IMMUWHY - A phase II study of immunotherapy with durvalumab (MEDI4736) or durvalumab and tremelimumab, both combined with Y-90 SIRT therapy in patients with advanced stage intrahepatic biliary tract cancer (BTC) scheduled to receive Y-90 SIRT therapy as standard of care

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508314-42-00

Acronym

IMMUWHY

Enrollment

Registered

2023-11-21

Start date

2020-02-27

Completion date

Unknown

Last updated

2026-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced stage intrahepatic biliary tract cancer (BTC)

Brief summary

Objective response rate (ORR) [according to RECIST 1.1]

Detailed description

Safety (rate of adverse events), Duration of response (DoR), Progression free survival (PFS), Overall survival (OS), Exploratory: Predictive biomarkers for ORR, DoR, PFS, OS

Interventions

DRUGIMJUDO 20 mg/ml concentrate for solution for infusion.

DRUGIMFINZI 50 mg/mL concentrate for solution for infusion.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Objective response rate (ORR) [according to RECIST 1.1]	—

Secondary

Measure	Time frame
Safety (rate of adverse events), Duration of response (DoR), Progression free survival (PFS), Overall survival (OS), Exploratory: Predictive biomarkers for ORR, DoR, PFS, OS	—

Countries

Germany, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026