A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy

Summary

The purpose of this study is to evaluate the overall complete response (CR) rate in participants treated with TAR-200 in combination with cetrelimab (Cohort 1), or TAR-200 alone (Cohort 2), or cetrelimab alone (Cohort 3) with Carcinoma in Situ (CIS), with or without concomitant high-grade Ta or T1 papillary disease; and disease-free survival (DFS) in participants treated with TAR-200 alone with papillary disease only (Cohort 4).

Timeline

Start

2020-12-18

Primary completion

2025-07-03

Completion

2027-09-30

Publications

• Daneshmand S, Van der Heijden MS, Jacob JM, Guerrero-Ramos F, Bogemann M, Simone G, Pieczonka CM, Casco NC, Zainfeld D, Spiegelhalder P, Xylinas E, Cahn D, Lotan Y, Murray KS, Kawahara T, Stromberg K, Martin J, Shukla A, Cutie CJ, Bertzos K, Hampras S, Sweiti H, Necchi A; SunRISe-1 Study. TAR-200 for Bacillus Calmette-Guerin-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer: Results From the Phase IIb SunRISe-1 Study. J Clin Oncol. 2025 Nov 20;43(33):3578-3588. doi: 10.1200/JCO-25-01651. Epub 2025 Jul 30.

Drugs

Indications