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Study of Neoadjuvant Checkpoint Blockade in Patients With Surgically Resectable Undifferentiated Pleomorphic Sarcoma and Dedifferentiated Liposarcoma

2017-10-18 18:53:12 | BioPortfolio

Summary

The goal of this clinical research study is to learn if giving nivolumab alone or in combination with ipilimumab before standard of care surgery can help to control sarcoma. The safety of these drugs will also be studied.

This is an investigational study. Ipilimumab and nivolumab are FDA approved and commercially available to treat melanoma, lung cancer, and renal cell cancer. It is considered investigational to use these drugs to treat sarcoma. The study doctor can explain how the study drugs are designed to work.

Up to 40 participants will be enrolled in this study. All will take part at MD Anderson.

Description

Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups depending on the location of your tumor. This is done because no one knows if one study group is better, the same, or worse than the other group. You will have an equal chance (50/50) of being assigned to either of the groups:

Retroperitoneal sarcoma:

- If you are in Group A, you will receive nivolumab.

- If you are in Group B, you will receive nivolumab and ipilimumab in combination 1 time, and then you will only receive nivolumab.

Extremity/Trunk sarcoma:

- If you are in Group C, you will receive nivolumab along with your standard of care radiation therapy.

- If you are in Group D, you will receive nivolumab and ipilimumab in combination 1 time, then you will receive nivolumab along with your standard of care radiation therapy.

You will sign a separate consent form that describes radiation therapy and its risks.

You and the study staff will know to which group you have been assigned.

Study Drug Administration:

If you are in Group A, you will receive nivolumab by vein over about 1 hour on Days 1, 15, and 29.

If you are in Group B, you will receive nivolumab by vein over about 1 hour and ipilimumab by vein over about 90 minutes on Day 1. Then, you will receive nivolumab by vein over about 1 hour on Days 15 and 29.

If you are in Group C, you will receive nivolumab by vein over about 1 hour on Days 1, 15, 29, and 43. You will have radiation therapy 1 time each day, 5 days a week (Monday through Friday) from Day 15 to Day 47.

If you are in Group D, you will receive nivolumab by vein over about 1 hour and ipilimumab by vein over about 90 minutes on Day 1. Then, you will receive nivolumab by vein over about 1 hour on Days 15, 29, and 43. You will have radiation therapy 1 time each day, 5 days a week (Monday through Friday) from Day 15 to Day 47.

If treatment needs to be delayed more than 2 weeks because of safety reasons, the next dose(s) can be skipped and you can have any standard of care surgery as planned.

Length of Treatment:

You may continue receiving the study drug(s) until you receive your surgery. You will no longer be able to take the study drug(s) if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

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

Study Visits:

Groups A and B Before Standard of Care Surgery:

On Days 1, 15, and 29:

- You will have a physical exam.

- Blood (about 3 ½ tablespoons) will be drawn for routine tests.

- On Day 1 only, if you can become pregnant, blood (about ½ teaspoon) or urine will be collected for a pregnancy test.

- On Day 15 only, blood (about 3 tablespoons) will be drawn for biomarker and immune system testing.

- On Day 15 only, you will have a tumor biopsy for biomarker testing.

On Day 43:

- You will have an EKG.

- You will have a physical exam.

- Blood (about 6 ½ tablespoons) will be drawn to check how well your blood clots and for routine and immune system testing.

- You will have an MRI or CT scan to check the status of the disease.

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

Groups C and D Before Standard of Care Surgery:

On Days 1, 15, 29, and 43:

- You will have a physical exam.

- Blood (about 3 ½ tablespoons) will be drawn for routine tests.

- On Day 1 only, if you can become pregnant, blood (about ½ teaspoon) or urine will be collected for a pregnancy test.

- On Day 15 only, blood (about 3 tablespoons) will be drawn for biomarker and immune system testing.

- On Day 15 only, you will have a tumor biopsy for biomarker testing.

On Day 71:

- You will have an EKG.

- You will have a physical exam.

- Blood (about 6 ½ tablespoons) will be drawn to check how well your blood clots and for routine and immune system testing.

- You will have an MRI or CT scan to check the status of the disease.

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

Standard of Care Surgery:

If the doctor thinks the disease can still be removed through surgery, you will have standard of care surgery within 2 weeks after Day 43 (Groups A and B) or within 2 weeks after Day 71 (Groups C and D). You will sign a separate surgery consent form that describes the procedure and its risks. You will have a tumor biopsy at the time of surgery to collect tissue to test for any remaining sarcoma cells and to check the status of the disease.

If the disease is no longer able to be treated with surgery, you will be taken off study. Your doctor will discuss other treatment options with you.

Follow-Up Visits:

About 6 weeks after your surgery:

- You will have a physical exam.

- Blood (about 3 ½ tablespoons) will be drawn for routine, immune system, and biomarker testing.

- You will have an MRI or CT scan to check the status of the disease.

About 12 weeks after surgery and then every 12 weeks for up to 102 weeks (about 2 years):

- You will have a physical exam.

- Blood (about 6 tablespoons) will be drawn for routine and immune system testing. At 54 weeks after your surgery, this blood will also be used for biomarker testing.

- You will have an MRI or CT scan to check the status of the disease.

Long-Term Follow-Up:

A member of the study staff will contact you every 3 months for up to 2 years after surgery to ask how you are doing, how the disease may be responding to any therapy you may be taking part in, and about any anti-cancer therapy you receive.

If you need to stop taking part in this study early, the study staff will contact you to see how you are doing every 3 months until you start a new treatment for sarcoma.

This follow-up contact may be done at regularly scheduled visits, if you continue treatment at MD Anderson. If not, you will be contacted by phone, email, or letter. If you are contacted by phone, each call should last about 5 minutes.

Study Design

Conditions

Systemic Connective Tissue Disorders

Intervention

Nivolumab, Ipilimumab, Radiation Therapy

Location

University of Texas MD Anderson Cancer Center
Houston
Texas
United States
77030

Status

Recruiting

Source

M.D. Anderson Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2017-10-18T18:53:12-0400

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