An open-label randomized trial of the efficacy and safety of zanidatamab with standard-of-care therapy against standard of-care therapy alone for advanced HER2 positive biliary tract cancer

Conditions

BTC - Biliary Tract Cancer

Brief summary

Progression-free survival (PFS) per the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) in the immunohistochemistry (IHC) 3+ subgroup

Detailed description

Overall survival (OS) in the IHC 3+ subgroup, PFS per RECIST 1.1 in the overall population, OS in the overall population, Confirmed objective response rate (cORR) per RECIST 1.1, Duration of response (DOR) per RECIST 1.1, Frequency, severity, seriousness, and relatedness of treatment-emergent adverse events (AEs), Serum concentrations of zanidatamab as a function of time post-dosing, Frequency, duration, and time of onset of antizanidatamab antibodies and neutralizing antibodies, if applicable, to zanidatamab, Time to definitive deterioration (TDD) from baseline in the IHC 3+ subgroup in patientreported global health status (GHS) score as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire – Core 30 (QLQC30), TDD from baseline in the overall population in patientreported GHS score as measured by the EORTC QLQC30, Change from baseline in health economics and outcomes research/patient-reported outcome (HEOR/PRO) parameters using the EORTC QLQC30, Quality of Life Questionnaire – Cholangiocarcinoma and Gallbladder Cancer module (QLQ-BIL21), and 5level EuroQol5 Dimension (EQ-5D-5L)

Related papers

No related papers found yet.

Interventions

DRUGCisplatinum Accord

DRUG1 mg/ml

DRUGkoncentrat do sporządzania roztworu do infuzji.

DRUGIMFINZI 50 mg/mL concentrate for solution for infusion.

DRUGGemcitabin Hikma 38 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGJZP598

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression-free survival (PFS) per the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) in the immunohistochemistry (IHC) 3+ subgroup	—

Secondary

Measure	Time frame
Overall survival (OS) in the IHC 3+ subgroup, PFS per RECIST 1.1 in the overall population, OS in the overall population, Confirmed objective response rate (cORR) per RECIST 1.1, Duration of response (DOR) per RECIST 1.1, Frequency, severity, seriousness, and relatedness of treatment-emergent adverse events (AEs), Serum concentrations of zanidatamab as a function of time post-dosing, Frequency, duration, and time of onset of antizanidatamab antibodies and neutralizing antibodies, if applicable, to zanidatamab, Time to definitive deterioration (TDD) from baseline in the IHC 3+ subgroup in patientreported global health status (GHS) score as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire – Core 30 (QLQC30), TDD from baseline in the overall population in patientreported GHS score as measured by the EORTC QLQC30, Change from baseline in health economics and outcomes research/patient-reported outcome (HEOR/PRO) parameters usin	—

Measure

Time frame

Overall survival (OS) in the IHC 3+ subgroup, PFS per RECIST 1.1 in the overall population, OS in the overall population, Confirmed objective response rate (cORR) per RECIST 1.1, Duration of response (DOR) per RECIST 1.1, Frequency, severity, seriousness, and relatedness of treatment-emergent adverse events (AEs), Serum concentrations of zanidatamab as a function of time post-dosing, Frequency, duration, and time of onset of antizanidatamab antibodies and neutralizing antibodies, if applicable, to zanidatamab, Time to definitive deterioration (TDD) from baseline in the IHC 3+ subgroup in patientreported global health status (GHS) score as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire – Core 30 (QLQC30), TDD from baseline in the overall population in patientreported GHS score as measured by the EORTC QLQC30, Change from baseline in health economics and outcomes research/patient-reported outcome (HEOR/PRO) parameters usin

—

Countries

Belgium, Czechia, Finland, France, Germany, Italy, Portugal, Romania, Spain, Sweden

Outcome results

None listed