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

NCT04123470 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-09-19

Study results available
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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.

Conditions

  • Malignant Melanoma

Interventions

GENETIC

delolimogene mupadenorepvec

LOAd703 is an oncolytic adenovirus encoding TMZ-CD40L and 4-1BBL

BIOLOGICAL

atezolizumab

Atezolizumab is an anti-PD-L1 antibody

Sponsors & Collaborators

  • Precision Oncology LLC

    collaborator INDUSTRY

  • Lokon Pharma AB

    lead INDUSTRY

Principal Investigators

  • Angelica Loskog, PhD · Lokon Pharma AB

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-28
Primary Completion
2023-07-30
Completion
2023-07-30
FDA Drug
Yes

Countries

  • United States
  • Sweden

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04123470 on ClinicalTrials.gov