drugset / Trial / NCT05200988
Checkpoint Inhibition and Chemoradiotherapy as Bladder Sparing Treatment in UC
Phase 2
Active not recruiting
50 enrolled
The Netherlands Cancer Institute
Bristol-Myers Squibb · collab
NaSingle-groupOpen-labelTreatment
Summary
This is a single-armed, multicenter, non-blinded phase 2 study to assess efficacy of induction ipilimumab + nivolumab followed by chemoradiation to spare the bladder in urothelial bladder cancer.
Timeline
- Start
- 2022-03-14
- Primary completion
- 2025-09-05
- Completion
- 2027-09-05
Publications
- Mellema JJ, Stockem CF, Herberts C, Cheung SK, Vis DJ, van Rhijn BWG, Mertens LS, Boellaard TN, van Montfoort ML, Balduzzi S, de Feijter JM, van der Mijn JCK, Sharma S, El Naggar AC, Boormans JL, Franckena M, Meijer RP, Noteboom JL, Schaake EE, Robbrecht DGJ, Suelmann BBM, van der Heijden MS. Ipilimumab and nivolumab followed by chemoradiotherapy as bladder-sparing treatment in muscle-invasive bladder cancer: a phase 2 trial. Nat Med. 2026 Apr;32(4):1241-1248. doi: 10.1038/s41591-026-04271-3. Epub 2026 Feb 27.
- Stockem CF, Mellema JJJ, van Rhijn BWG, Boellaard TN, van Montfoort ML, Balduzzi S, Boormans JL, Franckena M, Meijer RP, Robbrecht DGJ, Suelmann BBM, Schaake EE, van der Heijden MS. Induction therapy with ipilimumab and nivolumab followed by consolidative chemoradiation as organ-sparing treatment in urothelial bladder cancer: study protocol of the INDIBLADE trial. Front Oncol. 2023 Aug 29;13:1246603. doi: 10.3389/fonc.2023.1246603. eCollection 2023.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ipilimumab | Monoclonal antibody | 3 mg/kg | — |
| Subject | Nivolumab | Monoclonal antibody | 3 mg/kg | — |
| Background | Ipilimumab + nivolumab | Unknown | 500 mg/m2 | Intravenous |
| Background | Mitomycin C | Other / unclassified | 12 mg/m2 | — |
| Background | capecitabin | Unknown | 825 mg/m2 | Oral |