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

Melanoma Clinical Trial

Official title: A Phase I Trial of Ipilimumab (Immunotherapy) and MGN1703 (TLR Agonist) in Patients With Advanced Solid Malignancies

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial Description

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to a dose level of MGN1703 based on when you joined this study. Up to 4 dose levels of MGN1703 will be tested. Up to 6 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level of MGN1703. Each new group will receive a higher dose of MGN1703 than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of MGN1703 is found. This is called dose escalation.

In another part of the study (called dose expansion) up to 3 groups of up to 12 additional participants will be enrolled. Two (2) groups will receive MGN1703 at the highest tolerable dose that was found in dose escalation. One (1) group will receive the first dose level of MGN1703 (if it is found to be tolerable). The study doctor will tell you which dose of MGN1703 you will receive.

All participants will receive the same dose level of ipilimumab. You will receive ipilimumab at standard doses.

Study Drug Administration:

Each study cycle is 21 days.

You will be given MGN1703 as an injection under the skin on Days 1, 8, and 15 of each cycle. Each administration will be between 1-4 injections in multiple parts of your body (such as your upper arms and thighs, your abdomen and thighs, or your abdomen and upper arms). The study doctor will tell you how many times you will be injected.

If you are in dose expansion, you may receive MGN1703 as an injection directly into the tumor. The study doctor will tell you if you will receive the study drug this way.

You will also receive ipilimumab by vein over about 90 minutes on Day 8 of Cycles 1-4.

Study Visits:

During Week 1 of every cycle, blood (about 1 teaspoon) will be drawn for routine tests.

During Week 2 of Cycles 1-4, you will have a physical exam.

During Week 3 of Cycles 1 and 3, blood (about 5 teaspoons) will be drawn for routine tests and biomarker testing.

During Week 3 of Cycles 2 and 4:

• Blood (about 5 teaspoons) will be drawn for routine tests and biomarker testing.

• Urine will be collected for routine tests.

• You will have an EKG.

• You will have imaging scans to check the status of the disease.

• If you can become pregnant, blood (about 1 teaspoon) will be drawn for a pregnancy test.

If you are in dose expansion and depending on when you join the study, on Day 1 of Cycle 3 you will have a biopsy for biomarker testing (including genetic biomarkers).

During Cycle 4 and then every even-numbered cycle after that (Cycles 6, 8, 10, and so on):

• You will have a physical exam.

• Blood (about 5 teaspoons) will be drawn for routine tests and biomarker testing.

• You will have imaging scans to check the status of the disease. After 1 year on study, you will have these scans every 4 cycles.

During Cycle 4 and then every 4 cycles after that (Cycles 8, 12, 16, and so on):

• Urine will be collected for routine tests.

• You will have an EKG.

• If you can become pregnant, blood (about 1 teaspoon) will be drawn for a pregnancy test.

Every 30 days for 90 days after your last dose of study drug, you will be called by a member of the study staff and asked about any new anticancer drugs you may have started and how you are feeling. You may also be asked these questions during a routine clinic visit or this information may be collected from your medical record. If you are called, each call should last about 10-15 minutes.

Length of Study:

You may receive MGN1703 in combination with ipilimumab for up to 4 cycles. After that, you may continue taking MGN1703 alone for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

You participation on this study will be over 90 days after your last dose of study drug. ;

Related Conditions & MeSH terms

• Advanced Cancers
• Melanoma
• Neoplasms

• NCT number: NCT02668770
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: May 11, 2016
• Completion date: May 31, 2025