NCT03294304 is a Phase 2 clinical trial of Nivolumab in Muscle Invasive Bladder Cancer, sponsored by Masonic Cancer Center, University of Minnesota.

Who is sponsoring NCT03294304?

NCT03294304 is sponsored by Masonic Cancer Center, University of Minnesota.

What drugs are being tested in NCT03294304?

Interventions in NCT03294304: Nivolumab, Cisplatin, Gemcitabine.

What condition does NCT03294304 study?

NCT03294304 studies Muscle Invasive Bladder Cancer.

Is NCT03294304 still recruiting?

NCT03294304 is currently completed. Last updated 16 December 2021.

Are results published for NCT03294304?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-12-16 · How we verify

NCT03294304

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

BLASST-1 (Bladder Cancer Signal Seeking Trial): Nivolumab, Gemcitabine, and Cisplatin in Treatment of Muscle Invasive Bladder Cancer (MIBC) Undergoing Cystectomy

Completed Phase 2 Results posted Last updated 16 December 2021

What this trial tests

Phase 2 trial testing Nivolumab in Muscle Invasive Bladder Cancer in 43 participants. Completed in 1 July 2021.

Timeline

29 January 2018

Primary endpoint
5 June 2020

1 July 2021

Quick facts

Lead sponsor	Masonic Cancer Center, University of Minnesota
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	43
Start date	29 January 2018
Primary completion	5 June 2020
Estimated completion	1 July 2021
Sites	3 locations across United States

Drugs / interventions tested

Nivolumab (nivolumab) — full drug profile →
Cisplatin (cisplatin) — full drug profile →
Gemcitabine (gemcitabine) — full drug profile →

Conditions studied

Muscle Invasive Bladder Cancer — all drugs for Muscle Invasive Bladder Cancer →

Sponsor

Masonic Cancer Center, University of Minnesota

Who can join

18 and older, any sex, with Muscle Invasive Bladder Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Pathologic Response Rate (PaR) at Time of Radical Cystectomy. PaR is Defined as Absence of Residual MIBC at Cystectomy in the Surgical Specimen (Pathologic Down-staging to ≤pT1pN0 Which Includes pT0, pT1, pTa and pTis) Primary · Surgery Day 1

Incidence of Measurable Disease "pT" in the TNM staging system refers to the size and extend of the primary tumor. The higher the number after the T, the larger the tumor or the more it has grown into nearby tissues. T's may be further divided to provide more detail, such as T3a and T3b. pTa refers to noninvasive papillary carcinoma. pTis refers to carcinoma in situ (CIS) or a "flat tumor" stage. pN refers to lymph nodes. N0 mans cancer has not spread to nearby lymph nodes.

Group	Value	95% CI
Nivolumab, Cisplatin, & Gemcitabine	27

Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 1) Secondary · Treatment Day 1 of cycle 1