A Study of Ad-RTS-hIL-12 With Veledimex in Combination With Nivolumab in Subjects With Glioblastoma; a Substudy to ATI001-102

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Alaunos Therapeutics
Study ID
NCT03636477
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Ad-RTS-hIL-12 — BIOLOGICAL
    * 2.0 x 10\^11 viral particles (vp) per injection * intratumoral injection of Ad-RTS-hIL-12
  • veledimex — DRUG
    * 2 doses (10mg/day, 20mg/day) * 15 oral daily doses of veledimex
  • Nivolumab — DRUG
    * 2 doses (1mg/kg, 3mg/kg) * Every 2 weeks

Study Details

This research study involves an investigational product: Ad-RTS-hIL-12 given with veledimex for production of human interleukin-12 (IL-12). IL-12 is a protein that can improve the body's natural response to disease by enhancing the ability of the immune system to kill tumor cells and may interfere with blood flow to the tumor. Nivolumab is an antibody (a kind of human protein) that is being tested to see if it will allow the body's immune system to work against glioblastoma tumors. Opdivo (Nivolumab) is currently FDA approved in the United States for melanoma (a type of skin cancer), non-small cell lung cancer, renal cell cancer (a type of kidney cancer), Hodgkin's lymphoma but is not approved in glioblastoma. Nivolumab may help your immune system detect and attack cancer cells. Ad-RTS-hIL-12 and veledimex will be given in combination with Nivolumab to enhance the IL-12 mediated effect observed to date. The main purpose of this substudy is to evaluate the safety and tolerability of a single tumoral injection of Ad-RTS-hIL-12 given with oral veledimex in combination with nivolumab.

Key Dates

Start date
Jun 18, 2018
Status verified
Aug 2025
Primary completion
Oct 15, 2020
Completion
Jun 30, 2021

Study Design

Enrollment
21 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ad-RTS-hIL-12 + veledimex in combination with nivolumab
    Intratumoral Ad-RTS-hIL-12 and varying doses of oral veledimex (activator ligand) given in combination with nivolumab via infusion.

Primary Outcome Measure

Number of Participants With Adverse Events (AEs) [ Time Frame: 2 years and 4 months ]

Locations (4)

FacilityCityStateZIPSite coordinators
Northwestern Memorial HospitalChicagoIllinois60611-
Brigham & Women's HospitalBostonMassachusetts02115-
University of MinnesotaMinneapolisMinnesota55455-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Related coverage on Hipa.ai

Find similar trials in Chicago, IL

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
Northwestern Memorial Hospital· Chicago, ILBrigham & Women's Hospital· Boston, MAUniversity of Minnesota· Minneapolis, MNThe University of Texas MD Anderson Cancer Center· Houston, TX

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