Gemcitabine and cisplatin plus nivolumab as organ-sparing treatment for muscle-invasive bladder cancer: a phase 2 trial
Nature Medicine, 2023
Galsky M., Daneshmand S., Izadmehr S., Gonzalez-Kozlova E., Chan K., Lewis S., Achkar B., Dorff T., Cetnar J., Neil B., D’Souza A., Mamtani R., Kyriakopoulos C., Jun T., Gogerly-Moragoda M., Brody R., Xie H., Nie K., Kelly G., Horowitz A., Kinoshita Y., Ellis E., Nose Y., Ioannou G., Cabal R., Del Valle D., Haines G., Wang L., Mouw K., Samstein R., Mehrazin R., Bhardwaj N., Yu M., Zhao Q., Kim-Schulze S., Sebra R., Zhu J., Gnjatic S., Sfakianos J., Pal S.
| Disease area | Application area | Sample type | Products |
|---|---|---|---|
Oncology | Pathophysiology | Plasma Urine |  Olink Target 96 |
Abstract
Cystectomy is a standard treatment for muscle-invasive bladder cancer (MIBC), but it is life-altering. We initiated a phase 2 study in which patients with MIBC received four cycles of gemcitabine, cisplatin, plus nivolumab followed by clinical restaging. Patients achieving a clinical complete response (cCR) could proceed without cystectomy. The co-primary objectives were to assess the cCR rate and the positive predictive value of cCR for a composite outcome: 2-year metastasis-free survival in patients forgoing immediate cystectomy or