The purpose of this study is to assess the objective response rate (ORR) of immunotherapy-based combination therapy and to assess the safety and tolerability of immunotherapy-based combination therapy.
The study includes multiple substudy arms (Substudy A, B, C), which will evaluate immunotherapy-based combinations.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
400
Administered as specified in the treatment arm
Administered as specified in the treatment arm
Administered as specified in the treatment arm
Objective response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Time frame: Up to 58 months
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Time frame: Up to 58 months
Overall Survival (OS)
Time frame: From date of first dose until the date of death due to any cause (approximately 58 months)
Progression-free Survival (PFS) as determined by the Investigator according to RECIST v1.1
Time frame: Up to 58 months
Disease Control Rate (DCR)
Time frame: Up to 58 months
Duration of response (DoR) as determined by the Investigator according to RECIST v1.1
Time frame: Up to 58 months
Investigational study treatments peak plasma or serum concentration (Cmax)
Time frame: Up to 58 months
Investigational study treatments time of peak concentration (Tmax)
Time frame: Up to 58 months
Investigational study treatments area under the plasma or serum concentration versus time curve (AUC)
Time frame: Up to 58 months
Percentage of biologic treatment-emergent antidrug-antibody (ADA)-positive participants and ADA-negative participants
Time frame: Up to 58 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Administered as specified in the treatment arm
Administered as specified in the treatment arm
University of Alabama at Birmingham (UAB)
Birmingham, Alabama, United States
University of California San Diego (UCSD)
La Jolla, California, United States
Memorial Cancer Institute at Memorial Regional Hospital
Hollywood, Florida, United States
Hematology Oncology Associates Of The Treasure Coast
Port Saint Lucie, Florida, United States
Florida Cancer Specialists (Administration and Drug Shipment)
The Villages, Florida, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Ochsner Clinic Foundation
Jefferson, Louisiana, United States
Henry Ford Hospital
Detroit, Michigan, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
Medical Oncology Associated, PS (dba Summit Cancer Centers)
Spokane, Washington, United States
...and 43 more locations