drugset / Trial / NCT04123470
A Phase I/II Trial Investigating LOAd703 in Combination With Atezolizumab in Malignant Melanoma
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
Publications
- Grauers Wiktorin H, Ekstrom-Ryden V, Ek I, Eriksson E, Lovgren T, Bernedal Nordstrom C, Sandin LC, Patel MR, Hamid O, Ullenhag G, Loskog A. Reprogramming myeloid cells and restoring T cell fitness in checkpoint inhibitor resistant melanoma patients. Biomark Res. 2026 Mar 27;14(1):38. doi: 10.1186/s40364-026-00917-z.
- Hamid O, Ekstrom-Ryden V, Mehmi I, Wang D, Patel M, Alsaqal S, Irenaeus S, Nordstrom C, Sandin LC, Grauers Wiktorin H, Lovgren T, Eriksson E, Leja-Jarblad J, Loskog A, Ullenhag GJ. LOAd703-induced tumor microenvironment gene engineering in combination with atezolizumab in metastatic malignant melanoma: a phase I/II trial. Nat Commun. 2026 Feb 16;17(1):1760. doi: 10.1038/s41467-026-69629-0.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atezolizumab | Monoclonal antibody | 1200 mg | Intravenous |
| Subject | delolimogene mupadenorepvec | Unknown | 1e+11 unknown | Other |
| Subject | delolimogene mupadenorepvec | Unknown | 5e+11 unknown | Other |