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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
690
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Local Institution - 0284
Phoenix, Arizona, United States
NOT_YET_RECRUITINGLocal Institution - 0437
Los Angeles, California, United States
NOT_YET_RECRUITINGLocal Institution - 0277
Orange, California, United States
NOT_YET_RECRUITINGLocal Institution - 0428
San Francisco, California, United States
NOT_YET_RECRUITINGObjective 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
PFS by RECIST v1.1 per investigator assessment
Phase 2
Time frame: Up to approximately 33 months
Duration of Response (DOR) (CR or PR) by RECIST v1.1 per investigator assessment
Phase 2
Time frame: Up to approximately 33 months
Time to Response (TTR) (CR or PR) by RECIST v1.1 per investigator assessment
Phase 2
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
Phase 2
Time frame: Up to approximately 33 months
Recommended dose of Pumitamig for Phase 3
Phase 2
Time frame: Up to approximately 33 months
Objective response (OR) by RECIST v1.1 per BICR
Phase 3
Time frame: Up to approximately 33 months
DOR by RECIST v1.1 per BICR
Phase 3
Time frame: Up to approximately 33 months
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CONTACT
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Florida Cancer Specialists - South
Fort Myers, Florida, United States
RECRUITINGLocal Institution - 0433
Jacksonville, Florida, United States
NOT_YET_RECRUITINGFlorida Cancer Specialists - North
St. Petersburg, Florida, United States
RECRUITINGLocal Institution - 0246
Tampa, Florida, United States
WITHDRAWNLocal Institution - 0377
Atlanta, Georgia, United States
NOT_YET_RECRUITINGLocal Institution - 0379
Chicago, Illinois, United States
NOT_YET_RECRUITING...and 150 more locations