Ipilimumab (Immunotherapy) and MGN1703 (TLR Agonist) in Patients With Advanced Solid Malignancies

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT02668770
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • MGN1703 — DRUG
    Dose Escalation Group Starting Dose: 15 mg on Days 1, 8, and 15 of each 21 day cycle. Dose Expansion Group Starting Dose: Maximum tolerated dose from Dose Escalation Group.
  • Ipilimumab — DRUG
    Dose Escalation and Dose Expansion Group Dose: 3 mg/kg by vein on Day 8 of a 21 day cycle.

Study Details

The goal of this clinical research study is to find the highest tolerable dose of MGN1703 that can be given in combination with ipilimumab to patients with advanced tumors. The safety of this drug combination will also be studied. This is an investigational study. MGN1703 is not FDA approved or commercially available. It is currently being used for research purposes only. Ipilimumab is FDA approved and commercially available for the treatment of unresectable (cannot be removed with surgery) or metastatic (has spread) melanoma. Up to 60 participants will be enrolled in this study. All will take part at MD Anderson.

Key Dates

Start date
May 11, 2016
Status verified
Nov 2025
Primary completion
Nov 5, 2025
Completion
Nov 5, 2025

Study Design

Enrollment
28 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation Group: MGN1703 + Ipilimumab
    Participants receive MGN1703 on Days 1, 8, and 15 of all cycles as an injection under the skin. Ipilimumab dosed at 3 mg/kg once per cycle on Day 8 following MGN1703 administration. Each cycle is 21 days long. Participants receive a total of 4 treatment cycles for a total of 12 weeks on treatment.
  • Experimental: MTD Group: MGN1703 (subcutaneously) + Ipilimumab
    Dose expansion group consists of participants with advanced malignancy and cutaneous or subcutaneous manifestations. MGN1703 given subcutaneously at MTD from the Dose Escalation Group. Ipilimumab dosed at 3 mg/kg once per cycle on Day 8 following MGN1703 administration. Each cycle is 21 days long.
  • Experimental: MTD Group: MGN1703 (intratumoral injection) + Ipilimumab
    Dose expansion group consists of participants with advanced malignancy and cutaneous or or subcutaneous manifestations. MGN1703 given by intratumoral injection at MTD from the Dose Escalation Group. Ipilimumab dosed at 3 mg/kg once per cycle on Day 8 following MGN1703 administration. Each cycle is 21 days long.
  • Experimental: MTD Post XRT Group: MGN1703 (subcutaneously) + Ipilimumab
    Dose expansion group consists of participants with advanced malignancy treated with radiation (XRT) within the past 2 weeks. MGN1703 given subcutaneously at MTD from the Dose Escalation Group. Ipilimumab dosed at 3 mg/kg once per cycle on Day 8 following MGN1703 administration. Each cycle is 21 days long.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of MGN1703 with Ipilimumab [ Time Frame: 84 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
University of Texas MD Anderson Cancer Center· Houston, TX

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