Recruiting 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 (ROSETTA Gastric-204)

Phase II / Phase III Interventional Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Pumitamig, Folfox, Capox, Nivolumab.
Who it may be relevant to: Registry conditions: Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Brazil, Canada +15
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

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

Interventions

Drug Pumitamig
Specified dose on specified days
Drug Folfox
Specified dose on specified days
Drug Capox
Specified dose on specified days
Drug Nivolumab
Specified dose on specified days

Primary outcome measures

Objective Response (OR) (confirmed complete response (CR) or partial response (PR)) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment [Time frame: Up to 2 years after the last participant is randomized]
Progression Free Survival (PFS) by RECIST v1.1 per blinded independent central review (BICR) [Time frame: Up to approximately 33 months]
Overall survival (OS) [Time frame: Up to approximately 47 months]

Secondary outcome measures (7)

PFS by RECIST v1.1 per investigator assessment [Time frame: Up to approximately 33 months]
Duration of Response (DOR) (CR or PR) by RECIST v1.1 per investigator assessment [Time frame: Up to approximately 33 months]
Time to Response (TTR) (CR or PR) by RECIST v1.1 per investigator assessment [Time frame: Up to approximately 33 months]
Disease control (Best Overall Response (BOR) of confirmed CR, confirmed PR, or Stable Disease (SD)) by RECIST v1.1 per investigator assessment [Time frame: Up to approximately 33 months]
Recommended dose of Pumitamig for Phase 3 [Time frame: Up to approximately 33 months]
Objective response (OR) by RECIST v1.1 per BICR [Time frame: Up to approximately 33 months]
DOR by RECIST v1.1 per BICR [Time frame: Up to approximately 33 months]

Eligibility criteria

Inclusion criteria

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 or < 1 status for Phase 2, and document PD-L1 ≥ 1 status for the Phase 3 part of the study.
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.

Exclusion criteria

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 stable 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Double blind
Primary purpose: Treatment

Study locations

United States · 34 centers

Local Institution - 0284 — Phoenix
Local Institution - 0437 — Los Angeles
University of California, Irvine (UCI) Health - UC Irvine Medical Center — Orange
Local Institution - 0428 — San Francisco
Florida Cancer Specialists - South — Fort Myers
Local Institution - 0433 — Jacksonville
Florida Cancer Specialists - North — St. Petersburg
Local Institution - 0246 — Tampa
… and 26 more centers

China · 22 centers

Beijing Cancer hospital — Beijing
Fujian Cancer Hospital — Fuzhou
Local Institution - 0232 — Guangzhou
The Sixth Affiliated Hospital of Sun Yat-sen University — Guangzhou
Guangxi Medical University Affiliated Tumor Hospital — Nanning
Local Institution - 0237 — Harbin
Local Institution - 0282 — Weihui
Local Institution - 0249 — Zhengzhou
… and 14 more centers

Japan · 15 centers