Utomilumab and ISA101b Vaccination in Patients With HPV-16-Positive Incurable Oropharyngeal Cancer

Oropharyngeal Cancer Clinical Trial

Official title: Phase II Trial of Utomilumab and ISA101b Vaccination in Patients With HPV-16-Positive Incurable Oropharyngeal Cancer

Status Terminated

Clinical Trial Summary

The goal of this clinical research study is to learn if utomilumab, when given with ISA101b, is able to shrink or slow the growth of tumors in patients with incurable HPV+ oropharyngeal squamous cell carcinoma.

This is an investigational study. Utomilumab and ISA101b are not FDA approved or commercially available. They are currently being used for research purposes only. The study doctor can explain how the study drugs are designed to work.

Up to 27 participants will be enrolled. All will take part at MD Anderson.

Clinical Trial Description

Study Drug Administration:

There are 28 days in each study cycle.

You will receive utomilumab by vein every 4 weeks for up to 12 doses beginning on Cycle 1 Day

1. The drug will be given over about 1 hour each time you receive it.

You will receive ISA101b as an injection under the skin every 4 weeks for 3 doses. You will receive 2 injections each time. One may be in your arm and one in your leg.

Length of Study:

You may continue taking utomilumab for up to 1 year as long as your doctor thinks it is in your best interest. You will no longer be able to take the study drug(s) if intolerable side effects occur or if you are unable to follow study directions. You may not be able to take the study drug(s) if the disease gets worse, which is explained below.

Your participation on the study will be over after the follow-up visits.

Study Visits:

On Day 1 of Cycles 1-12:

• You will have a physical exam.

• Blood (about 1 tablespoon) will be collected for routine tests, thyroid function tests, and liver function tests.

• If you can become pregnant, blood (about ½ teaspoon) or urine will be collected for a pregnancy test.

• During Cycles 1, 2, 3, 4, 8, and 12, blood (up to 10 tablespoons) will be drawn for biomarker testing (including genetic biomarkers).

At the end of Cycle 2 and every 8 weeks after that, you will have an MRI or CT scan to check the status of the disease.

Study Continuation:

If the disease appears to have gotten worse, you may still be eligible to continue receiving your assigned study drug(s). This is because you may be benefitting from the study drug(s) even though the tumor(s) got larger. Your doctor will discuss this with you.

If this happens, your doctor will talk to you about whether or not you want to continue. If you do continue taking part in the study, you will follow the study visits as described above.

However, there are risks of continuing to receive the study drug(s) because the disease may actually be getting worse. You are still at risk for side effects due to utomilumab and ISA101b. Continuing on this study could also delay starting other treatments. The disease may get worse to the point that you are no longer able to receive other treatments. There are also risks from the additional tests that may be performed, such as biopsies and blood draws. You and your doctor will discuss these possible risks, and you will be asked to decide if you want to continue receiving the study drug(s).

End-of-Treatment and Follow-up Visits:

At about 30 days after your last study drug dose:

• You will have a physical exam.

• Blood (about 1 tablespoon) will be collected for routine tests, thyroid function tests, and liver function tests.

• If you are able to become pregnant, blood (about ½ teaspoon) or urine will be collected for a pregnancy test.

At about 70 days after your last study drug dose:

• You will have a physical exam.

• Blood (about 1 tablespoon) will be collected for routine tests, thyroid function tests, and liver function tests.

• If you are able to become pregnant, blood (about ½ teaspoon) or urine will be collected for a pregnancy test.

You will also be called every 3 months up to 1½ years and asked about your health. Each call should last about 10-15 minutes.

If you stopped taking the study drug for reasons other than the disease getting worse, you will continue to have MRI/CT scans every 8 weeks. If the disease appears to get worse, or you start a new anticancer therapy, these scans will stop. ;

Related Conditions & MeSH terms

• Lip Neoplasms
• Malignant Neoplasms of Ill-defined Secondary and Unspecified Sites
• Malignant Neoplasms of Lip Oral Cavity and Pharynx
• Neoplasms
• Oropharyngeal Cancer
• Oropharyngeal Neoplasms

• NCT number: NCT03258008
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Terminated
• Phase: Phase 2
• Start date: April 4, 2018
• Completion date: November 5, 2021