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
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
Arms & interventions
- DrugPumitamig
Specified dose on specified days
- DrugFolfox
Specified dose on specified days
- DrugCapox
Specified dose on specified days
- DrugNivolumab
Specified dose on specified days
Outcome measures
Primary
Objective Response (OR) (confirmed complete response (CR) or partial response (PR)) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment
Phase 2
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)
Phase 3
Time frame: Up to approximately 33 months
Overall survival (OS)
Phase 3
Time frame: Up to approximately 47 months
Secondary
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
Study locations (34)
Local Institution - 0284
Phoenix, Arizona, 85054
Local Institution - 0437
Los Angeles, California, 90033
University of California, Irvine (UCI) Health - UC Irvine Medical Center
Orange, California, 92868
Local Institution - 0428
San Francisco, California, 94158
Florida Cancer Specialists - South
Fort Myers, Florida, 33901
Local Institution - 0433
Jacksonville, Florida, 32224
Florida Cancer Specialists - North
St. Petersburg, Florida, 33701
Local Institution - 0246
Tampa, Florida, 33612
Local Institution - 0377
Atlanta, Georgia, 30308
Local Institution - 0379
Chicago, Illinois, 60637
Local Institution - 0268
Iowa City, Iowa, 52242
Local Institution - 0259
Rochester, Minnesota, 55905
Missouri Cancer Associates
Columbia, Missouri, 65201
Local Institution - 0286
Omaha, Nebraska, 68198
Northwell Health/ RJ Zuckerberg Cancer Center
Lake Success, New York, 11042
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Local Institution - 0274
Rochester, New York, 14642
Local Institution - 0245
Chapel Hill, North Carolina, 27599
Local Institution - 0443
Cleveland, Ohio, 44106
Local Institution - 0222
Cleveland, Ohio, 44195
Oncology Associates Of Oregon, Pc
Eugene, Oregon, 97401
Northwest Cancer Specialists, P.C.
Portland, Oregon, 97213-2982
Local Institution - 0407
Pittsburgh, Pennsylvania, 15213
Local Institution - 0255
Nashville, Tennessee, 37203
SCRI Oncology Partners
Nashville, Tennessee, 37203
Texas Oncology - Amarillo Cancer Center
Amarillo, Texas, 79124
Texas Oncology-Austin Central
Austin, Texas, 78731
Texas Oncology
Beaumont, Texas, 77702
Texas Oncology - Northeast Texas
Denison, Texas, 75020
Texas Oncology - DFW
Grapevine, Texas, 76051
Local Institution - 0233
Houston, Texas, 77030
Texas Oncology - San Antonio
San Antonio, Texas, 78240
Oncology and Hematology Associates of Southwest Virginia, Inc. - Salem
Salem, Virginia, 24153
Local Institution - 0271
Madison, Wisconsin, 53792