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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Lokon Pharma AB
Study ID
NCT04123470
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jan 28, 2020
Status verified
Sep 2024
Primary completion
Jul 30, 2023
Completion
Jul 30, 2023

Study Design

Enrollment
24 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    Delolimogene mupadenorepvec plus atezolizumab

Primary Outcome Measure

Tolerability Evaluated by NCI CTCAE v5.0 [ Time Frame: Up to 57 weeks post treatment initiation ]

Locations (2)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical Center, The Angeles Clinic and Research InstituteLos AngelesCalifornia90025-
Baylor St Luke's Medical CenterHoustonTexas77030-

Find similar trials in Los Angeles, CA

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Cedars-Sinai Medical Center, The Angeles Clinic and Research Institute· Los Angeles, CABaylor St Luke's Medical Center· Houston, TX

Related Studies