A Phase 2 clinical study to assess efficacy of Induction ipilimumab/nivolumab to spare the Bladder in urothelial bladder cancer (Indi-Blade)

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-512211-41-00

Acronym

M21IDB

Enrollment

Registered

2024-10-10

Start date

2022-01-26

Completion date

Unknown

Last updated

2024-10-10

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

Conditions

Urothelial carcinoma of the bladder and bladder cancer

Brief summary

efficacy defined as bladder-intact event-free survival (BI-EFS). Events consist of death by any cause; muscle-invasive recurrence in the bladder or in the ureter, distal of the crossing with the common iliac artery, nodal or distant recurrence, cystectomy, or switch to cisplatin-based chemotherapy.

Detailed description

Overall survival (OS), recurrence-free survival (RFS), feasibility to proceed to CRT, safety, predictive value of ctDNA, QoL, and bladder function

Interventions

DRUGNIVOLUMAB

DRUGIPILIMUMAB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
efficacy defined as bladder-intact event-free survival (BI-EFS). Events consist of death by any cause; muscle-invasive recurrence in the bladder or in the ureter, distal of the crossing with the common iliac artery, nodal or distant recurrence, cystectomy, or switch to cisplatin-based chemotherapy.	—

Secondary

Measure	Time frame
Overall survival (OS), recurrence-free survival (RFS), feasibility to proceed to CRT, safety, predictive value of ctDNA, QoL, and bladder function	—

Countries

Netherlands

Outcome results

None listed

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