participants 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.
    1. Participants must have a documented programmed cell death-(ligand)1 (PD-L1) ≥ 1.
      1. Participants must have documented human epidermal growth factor receptor 2 (HER2)-negative cancer, as determined according to local guidelines.
        1. Participants must have measurable disease as defined by RECIST v1.1.

          Exclusion Criteria

          Exclusion Criteria Icon
          • Participants must not have untreated known central nervous system (CNS) metastases.
            1. Participants must not have significant cardiovascular disease, such as myocardial infarction, unstable angina, arterial thrombosis, cerebrovascular accident within 6 months prior to randomization, uncontrolled hypertension (≥ 160 systolic, ≥ 100 diastolic mm Hg) despite optimal medical management, or congenital long QT syndrome.
              1. Participants must not have evidence of major coagulation disorders (eg, hemophilia).
                1. Participants 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 prophylactic dose.
                  1. Participants must not have a history of abdominal fistula or gastrointestinal (GI) perforation within 6 months of randomization.
                    1. Participants 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.
                      Additional Information *
                      • Other protocol-defined Inclusion/Exclusion criteria apply.

                        Treatment Options

                        Study Arms

                        ASSIGNED INTERVENTION

                        Study Arms

                        Experimental: Arm A1

                        ASSIGNED INTERVENTION

                        Study Arms

                        Experimental: Arm A2

                        ASSIGNED INTERVENTION

                        Study Arms

                        Experimental: Arm B

                        ASSIGNED INTERVENTION

                        Study Arms

                        Experimental: Arm C

                        ASSIGNED INTERVENTION

                        Study Arms

                        Experimental: Arm D

                        ASSIGNED INTERVENTION
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