Ignite Creation Date:
2025-12-24 @ 3:59 PM
Ignite Modification Date:
2026-01-29 @ 12:44 PM
Study NCT ID:
NCT02426892
Status:
COMPLETED
Last Update Posted:
2023-04-18
First Post:
2015-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Nivolumab and HPV-16 Vaccination in Patients With HPV-16 Positive Incurable Solid Tumors
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Phase II Trial of Nivolumab and HPV-16 Vaccination in Patients With HPV-16-Positive Incurable Solid Tumors
Status:
COMPLETED
Status Verified Date:
2022-12
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 nivolumab combined with ISA101 can help to control cancer that has spread. The safety of the study drugs will also be studied.
This is an investigational study. ISA101 is not FDA approved or commercially available. It is currently being used for research purposes only. Nivolumab is FDA approved to treat certain types of melanoma in patients who no longer respond to other drugs. Combining ISA101 with nivolumab is investigational. The study doctor can explain how the study drugs are designed to work.
Up to 28 participants will be enrolled in this study. All will take part at MD Anderson.
This is an investigational study. ISA101 is not FDA approved or commercially available. It is currently being used for research purposes only. Nivolumab is FDA approved to treat certain types of melanoma in patients who no longer respond to other drugs. Combining ISA101 with nivolumab is investigational. The study doctor can explain how the study drugs are designed to work.
Up to 28 participants will be enrolled in this study. All will take part at MD Anderson.
Detailed Description:
Study Drug Administration:
There are 3 weeks in Cycle 1 and 2 weeks in Cycles 2 and beyond.
If you are found to be eligible to take part in this study, you will receive ISA101 by injection on Day 1 of Cycles 1, 2, and 4. You will be closely watched for the first 3 hours after each dose in order to check for any allergic reactions. Each time, you will receive 2 injections. One may be in your arm and one in your leg.
You will receive nivolumab by vein over 60 minutes on Day 8 of Cycle 1 and Day 1 of Cycles 2 and beyond.
Study Visits:
On Days 1 and 8 of Cycle 1 and Day 1 of every cycle after that:
* You will have a physical exam.
* Blood (about 4 teaspoons) will be drawn for routine tests.
On Day 1 of Cycle 1 and then 1 time a month after that, if you can become pregnant, blood (about 1 teaspoon) or urine will be collected for a pregnancy test.
At Week 11 and every 6 weeks after that, you will have a CT scan or MRI to check the status of the disease.
Additional Research Tests:
Blood (up to 20 teaspoons each time) will be drawn before you begin to receive the study treatment, before you receive ISA101 at Weeks 3 and 7, before you receive nivolumab at Weeks 9 and 11, then every 12 weeks after that. If the doctor thinks it is needed because of white blood cell recovery from stored cells, one of the every 12 week blood draws may be done earlier. These blood samples will be used for biomarker tests and tests of the immune system.
Length of Treatment:
You may take ISA101 for up to 3 doses. You may continue taking nivolumab 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 intolerable side effects occur, or if you are unable to follow study directions.
If the disease seems like it has gotten worse, you may decide to continue to receive nivolumab, if you are still eligible. It is possible the study drug may be working even though the tumor(s) got larger. However, there are risks of continuing to receive the study drug because the disease may actually be getting worse. This is described in the side effects section below.
Your participation on the study will be over after the follow-up.
Follow-up Visits:
At about 30 days and 70 days after the last study drug dose, and then as often as the doctor decides as needed, the following tests and procedures will be performed:
* You will have a physical exam.
* Blood (about 4 teaspoons) will be drawn for routine tests.
At about 30 days, 70 days, and every 6 weeks after that (if you stop the study drug\[s\] for reasons other than the disease getting worse), you will have a CT or MRI scan to check the status of the disease. If the disease gets worse, these scans will stop.
Every 3 months for up to 3 years after your last study drug dose, you will be asked how you are doing (either at a visit or by phone). The calls should last about 10 minutes.
There are 3 weeks in Cycle 1 and 2 weeks in Cycles 2 and beyond.
If you are found to be eligible to take part in this study, you will receive ISA101 by injection on Day 1 of Cycles 1, 2, and 4. You will be closely watched for the first 3 hours after each dose in order to check for any allergic reactions. Each time, you will receive 2 injections. One may be in your arm and one in your leg.
You will receive nivolumab by vein over 60 minutes on Day 8 of Cycle 1 and Day 1 of Cycles 2 and beyond.
Study Visits:
On Days 1 and 8 of Cycle 1 and Day 1 of every cycle after that:
* You will have a physical exam.
* Blood (about 4 teaspoons) will be drawn for routine tests.
On Day 1 of Cycle 1 and then 1 time a month after that, if you can become pregnant, blood (about 1 teaspoon) or urine will be collected for a pregnancy test.
At Week 11 and every 6 weeks after that, you will have a CT scan or MRI to check the status of the disease.
Additional Research Tests:
Blood (up to 20 teaspoons each time) will be drawn before you begin to receive the study treatment, before you receive ISA101 at Weeks 3 and 7, before you receive nivolumab at Weeks 9 and 11, then every 12 weeks after that. If the doctor thinks it is needed because of white blood cell recovery from stored cells, one of the every 12 week blood draws may be done earlier. These blood samples will be used for biomarker tests and tests of the immune system.
Length of Treatment:
You may take ISA101 for up to 3 doses. You may continue taking nivolumab 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 intolerable side effects occur, or if you are unable to follow study directions.
If the disease seems like it has gotten worse, you may decide to continue to receive nivolumab, if you are still eligible. It is possible the study drug may be working even though the tumor(s) got larger. However, there are risks of continuing to receive the study drug because the disease may actually be getting worse. This is described in the side effects section below.
Your participation on the study will be over after the follow-up.
Follow-up Visits:
At about 30 days and 70 days after the last study drug dose, and then as often as the doctor decides as needed, the following tests and procedures will be performed:
* You will have a physical exam.
* Blood (about 4 teaspoons) will be drawn for routine tests.
At about 30 days, 70 days, and every 6 weeks after that (if you stop the study drug\[s\] for reasons other than the disease getting worse), you will have a CT or MRI scan to check the status of the disease. If the disease gets worse, these scans will stop.
Every 3 months for up to 3 years after your last study drug dose, you will be asked how you are doing (either at a visit or by phone). The calls should last about 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-2015-01004 | REGISTRY | NCI CTRP Clinical Registry | View |