The primary objective of this study is to compare the efficacy of tarlatamab with placebo as assessed by progression free survival (PFS) based on blinded independent central review (BCIR) per response evaluation criteria in solid tumors v1.1 (RECIST 1.1) and on prolonging overall survival (OS).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
400
Intravenous (IV) infusion
IV infusion
PFS as Determined by BICR
Time frame: Up to approximately 6 years
OS Over the Whole Trial
Time frame: Up to approximately 6 years
PFS Determined by Investigator Assessment
Time frame: Up to approximately 6 years
Complete Response (CR) Rate
Time frame: Up to approximately 6 years
CR + non-CR/non-Progressive Disease (PD) Rate
Time frame: Up to approximately 6 years
Duration of Complete Response
Time frame: Up to approximately 6 years
PFS at 6 months, 1 year, 2 years
Time frame: 6 months, 1 year, 2 years
OS at 6 months, 1 year, 2 years, 3 years
Time frame: 6 months, 1 year, 2 years, 3 years
Time to Progression (TTP)
Time frame: Up to approximately 6 years
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to approximately 6 years
Serum Concentration of Tarlatamab
Time frame: Up to approximately 4 months
Incidence of Anti-tarlatamab Antibody Formation
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Valkyrie Clinical Trials
Los Angeles, California, United States
RECRUITINGUniversity of California Los Angeles
Santa Monica, California, United States
RECRUITINGYale New Haven Hospital
New Haven, Connecticut, United States
RECRUITINGBoca Raton Clinical Research Global South Florida
Plantation, Florida, United States
RECRUITINGUniversity of Louisville James Graham Brown Cancer Center
Louisville, Kentucky, United States
RECRUITINGOur Lady of the Lake Cancer Institute
Baton Rouge, Louisiana, United States
RECRUITINGMorristown Medical Center
Morristown, New Jersey, United States
TERMINATEDNew York University Grossman School of Medicine and New York University Langone Hospitals
New York, New York, United States
COMPLETEDPerlmutter Cancer Center at New York University Langone Hospital - Long Island
New York, New York, United States
COMPLETEDMontefiore Einstein Center for Cancer Care
The Bronx, New York, United States
TERMINATED...and 194 more locations
Time frame: Up to approximately 1 year