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: Open
Phase: III
Principal Investigator: Krishnan, Mridula
Eligibility: https://clinicaltrials.gov/study/NCT07221253?term=NCT07221253&viewType=Card&rank=1#participation-criteria
Summary
Primary Objective:
-To demonstrate the efficacy of rilvegostomig plus chemotherapy relative to durvalumab plus chemotherapy by assessment of OS in the PD-L1 ≥ 1% population.
Secondary Objectives:
-To demonstrate the efficacy of rilvegostomig plus chemotherapy relative to durvalumab plus chemotherapy by assessment of OS in the ITT population.
-To demonstrate the efficacy of rilvegostomig plus chemotherapy relative to durvalumab plus chemotherapy by assessment of PFS in the PD-L1 ≥ 1% population.
-To demonstrate the efficacy of rilvegostomig plus chemotherapy relative to durvalumab plus chemotherapy by assessment of PFS in the ITT population.
-To characterize and compare the efficacy of rilvegostomig plus chemotherapy relative to durvalumab plus chemotherapy by assessment of ORR in the PD-L1 ≥ 1% population.
-To characterize and compare the efficacy of rilvegostomig plus chemotherapy relative to durvalumab plus chemotherapy by assessment of ORR in the ITT population.
-To characterize and compare the efficacy of rilvegostomig plus chemotherapy relative to durvalumab plus chemotherapy by assessment of DoR in the PD-L1 ≥ 1% population.
-To characterize and compare the efficacy of rilvegostomig plus chemotherapy relative to durvalumab plus chemotherapy by assessment of DoR in the ITT population.
-To compare the efficacy of rilvegostomig plus chemotherapy relative to durvalumab plus chemotherapy by assessment of PFS2 in the PD-L1 ≥ 1% population.
-To compare the efficacy of rilvegostomig plus chemotherapy relative to durvalumab plus chemotherapy by assessment of PFS2 in the ITT population.
-To assess the safety and tolerability of rilvegostomig plus chemotherapy compared to durvalumab plus chemotherapy.
-To assess the PK of rilvegostomig.
-To investigate the immunogenicity of rilvegostomig.
-To assess patient-reported BTC symptoms.
-To assess patient-reported GHS/QoL.
Exploratory Objectives:
-To collect and assess blood and tumor samples for biomarker analysis in participants treated with rilvegostomig plus chemotherapy compared to durvalumab plus chemotherapy.
-To assess patient-reported BTC symptoms.
-To describe patient-reported treatment-related symptoms and tolerability.
-To assess patient-reported physical functioning. -To assess patient-reported functioning.
-To assess the impact of treatment and disease on health state in participants.
-To explore the impact of treatment and disease on health care resource use in all randomized participants.
-To describe prevalence, severity, impact, and prophylactic or palliative treatment of patient-reported gastrointestinal symptoms.
-To explore how multi-omics variations, including genetics, may affect clinical parameters, risk and prognosis of diseases and the response to medications as detailed in Appendix D Optional Genomics Initiative.
Note: The samples are taken from consented participants for DNA isolation, blood derivatives, and storage. Results will not be reported in the CSR.