The purpose of this study is to evaluate the safety, tolerability, and efficacy of Pumitamig alone or in combination with other agents in participants with advanced Renal Cell Carcinoma (RCC)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
474
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Number of participants with adverse events (AEs)
Phase 1
Time frame: Up to approximately 2 years from end of treatment
Number of participants with serious adverse events (SAEs) (as per Common Terminology Criteria for Adverse Events v5 (CTCAE v5))
Phase 1
Time frame: Up to approximately 2 years from end of treatment
Number of participants with AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria
Phase 1
Time frame: Up to day 21 from first dose
Number of participants with AEs leading to discontinuation
Phase 1
Time frame: Up to approximately 2 years from end of treatment
Number of participants with AEs leading to death
Phase 1
Time frame: Up to approximately 2 years from end of treatment
Objective response rate (ORR) (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 approximately 2 years from end of treatment
Number of participants with AEs
Phase 2
Time frame: Up to approximately 2 years from end of treatment
Number of participants with SAEs (as per CTCAE v5)
Phase 2
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Specified dose on specified days
Local Institution - 0178
Palo Alto, California, United States
NOT_YET_RECRUITINGLocal Institution - 0117
New Haven, Connecticut, United States
NOT_YET_RECRUITINGSibley Memorial Hospital
Washington D.C., District of Columbia, United States
RECRUITINGLocal Institution - 0177
Miami, Florida, United States
NOT_YET_RECRUITINGLocal Institution - 0126
Orlando, Florida, United States
NOT_YET_RECRUITINGLocal Institution - 0170
Fort Wayne, Indiana, United States
NOT_YET_RECRUITINGUniversity Of Iowa Hospitals And Clinics
Iowa City, Iowa, United States
RECRUITINGJohns Hopkins Hospital
Baltimore, Maryland, United States
RECRUITINGLocal Institution - 0176
Big Rapids, Michigan, United States
NOT_YET_RECRUITINGWashington University School of Medicine
St Louis, Missouri, United States
RECRUITING...and 85 more locations
Time frame: Up to approximately 2 years from end of treatment
Number of participants with treatment-related adverse events (TRAEs)
Phase 2
Time frame: Up to approximately 2 years from end of treatment
Number of participants with AEs leading to discontinuation
Phase 2
Time frame: Up to approximately 2 years from end of treatment
Number of participants with AEs leading to death
Phase 2
Time frame: Up to approximately 2 years from end of treatment
Progression-free survival (PFS) by RECIST v1.1 per investigator assessment
Phase 2
Time frame: Up to 4 years from randomization
Duration of response (DOR) (PR or CR) by RECIST v1.1 per investigator assessment
Phase 2
Time frame: Up to approximately 2 years from end of treatment