Immunotherapy with TLR Agonist for Cancer

Recruiting in Palo Alto (17 mi)

David S Hong | MD Anderson Cancer Center

Overseen byDavid Hong, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Adults with advanced solid tumors that standard therapy has failed to cure or for which no standard treatment exists can join this trial. They must have been off other treatments for at least 4 weeks, have a stable health status, and agree to use contraception. People with severe allergies to the study drugs, recent vaccines, certain infections or diseases like severe autoimmune disorders cannot participate.

Inclusion Criteria

Patients must be willing and able to review, understand, and provide written consent before study enrollment

You have a disease that can be measured using specific criteria.

My cancer is advanced or has spread, and standard treatments haven't worked or aren't available.

+8 more

Exclusion Criteria

I have not had radiation therapy in the last 4 weeks.

I don't have any health issues that could make the study drug dangerous for me or affect the study results.

I am HIV-positive on HAART or have Hepatitis B/C and am receiving treatment.

+11 more

Participant Groups

The trial is testing the highest dose of MGN1703 (not FDA approved) that's safe when given with ipilimumab (FDA approved for melanoma) in patients with advanced tumors. Researchers want to see how well these two drugs work together and what side effects they might cause.

4Treatment groups

Experimental Treatment

Group I: MTD Post XRT Group: MGN1703 (subcutaneously) + IpilimumabExperimental Treatment2 Interventions

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.

Group II: MTD Group: MGN1703 (subcutaneously) + IpilimumabExperimental Treatment2 Interventions

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.

Group III: MTD Group: MGN1703 (intratumoral injection) + IpilimumabExperimental Treatment2 Interventions

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.

Group IV: Dose Escalation Group: MGN1703 + IpilimumabExperimental Treatment2 Interventions

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.

Ipilimumab is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Yervoy for: