A phase 1b-2 study of mitomycin-C / capecitabine chemoradiotherapy combined with ipilumimab and nivolumab or nivolumab monotherapy as bladder sparing curative treatment for muscle invasive bladder cancer: the CRIMI study

Status

Not yet recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509460-19-00

Enrollment

Registered

2024-10-11

Start date

Unknown

Completion date

Unknown

Last updated

2024-10-11

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

Conditions

Muscle Invasive bladder cancer

Brief summary

In the phase Ib study: toxicity scored with CTCAE v 4.03; incidence of dose limiting toxicity (DLT) during the first 6 weeks after start of the combination, In the phase II study: disease free survival (DFS) and disease free survival-rate (DFS-rate)

Detailed description

Overall Survival, Overall survival-rate, Response rate according to RECIST 1.1, Toxicity according to CTCAE v4.03

Interventions

DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.

DRUGYERVOY 5 mg/ml concentrate for solution for infusion

DRUGMitomycine Accord 40 mg

DRUGpoeder voor oplossing voor injectie/infusie

DRUGCapecitabine Teva 150 mg film-coated tablets.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
In the phase Ib study: toxicity scored with CTCAE v 4.03; incidence of dose limiting toxicity (DLT) during the first 6 weeks after start of the combination, In the phase II study: disease free survival (DFS) and disease free survival-rate (DFS-rate)	—

Secondary

Measure	Time frame
Overall Survival, Overall survival-rate, Response rate according to RECIST 1.1, Toxicity according to CTCAE v4.03	—

Countries

Netherlands

Outcome results

None listed

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