Phase III Study of Rilvegostomig plus Combination Chemotherapy versus Durvalumab plus Combination Chemotherapy in Patients with Advanced Biliary Tract Cancer

The primary objective of this study is to evaluate the efficacy of rilvegostomig combined with chemotherapy compared to durvalumab plus chemotherapy in patients with advanced biliary tract cancer, specifically assessing overall survival (OS) within the population expressing PD-L1 ≥ 1%. Secondary objectives include the assessment of OS in the intention-to-treat (ITT) population, as well as the evaluation of progression-free survival (PFS) in both the PD-L1 ≥ 1% and ITT populations.

This study involves 868 participants diagnosed with biliary tract cancer. The population consists of both male and female patients within specific age ranges. Eligible individuals must have histologically confirmed adenocarcinoma, including intra-hepatic or extra-hepatic cholangiocarcinoma or gallbladder carcinoma. Inclusion requires the presence of unresectable locally advanced or metastatic disease that is previously untreated in the advanced setting. Participants must have a known PD-L1 status and measurable disease according to RECIST 1.1 criteria via CT or MRI. Furthermore, subjects are required to have an ECOG Performance Status of 0 or 1 and demonstrate adequate bone marrow and organ function.

This Phase III, randomized, open-label, global, multicenter study evaluates the efficacy and safety of rilvegostomig in combination with chemotherapy compared to durvalumab plus chemotherapy as a first-line treatment for patients with advanced biliary tract cancer. The primary objective is to assess overall survival in the population with PD-L1 expression $\geq$ 1%. The secondary endpoint includes progression-free survival. Eligible participants must have histologically confirmed adenocarcinoma of the biliary tract, including cholangiocarcinoma or gallbladder carcinoma, that is unresectable, locally advanced, or metastatic and previously untreated. Inclusion requires measurable disease according to RECIST 1.1 criteria, an ECOG Performance Status of 0 or 1, and adequate bone marrow and organ function. The study involves a screening visit to assess eligibility, followed by treatment and subsequent monitoring until the end-of-study assessment. The estimated trial duration spans from December 2025 to July 2029.

Rilvegostomig is administered as a solution for infusion via intravenous use at a dose of 0 mg.

The comparator treatment consists of cisplatin, administered via intravenous use at a dose of 0 mg/ml, and gemcitabine, administered via intravenous use at a dose of 0 mg/ml. Additionally, durvalumab, provided as Imfinzi 50 mg/mL concentrate for solution for infusion, is administered via intravenous use at a dose of 0 mg/ml.

Auxiliary medications include mycophenolate mofetil, administered via oral use at a dose of 0 mg, and infliximab, administered via intravenous use at a dose of 0 mg.

The primary efficacy endpoint for this study is overall survival, comparing the administration of rilvegostomig plus chemotherapy to durvalumab plus chemotherapy. The evaluation is specifically focused on the population with PD-L1 expression of ≥ 1% in patients with biliary tract cancer.

The secondary endpoint includes the assessment of progression-free survival for the rilvegostomig plus chemotherapy group relative to the durvalumab plus chemotherapy group.