drugset / Trial / NCT04123470

A Phase I/II Trial Investigating LOAd703 in Combination With Atezolizumab in Malignant Melanoma

NCT04123470

Phase 1/2 Completed 24 enrolled Lokon Pharma AB Precision Oncology LLC · collab
NaSequentialOpen-labelTreatment

Summary

This study aims to evaluate safety and effect of combining an oncolytic adenovirus (delolimogene mupadenorepvec; LOAd703) with atezolizumab in patients with melanoma. LOAd703 will be administered intratumorally for up to 12 injections while atezolizumab will be administered intravenously for the duration of the active study visits (up to 57 weeks). The patients are then monitored for survival for maximum study participation of 48 months. The treatments will be given every 3 weeks. The patients will then be monitored for toxicity, PK, ADA, immune responses, virus shedding, tumor response by RECIST 1.1 and survival.

Timeline

Start
2020-01-28
Primary completion
2023-07-30
Completion
2023-07-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Atezolizumab Monoclonal antibody 1200 mg Intravenous
Subject delolimogene mupadenorepvec Unknown 1e+11 unknown Other
Subject delolimogene mupadenorepvec Unknown 5e+11 unknown Other

Indications