ROSETTA RCC-208: A Phase 1/2 Open-label, Multi-center, Randomized Study of Pumitamig Alone or in Combination With Ipilimumab or Cabozantinib in Participants With Advanced Renal Cell Carcinoma (RCC)
Summary
The purpose of this study is to evaluate the safety, tolerability, and efficacy of Pumitamig alone or in combination with Ipilimumab or Cabozantinib in participants with advanced Renal Cell Carcinoma (RCC)
Arms & interventions
- DrugPumitamig
Specified dose on specified days
- DrugIpilimumab
Specified dose on specified days
- DrugCabozantinib
Specified dose on specified days
Outcome measures
Primary
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
Secondary
Number of participants with AEs
Time frame: Up to approximately 2 years from end of treatment
Number of participants with SAEs (as per CTCAE v5)
Time frame: Up to approximately 2 years from end of treatment
Number of participants with treatment-related adverse events (TRAEs)
Time frame: Up to approximately 2 years from end of treatment
Number of participants with AEs leading to discontinuation
Time frame: Up to approximately 2 years from end of treatment
Number of participants with AEs leading to death
Time frame: Up to approximately 2 years from end of treatment
Progression-free survival (PFS) by RECIST v1.1 per investigator assessment
Time frame: Up to 4 years from randomization
Duration of response (DOR) (PR or CR) by RECIST v1.1 per investigator assessment
Time frame: Up to approximately 2 years from end of treatment
Eligibility criteria
Study locations (13)
Local Institution - 0117
New Haven, Connecticut, 06510
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016
Local Institution - 0126
Orlando, Florida, 32803
Local Institution - 0124
Iowa City, Iowa, 52242
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Washington University School of Medicine
St Louis, Missouri, 63110
Local Institution - 0096
Hauppauge, New York, 11788
Local Institution - 0135
Cincinnati, Ohio, 45219
Local Institution - 0127
Cleveland, Ohio, 44195
MUSC Hollings Cancer Center
Charleston, South Carolina, 29425
Carolina Urologic Research Center, LLC
Myrtle Beach, South Carolina, 29572
Local Institution - 0158
Salt Lake City, Utah, 84112
Local Institution - 0095
Seattle, Washington, 98109-1023