Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
study ends around

Description

Summary

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

Official Title

ROSETTA Gastric-204: A Blinded, Randomized, Phase 2/3 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

Keywords

Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma, Gastric Cancer, Gastroesophageal Junction Cancer, Esophageal Adenocarcinoma, Stomach Neoplasms, Adenocarcinoma Of Esophagus, Folfox protocol, Nivolumab, Pumitamig, Folfox, Capox

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.
  • Participants must have a documented programmed cell death-(ligand)1 (PD-L1) ≥ 1.
  • Participants 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 CAN'T join if...

  • Participants must not have untreated known central nervous system (CNS) metastases.
  • 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.
  • Participants must not have evidence of major coagulation disorders (eg, hemophilia).
  • 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.
  • Participants must not have a history of abdominal fistula or gastrointestinal (GI) perforation within 6 months of randomization.
  • 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.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Locations

  • Local Institution - 0240
    Los Angeles 5368361 California 5332921 90095 United States
  • Local Institution - 0277
    Orange 5379513 California 5332921 92868 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting
ID
NCT07221149
Phase
Phase 2/3 research study
Study Type
Interventional
Participants
Expecting 690 study participants
Last Updated