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IBCN 2019: The BLASST-1 Phase II Trial, the Efficacy and Safety of Nivolumab with Gemcitabine-Cisplatin - A Neoadjuvant Option for Patients with MIBC

Aarhus, Denmark (UroToday.com) In this oral abstract session, Dr. Shilpa Gupta from the Cleveland Clinic Taussig Cancer Institute presented data on behalf of the Bladder Cancer Signal Seeking Trial (BLASST-1) group. The BLASST-1 trial is a phase II trial investigating the efficacy and safety of nivolumab with gemcitabine-cisplatin (GC) as a neoadjuvant option for patients with muscle-invasive bladder cancer (NCT03294304).


Eligible patients included those with cT2-T4a, N<=1, M0 MIBC who were cystectomy-eligible. Patients received GC and nivolumab for 4 cycles followed by radical cystectomy within 8 weeks. The primary endpoint was a pathologic response (defined as <=pT1, N0). A total of 41 patients were enrolled; interim analyses were performed when 29 patients underwent RC. The pathologic response was observed in 24 out of 29 patients (82.7%), with no reported deaths from treatment. Adverse events included grade 3-4 neutropenia, thrombocytopenia, and renal insufficiency. There were no surgical complications reported related to therapy, and no delay in time to radical cystectomy (RC).

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Abstract take-home message:

  • Neoadjuvant nivolumab with gemcitabine-cisplatin for cT2-T4a, N<=1, M0 MIBC was associated with an 83% pathologic response rate (defined as p<=T1) (preliminary/interim)

Presented by: Shilpa Gupta, MD, Department of Hematology and Medical Oncology, Cleveland Clinic Taussig Cancer Institute, Cleveland, Ohio