NCT04123470

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Lokon Pharma AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a single arm, open-label, multicenter trial. This study aims to evaluate safety and effect of combining an oncolytic adenovirus (delolimogene mupadenorepvec; LOAd703) with atezolizumab in patients with melanoma. Patients will receive up to 12 LOAd703 intratumoral treatments in combination with intravenous infusions of atezolizumab. LOAd703 will be tested at two dose levels to determine the maximum tolerated dose (MTD) of LOAd703 evaluated in the study using a BOIN design. The LOAd703 dose can be divided for intratumoral injection into as many as 3 tumor lesions. Atezolizumab will be tested at a fixed dose. At least 25 response evaluable patients will be enrolled at the MTD for evaluation of their response using binominal testing. The maximum number of evaluable patients in the study is 35. The patients will then be monitored for toxicity, PK, ADA, immune responses, virus shedding, tumor response by RECIST 1.1 and survival.

Conditions

• Malignant Melanoma

Interventions

Type	Name	Description
GENETIC	delolimogene mupadenorepvec	LOAd703 is an oncolytic adenovirus encoding TMZ-CD40L and 4-1BBL
BIOLOGICAL	atezolizumab	Atezolizumab is an anti-PD-L1 antibody

Timeline

• Start date: 2020-01-28
• Primary completion: 2023-07-30
• Completion: 2023-07-30
• First posted: 2019-10-11
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

3 sites across 2 countries: United States, Sweden

Regulatory

• FDA-regulated drug study