Ignite Creation Date:
2025-12-24 @ 2:09 PM
Ignite Modification Date:
2026-02-22 @ 5:08 PM
Study NCT ID:
NCT02815995
Status:
COMPLETED
Last Update Posted:
2025-06-12
First Post:
2016-06-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Multi-Arm Study to Test the Efficacy of Immunotherapeutic Agents in Multiple Sarcoma Subtypes
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
A Phase II Multi-Arm Study to Test the Efficacy of Immunotherapeutic Agents in Multiple Sarcoma Subtypes
Status:
COMPLETED
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical research study is to learn if the combination of durvalumab and tremelimumab can help to control sarcoma. The safety of this drug combination will also be studied.
This is an investigational study. Durvalumab and tremelimumab 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 150 participants will be enrolled in this study. All will take part at MD Anderson.
This is an investigational study. Durvalumab and tremelimumab 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 150 participants will be enrolled in this study. All will take part at MD Anderson.
Detailed Description:
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive tremelimumab and durvalumab by vein, over about 1 hour each, every 4 weeks for up to 16 weeks (4 doses). After Week 16, you may continue to receive durvalumab alone by vein over about 1 hour for an additional 32 weeks (8 doses).
If you have a side effect related to the combination of durvalumab and tremelimumab during the first 16 weeks of the study, you may be able to switch over to receive durvalumab alone sooner than expected. This will be discussed with you.
Study Visits:
On Day 1 of Week 0:
* You will have a physical exam.
* You will have 3 EKGs in a row.
* Blood (about 1 tablespoon) and urine will be collected for routine tests. If you can become pregnant, part of this routine blood and urine sample will be used for a pregnancy test.
* Blood (about 2½ tablespoons) will be drawn for biomarker and genetic testing. Biomarkers are found in the blood and may be related to your reaction to the study drug. The type of genetic testing in this study will be performed to learn how your DNA (genetic material) may change how you respond to the study drugs.
On Day 1 of Weeks 2 and 6, blood (about 3½ tablespoons) will be drawn for routine, genetic, and biomarker testing.
On Day 1 of Week 4 and then every 4 weeks after that (Weeks 8, 12, 16, and so on) until Week 44:
* You will have a physical exam.
* Blood (about 1 tablespoon) will be drawn for routine tests.
* You will have imaging scans. You will not have these scans at Weeks 16 and 24.
On Day 1 of Weeks 10 and 14, blood (about 1 tablespoon) will be drawn for routine tests.
Length of Study:
You may receive up to 4 doses of durvalumab in combination with tremelimumab and up to an additional 8 doses of durvalumab alone. 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.
If you complete 12 months of therapy but the disease appears to get worse, you may be able to re-start treatment. The study doctor will discuss this with you.
It is expected that your participation in this study may last up to 15 months. Your participation on the study will be over after the follow-up visits.
End-of-Treatment Visit:
As soon as possible after your last dose of study drug(s):
* You will have a physical exam.
* You will have an MRI, CT, or PET/CT scan.
* Blood (about 1 tablespoon) and urine will be collected for routine tests.
* Blood (about 1 tablespoon) will be drawn for biomarker and genetic testing.
Follow-Up Visit:
About 30 days after your last dose of study drug(s):
You will have a physical exam. Blood (about 1 tablespoon) will be drawn for routine tests.
Long-Term Follow-Up
Every 3 months:
* You will have an MRI, CT, or PET/CT scan.
* You may be called to learn how you are doing and if you have started any anti-cancer treatments. If you are called, it should take about 5-10 minutes.
If you are found to be eligible to take part in this study, you will receive tremelimumab and durvalumab by vein, over about 1 hour each, every 4 weeks for up to 16 weeks (4 doses). After Week 16, you may continue to receive durvalumab alone by vein over about 1 hour for an additional 32 weeks (8 doses).
If you have a side effect related to the combination of durvalumab and tremelimumab during the first 16 weeks of the study, you may be able to switch over to receive durvalumab alone sooner than expected. This will be discussed with you.
Study Visits:
On Day 1 of Week 0:
* You will have a physical exam.
* You will have 3 EKGs in a row.
* Blood (about 1 tablespoon) and urine will be collected for routine tests. If you can become pregnant, part of this routine blood and urine sample will be used for a pregnancy test.
* Blood (about 2½ tablespoons) will be drawn for biomarker and genetic testing. Biomarkers are found in the blood and may be related to your reaction to the study drug. The type of genetic testing in this study will be performed to learn how your DNA (genetic material) may change how you respond to the study drugs.
On Day 1 of Weeks 2 and 6, blood (about 3½ tablespoons) will be drawn for routine, genetic, and biomarker testing.
On Day 1 of Week 4 and then every 4 weeks after that (Weeks 8, 12, 16, and so on) until Week 44:
* You will have a physical exam.
* Blood (about 1 tablespoon) will be drawn for routine tests.
* You will have imaging scans. You will not have these scans at Weeks 16 and 24.
On Day 1 of Weeks 10 and 14, blood (about 1 tablespoon) will be drawn for routine tests.
Length of Study:
You may receive up to 4 doses of durvalumab in combination with tremelimumab and up to an additional 8 doses of durvalumab alone. 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.
If you complete 12 months of therapy but the disease appears to get worse, you may be able to re-start treatment. The study doctor will discuss this with you.
It is expected that your participation in this study may last up to 15 months. Your participation on the study will be over after the follow-up visits.
End-of-Treatment Visit:
As soon as possible after your last dose of study drug(s):
* You will have a physical exam.
* You will have an MRI, CT, or PET/CT scan.
* Blood (about 1 tablespoon) and urine will be collected for routine tests.
* Blood (about 1 tablespoon) will be drawn for biomarker and genetic testing.
Follow-Up Visit:
About 30 days after your last dose of study drug(s):
You will have a physical exam. Blood (about 1 tablespoon) will be drawn for routine tests.
Long-Term Follow-Up
Every 3 months:
* You will have an MRI, CT, or PET/CT scan.
* You may be called to learn how you are doing and if you have started any anti-cancer treatments. If you are called, it should take about 5-10 minutes.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2016-01178 | OTHER | NCI-CTRP Clinical Trials Reporting Registry | View |