Posted: Wednesday, November 23, 2022
The JAVELIN Bladder Medley trial was announced at the 2022 Society for Immunotherapy of Cancer (SITC) Annual Meeting (Abstract 665). “We hypothesized that avelumab-based combinations may further improve outcomes in this setting. The JAVELIN Bladder Medley trial will investigate such combinations as [first-line] maintenance therapy for advanced urothelial carcinoma,” said Jean Hoffman-Censits, MD, of the Sidney Kimmel Cancer Center at John Hopkins, Baltimore, and colleagues.
The announcement comes after the JAVELIN Bladder 100 (ClinicalTrials.gov identifier NCT02603432) trial, which combined the anti–PD-L1 agent avelumab and first-line maintenance plus best supportive care. The successes of the initial trial, which included prolonged overall and progression-free survival in patients with advanced urothelial carcinoma, led the authors to predict further improvements may be possible.
The authors reported that the JAVELIN Bladder Medley study (NCT05327530) is a phase II, randomized, multicenter, open-label, parallel-arm, umbrella trial. It will enroll patients with unresectable, advanced, or metastatic urothelial carcinoma that has not progressed after four to six cycles of first-line chemotherapy. The patients will then be randomly assigned to four arms at a ratio of 1:2:2:2. Patients in the control arm will receive avelumab at 800 mg every 2 weeks as monotherapy. Trial arms will include avelumab at 800 mg every 2 weeks in combination with one of the following: sacituzumab govitecan-hziy at 10 mg/kg on days 1 and 8 of 21-day cycles, M6223 (anti-TIGIT) at 1,600 mg every 2 weeks, or NKTR-255 (interleukin-15 agonist) at 3 mg/kg every 4 weeks.
Investigators will assess progression-free survival and safety of the experimental regimens. The group also announced secondary endpoints of overall survival, objective response, and duration of response. Finally, the trial opened in June 2022 and will recruit patients from locations in the United States, Europe, Asia, and Australia.
Disclosure: No disclosure information was provided.