The purpose of this study is to evaluate the safety and efficacy of pumitamig in combination with chemotherapy versus bevacizumab in combination with chemotherapy in participants with previously untreated, unresectable, or metastatic colorectal cancer
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
990
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Local Institution - 0428
Tucson, Arizona, United States
NOT_YET_RECRUITINGHighlands Oncology Group
Springdale, Arkansas, United States
RECRUITINGUSC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
RECRUITINGLocal Institution - 0330
Los Angeles, California, United States
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 5 years
Progression Free Survival (PFS) by RECIST v1.1 per blinded independent central review (BICR)
Phase 3
Time frame: Up to 5 years
Overall Survival (OS)
Phase 3
Time frame: Up to 5 years
PFS by RECIST v1.1 per investigator assessment
Phase 2
Time frame: Up to 5 years
Duration of Response (DOR) (CR or PR) by RECIST v1.1 per investigator assessment
Phase 2
Time frame: Up to 5 years
Time to Response (TTR) (CR or PR) by RECIST v1.1 per investigator assessment
Phase 2
Time frame: Up to 5 years
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 5 years
Recommended dose of Pumitamig for Phase 3
Phase 2
Time frame: Up to 5 years
OR by RECIST v1.1 per BICR
Phase 3
Time frame: Up to 5 years
DOR by RECIST v1.1 per BICR
Phase 3
Time frame: Up to 5 years
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University of California, Irvine (UCI) Health - UC Irvine Medical Center
Orange, California, United States
RECRUITINGLocal Institution - 0317
San Francisco, California, United States
NOT_YET_RECRUITINGFlorida Cancer Specialists - East
Cape Coral, Florida, United States
RECRUITINGFlorida Cancer Specialists - North
St. Petersburg, Florida, United States
RECRUITINGMoffitt Cancer Center
Tampa, Florida, United States
RECRUITINGLocal Institution - 0326
Atlanta, Georgia, United States
NOT_YET_RECRUITING...and 275 more locations