At a glance
ClinicalIndex Comparison Record- ✓Pathologically confirmed melanoma (locally advanced or metastatic)
- ✓Measurable disease by imaging (≥10 mm CT/MRI, ≥10 mm clinical exam, or ≥20 mm chest X-ray)
- ✓At least one injectable tumor lesion, either non-irradiated or previously irradiated with documented progression
- ✓Prior treatment with anti-PD-1 or anti-PD-L1 antibody (± anti-CTLA4)
- ✕Uveal melanoma
- ✕Rapid clinical progression due to melanoma
- ✕More than 3 brain metastases, clinically active brain metastases, or requirement for corticosteroid therapy for CNS disease
- ✕Grade 4 immune-related AEs from prior anti-PD-1/PD-L1 monotherapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I/II Trial Investigating LOAd703 in Combination With Atezolizumab in Malignant Melanoma
In Brief
A Phase 2 clinical trial evaluating delolimogene mupadenorepvec and atezolizumab for Malignant Melanoma. Completed, enrolled 24 participants across 3 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
LOAd703 is an oncolytic adenovirus encoding TMZ-CD40L and 4-1BBL
Atezolizumab is an anti-PD-L1 antibody