Phase III, Randomized, Open-label, Global, Multicenter Study of Rilvegostomig or Durvalumab in Combination With Chemotherapy as a First-line Treatment for Patients With Advanced Biliary Tract Cancer (ARTEMIDE-Biliary02)
Categories (click each to see list of all clinical trials associated with that category): FPBCC CTO Studies, GI (ONC)
Current Status: Not open
Phase: III
Principal Investigator: Krishnan, Mridula
Contact Information:
Erin Drengler
edrengler@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT07221253?term=NCT07221253&viewType=Card&rank=1#participation-criteria
Summary
Primary Objective: To evaluate the efficacy of zanzalintinib + MK-3475A and zanzalintinib monotherapy compared with placebo as measured by DFS
Secondary Objectives: To evaluate the efficacy of zanzalintinib + MK-3475A and zanzalintinib monotherapy compared with placebo as measured by ctDNA clearance. -To evaluate the efficacy of zanzalintinib + MK-3475A and zanzalintinib monotherapy compared with placebo as measured by OS. - To evaluate the efficacy of zanzalintinib + MK-3475A compared with zanzalintinib
monotherapy as measured by DFS. -To evaluate the safety and tolerability profile of zanzalintinib + MK-3475A and zanzalintinib monotherapy compared with placebo.
Exploratory Objectives: -To characterize the pharmacokinetics of zanzalintinib. -To further evaluate the efficacy of zanzalintinib + MK-3475A and zanzalintinib monotherapy compared with placebo on TTR. -To evaluate baseline and changes in ctDNA levels. -To evaluate the effect of zanzalintinib + MK- 3475A and zanzalintinib monotherapy compared with placebo on HRQOL.