Trial results for intermittent checkpoint inhibitor therapy, including atezolizumab, in patients with advanced urothelial carcinoma were posted on 2025-02-25. The study, NCT04322643, reported a median treatment-free interval of 94.1 weeks and that 4 participants sustained a response post-suspension of therapy.
Background
Checkpoint inhibitors like atezolizumab are a class of immunotherapies used in various cancers, including advanced urothelial carcinoma. These therapies work by blocking proteins that prevent the immune system from attacking cancer cells. The study aimed to investigate the safety and effectiveness of intermittent checkpoint inhibitor therapy in this patient population, exploring strategies to optimize treatment duration and reduce toxicity.
Trial design
This Phase 2 trial (NCT04322643) was designed to test intermittent checkpoint inhibitor therapy in patients with advanced urothelial carcinoma. The study enrolled 4 participants and included interventions with checkpoint inhibitors such as atezolizumab, pembrolizumab, durvalumab, nivolumab, and avelumab. The trial was terminated.
Key results
Key measurements from the trial included:
- The number of participants that sustained a response post-checkpoint inhibitor suspension was 4 participants.
- The median treatment-free interval (TFI) was 94.1 weeks.
- The overall response rate (ORR) was observed in 4 participants.
- The number of participants with progression-free survival (PFS) was 4 participants.
- The number of participants with overall survival (OS) was 4 participants.
What this means
The results from this small Phase 2 trial suggest that intermittent checkpoint inhibitor therapy, including atezolizumab, may allow for a significant treatment-free interval in patients with advanced urothelial carcinoma. A median treatment-free interval of 94.1 weeks, coupled with 4 participants sustaining a response post-suspension, indicates potential for reducing continuous treatment burden while maintaining clinical benefit. However, given the limited enrollment of 4 participants, these findings are preliminary and warrant further investigation in larger studies.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04322643, titled "Intermittent Checkpoint Inhibitor Therapy In Patients With Advanced Urothelial Carcinoma," were posted on 2025-02-25 on clinicaltrials.gov.