RECRUITINGPhase 2 / Phase 3INTERVENTIONAL
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)
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
About This Trial
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
Who May Be Eligible (Plain English)
Inclusion Criteria
- Participants must be previously untreated with systemic treatment for advanced/metastatic disease, diagnosed by tissue sample (biopsy-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.
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 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
* 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 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.
Treatments Being Tested
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
Locations (20)
Local Institution - 0284
Phoenix, Arizona, United States
Local Institution - 0437
Los Angeles, California, United States
Local Institution - 0277
Orange, California, United States
Local Institution - 0428
San Francisco, California, United States
Florida Cancer Specialists - South
Fort Myers, Florida, United States
Local Institution - 0433
Jacksonville, Florida, United States
Florida Cancer Specialists - North
St. Petersburg, Florida, United States
Local Institution - 0246
Tampa, Florida, United States
Local Institution - 0377
Atlanta, Georgia, United States
Local Institution - 0379
Chicago, Illinois, United States
Local Institution - 0268
Iowa City, Iowa, United States
Local Institution - 0259
Rochester, Minnesota, United States
Missouri Cancer Associates
Columbia, Missouri, United States
Local Institution - 0286
Omaha, Nebraska, United States
Northwell Health/ RJ Zuckerberg Cancer Center
Lake Success, New York, United States
Local Institution - 0242
New York, New York, United States
Local Institution - 0274
Rochester, New York, United States
Local Institution - 0245
Chapel Hill, North Carolina, United States
Local Institution - 0222
Cleveland, Ohio, United States
Oncology Associates Of Oregon, Pc
Eugene, Oregon, United States