| Title: |
CREST: phase III study of sasanlimab and Bacillus Calmette-Guérin for patients with Bacillus Calmette-Guérin-naïve high-risk non-muscle-invasive bladder cancer. |
| Authors: |
Steinberg, GD; Shore, ND; Redorta, JP; Galsky, MD; Bedke, J; Ku, JH; Kretkowski, M; Hu, H; Penkov, K; Vermette, JJ; Tarazi, JC; Randall, AE; Pierce, KJ; Saltzstein, D; Powles, TB |
| Publisher Information: |
Taylor & Francis Group |
| Publication Year: |
2024 |
| Collection: |
Queen Mary University of London: Queen Mary Research Online (QMRO) |
| Subject Terms: |
BCG; Bacillus Calmette-Guérin; NMIBC; PD-1; PD-L1; bladder cancer; immune checkpoint inhibitor; immunotherapy; non-muscle-invasive bladder cancer; sasanlimab; Humans; Administration; Intravesical; BCG Vaccine; Clinical Trials; Phase III as Topic; Immune Checkpoint Inhibitors; Neoplasm Invasiveness; Neoplasm Recurrence; Local; Non-Muscle Invasive Bladder Neoplasms; Progression-Free Survival; Randomized Controlled Trials as Topic; Urinary Bladder Neoplasms |
| Description: |
Bacillus Calmette-Guérin (BCG) is the standard of care for patients with high-risk non-muscle-invasive bladder cancer (NMIBC) after transurethral resection of bladder tumor (TURBT). BCG in combination with programmed cell death-1 (PD-1) inhibitors may yield greater anti-tumor activity compared with either agent alone. CREST is a phase III study evaluating the efficacy and safety of the subcutaneous PD-1 inhibitor sasanlimab in combination with BCG for patients with BCG-naive high-risk NMIBC. Eligible participants are randomized to receive sasanlimab plus BCG (induction ± maintenance) or BCG alone for up to 25 cycles within 12 weeks of TURBT. The primary outcome is event-free survival. Secondary outcomes include additional efficacy end points and safety. The target sample size is around 1000 participants. |
| Document Type: |
article in journal/newspaper |
| File Description: |
891 - 901 |
| Language: |
English |
| Relation: |
Future Oncology; https://qmro.qmul.ac.uk/xmlui/handle/123456789/100845 |
| DOI: |
10.2217/fon-2023-0271 |
| Availability: |
https://qmro.qmul.ac.uk/xmlui/handle/123456789/100845; https://doi.org/10.2217/fon-2023-0271 |
| Rights: |
This work is licensed under the Attribution-NonCommercial-NoDerivatives 4.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-nd/4.0/ ; © 2024 The Authors |
| Accession Number: |
edsbas.634E0947 |
| Database: |
BASE |