drugset / Trial / NCT03735290

A Study to Evaluate the Safety and Effectiveness of ILIxadencel Administered Into Tumors in Combination With Checkpoint Inhibitor (CPI) in Patients With ADvanced Cancer

NCT03735290 ↗

Phase 1 Terminated 21 enrolled Mendus PPD Development, LP · collab
RandomizedSequentialOpen-labelTreatment

Summary

Patients in the Phase 1b part of the study will be treated with ilixadencel at an increasing dose and frequency, in combination with standard doses and schedules of checkpoint inhibitor (CPI) pembrolizumab. The Phase 1b study will determine the optimal dose and schedule of ilixadencel. Patients in the Phase 2 part of the study will be randomly assigned to receive either ilixadencel (at the dose determined in Phase 1b) combined with the CPI, or only the CPI. Note: Recruitment to Phase 1b of the study has been completed.

Timeline

Start
2019-01-14
Primary completion
2021-12-03
Completion
2021-12-03

Outcome

Outcome not reported

Stopped: “Decision made not to move to Phase 2”

Drugs

EvaluationDrugModalityDoseRoute
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous
Subject ilixadencel Cell therapy 3e+06 cells Other
Subject ilixadencel Cell therapy 1e+07 cells Other