Phase 2 Study of Pembrolizumab in Combination With Gemcitabine and Cisplatin as Neoadjuvant Therapy

Phase 2 Completed 39 enrolled UNC Lineberger Comprehensive Cancer Center Merck Sharp & Dohme LLC · collab

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate whether adding pembrolizumab (Keytruda) to the combination of gemcitabine and cisplatin will improve shrinkage of the tumor before having a cystectomy, for people with muscle-invasive bladder cancer (MIBC).

Timeline

Start: 2016-05
Primary completion: 2020-07-06
Completion: 2026-01-30

Outcome

Met primary endpoint

paper Neoadjuvant gemcitabine and cisplatin plus pembrolizumab met its primary end point for improved pathologic downstaging and was generally safe. PMID 34428076 ↗

Publications

Rose TL, Harrison MR, Deal AM, Ramalingam S, Whang YE, Brower B, Dunn M, Osterman CK, Heiling HM, Bjurlin MA, Smith AB, Nielsen ME, Tan HJ, Wallen E, Woods ME, George D, Zhang T, Drier A, Kim WY, Milowsky MI. Phase II Study of Gemcitabine and Split-Dose Cisplatin Plus Pembrolizumab as Neoadjuvant Therapy Before Radical Cystectomy in Patients With Muscle-Invasive Bladder Cancer. J Clin Oncol. 2021 Oct 1;39(28):3140-3148. doi: 10.1200/JCO.21.01003. Epub 2021 Aug 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cisplatin	Other / unclassified	35 mg/m2	—
Subject	Cisplatin	Other / unclassified	70 mg/m2	—
Subject	Gemcitabine	Small molecule	1000 mg/m2	—
Subject	Pembrolizumab	Monoclonal antibody	200 mg	Intravenous