Cabozantinib plus Durvalumab in patients with advanced and chemotherapy-treated bladder carcinoma, of urothelial and non-urothelial histology: an open-label, single-centre, phase 2, single-arm proof-of-concept trial: ARCADIA study

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509821-29-00

Enrollment

122

Registered

2024-02-23

Start date

2019-09-25

Completion date

Unknown

Last updated

2025-11-18

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

Conditions

bladder carcinoma of urothelial and non-urothelial histology

Brief summary

The primary endpoint of the study will be overall survival (OS).

Detailed description

To assess OS in patients with bone metastases only., To assess OS in patients with pure non-urothelial histology., Assessment of RR (investigator-assessed) according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. RR (%) = complete (CR) + partial responses (PR)., Assessment of RR according to the immune-related RECIST criteria., FDG-PET response in bone metastases (EORTC criteria)., Response duration (including stable diseases [SD])., Progression-Free Survival (investigator-assessed)., Correlative biological/immunologic endpoints.

Interventions

DRUGCABOMETYX 20 mg film-coated tablets

DRUGCABOMETYX 40 mg film-coated tablets

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
The primary endpoint of the study will be overall survival (OS).	—

Secondary

Measure	Time frame
To assess OS in patients with bone metastases only., To assess OS in patients with pure non-urothelial histology., Assessment of RR (investigator-assessed) according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. RR (%) = complete (CR) + partial responses (PR)., Assessment of RR according to the immune-related RECIST criteria., FDG-PET response in bone metastases (EORTC criteria)., Response duration (including stable diseases [SD])., Progression-Free Survival (investigator-assessed)., Correlative biological/immunologic endpoints.	—

Measure

Time frame

—

Countries

Italy

Outcome results

None listed

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