Ignite Creation Date:
2024-05-06 @ 8:17 AM
Last Modification Date:
2024-10-26 @ 11:58 AM
Study NCT ID:
NCT02706353
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-01
First Post:
2016-03-08
Brief Title:
APX005M in Combination With Systemic Pembrolizumab in Patients With Metastatic Melanoma
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase III Dose Escalation and Cohort Expansion of Safety and Tolerability Study of Intratumoral CD40 Agonistic Monoclonal Antibody APX005M in Combination With Systemic Pembrolizumab in Patients With Metastatic Melanoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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:
You are being asked to take part in this study because you have metastatic cancer that has spread melanoma
The goal of Part 1 of this clinical research study is to find the highest tolerable dose of APX005M that can be given with pembrolizumab that can be given to patients with metastatic melanoma
The goal of Part 2 of this study is to learn if the combination can help to control metastatic melanoma
The safety of this drug combination will also be studied
This is an investigational study APX005M is not FDA approved or commercially available It is currently being used for research purposes only Pembrolizumab is FDA approved and commercially available for the treatment of metastatic melanoma The combination of these drugs to treat metastatic melanoma is investigational
The study doctor can explain how the study drug is designed to work
Up to 41 participants will be treated in this study All will take part at MD Anderson
The goal of Part 1 of this clinical research study is to find the highest tolerable dose of APX005M that can be given with pembrolizumab that can be given to patients with metastatic melanoma
The goal of Part 2 of this study is to learn if the combination can help to control metastatic melanoma
The safety of this drug combination will also be studied
This is an investigational study APX005M is not FDA approved or commercially available It is currently being used for research purposes only Pembrolizumab is FDA approved and commercially available for the treatment of metastatic melanoma The combination of these drugs to treat metastatic melanoma is investigational
The study doctor can explain how the study drug is designed to work
Up to 41 participants will be treated in this study All will take part at MD Anderson
Detailed Description:
Study Groups
If you are found to be eligible to take part in this study you will be assigned to a study group based on when you join this study Up to 4 groups of 3 participants will be enrolled in Part 1 and up to 20 participants will be enrolled in Part 2
If you are enrolled in Part 1 the dose of APX005M you receive will depend on when you join this study The first group of participants will receive the lowest dose level of APX005M Each new group will receive a higher dose of APX005M than the group before it if no intolerable side effects were seen This will continue until the highest tolerable dose of APX005M is found
If you are enrolled in Part 2 you will receive APX005M at the highest dose that was tolerated in Phase 1
All participants will receive the same dose level of pembrolizumab
Study Drug Administration
APX005M will be injected directly into 1 tumor every 3 weeks Weeks 0 3 6 and 9 for up to 4 doses
The injections may be done with or without the help of a ultrasound CT and MRI
If the doctor thinks it is needed you may need to stay in the hospital overnight or be monitored by a caregiver for 24 hours after you receive APX005M
You will receive pembrolizumab by vein 1 time every 3 weeks Weeks 0 3 6 9 and 12 The first dose of pembrolizumab will be given 1-2 days before or after your first dose of APX005M
You will be given a diary to write down any injection site reactions you may have
Study Visits
Within 1 week before your first APX005M injection
You will have a physical exam
You will have a punch biopsy or image-guided biopsy of a tumor to check the status of the disease To collect a biopsy the area of skin is numbed with anesthetic and a small cut is made to remove all or part of the affected tissue To collect a punch biopsy the area of skin is numbed with anesthetic and a small cut is made to remove all or part of the affected tissue To perform an image-guided biopsy a needle is inserted into the affected area using imaging such as CT or ultrasound to collect cells or tissue from an organ lymph node or suspected tumor mass The doctor will use the imaging to guide the needle into the area
Blood about 4½ tablespoons will be drawn to test your immune system If you can become pregnant blood about 1 teaspoon may be drawn for a pregnancy test or urine may be collected to test for pregnancy
The tumors may be measured and photographed
On Day 1 of Cycle 1
You will have a physical exam
Blood about 5½ tablespoons will be drawn for routine tests and test your immune system
The tumor may be measured and photographed
On Day 2 of Cycle 1
Your vital signs blood pressure heart rate temperature and breathing rate will be measured
Blood about 1 teaspoon will be drawn for routine tests
You will have a biopsy of one of the injected tumor sites within about 24 hours after the 1st injection to check the status of the disease
On Day 3 of Cycle 1
Your vital signs will be measured
Blood about 5 tablespoons will be drawn for routine tests and to test your immune system
On Days 8 and 15 of Cycle 1
Your vital signs will be measured
Blood about 1½ teaspoons will be drawn for routine tests
Blood about 4½ tablespoons may be drawn to test your immune system Day 8 only
On Day 1 of Cycle 2
You will have a physical exam
Blood about 5½ tablespoons will be drawn for routine tests and to test your immune system
On Days 8 and 15 of Cycle 2
Your vital signs will be measured
Blood about 1½ teaspoons will be drawn for routine tests
Blood about 4½ tablespoons may be drawn to test your immune system Day 8 only
On Day 1 of Cycle 3 3 days
Your vital signs will be measured
You will have a physical exam
You will have a biopsy of one of the injected tumors and one of the tumors for which you did not have an injection to check the status of the disease
The tumors may be measured and photographed
You will have CT MRICT andor an ultrasound to check the status of the disease
Blood about 2½ teaspoons will be drawn for routine tests If you can become pregnant a pregnancy test may be performed Urine may be collected for the pregnancy test
Blood about 4½ tablespoons will be drawn to test your immune system
On Day 1 of Cycle 4
Your vital signs will be measured
You will have a physical exam
Blood about 2½ teaspoons will be drawn for routine tests
Blood about 4½ tablespoons will be drawn to test your immune system
On Day 1 of Cycles 5-8
Your vital signs will be measured
You will have a physical exam
Blood about 1½ teaspoons will be drawn for routine tests
On Day 1 of Cycles 5 and 8 ONLY 3 days
Blood about 1½ teaspoons will be drawn for routine tests
Blood about 4½ tablespoons will be drawn to test your immune system
You may have a biopsy of one of the injected tumors and one of the tumors for which you did not have an injection to check the status of the disease Cycle 5 only
The tumors may be measured and photographed
You will have CT MRICT andor an ultrasound to check the status of the disease
Cycles beyond Cycle 8
You will have CT MRICT andor an ultrasound to check the status of the disease every 3 months for up to 2 years
Length of Treatment
You will be on study for up to 2 years You will be taken off study if the disease gets worse if intolerable side effects occur or if you are unable to follow study directions
If your doctor thinks it is in your benefit you may continue to receive pembrolizumab as standard of care after you are off this study Your doctor will describe this in more detail
Off-Study Visit
If you have to go off study early because the disease got worse or you had intolerable side effects
Your vital signs will be measured
You will have a physical exam
Blood about 1½ teaspoons will be drawn for routine tests
Blood about 4½ tablespoons will be drawn to test your immune system
Follow-Up
Within 2 weeks after your last study drug dose and every 8-12 weeks after that you may have scans to check the status of the disease Your doctor will decide what type of scans you will have
If you choose to seek care at another hospital the study staff will call you every 3 months for up to 2 years after your last study drug dose You will be asked how you are doing The calls should last about 5 minutes
If you are found to be eligible to take part in this study you will be assigned to a study group based on when you join this study Up to 4 groups of 3 participants will be enrolled in Part 1 and up to 20 participants will be enrolled in Part 2
If you are enrolled in Part 1 the dose of APX005M you receive will depend on when you join this study The first group of participants will receive the lowest dose level of APX005M Each new group will receive a higher dose of APX005M than the group before it if no intolerable side effects were seen This will continue until the highest tolerable dose of APX005M is found
If you are enrolled in Part 2 you will receive APX005M at the highest dose that was tolerated in Phase 1
All participants will receive the same dose level of pembrolizumab
Study Drug Administration
APX005M will be injected directly into 1 tumor every 3 weeks Weeks 0 3 6 and 9 for up to 4 doses
The injections may be done with or without the help of a ultrasound CT and MRI
If the doctor thinks it is needed you may need to stay in the hospital overnight or be monitored by a caregiver for 24 hours after you receive APX005M
You will receive pembrolizumab by vein 1 time every 3 weeks Weeks 0 3 6 9 and 12 The first dose of pembrolizumab will be given 1-2 days before or after your first dose of APX005M
You will be given a diary to write down any injection site reactions you may have
Study Visits
Within 1 week before your first APX005M injection
You will have a physical exam
You will have a punch biopsy or image-guided biopsy of a tumor to check the status of the disease To collect a biopsy the area of skin is numbed with anesthetic and a small cut is made to remove all or part of the affected tissue To collect a punch biopsy the area of skin is numbed with anesthetic and a small cut is made to remove all or part of the affected tissue To perform an image-guided biopsy a needle is inserted into the affected area using imaging such as CT or ultrasound to collect cells or tissue from an organ lymph node or suspected tumor mass The doctor will use the imaging to guide the needle into the area
Blood about 4½ tablespoons will be drawn to test your immune system If you can become pregnant blood about 1 teaspoon may be drawn for a pregnancy test or urine may be collected to test for pregnancy
The tumors may be measured and photographed
On Day 1 of Cycle 1
You will have a physical exam
Blood about 5½ tablespoons will be drawn for routine tests and test your immune system
The tumor may be measured and photographed
On Day 2 of Cycle 1
Your vital signs blood pressure heart rate temperature and breathing rate will be measured
Blood about 1 teaspoon will be drawn for routine tests
You will have a biopsy of one of the injected tumor sites within about 24 hours after the 1st injection to check the status of the disease
On Day 3 of Cycle 1
Your vital signs will be measured
Blood about 5 tablespoons will be drawn for routine tests and to test your immune system
On Days 8 and 15 of Cycle 1
Your vital signs will be measured
Blood about 1½ teaspoons will be drawn for routine tests
Blood about 4½ tablespoons may be drawn to test your immune system Day 8 only
On Day 1 of Cycle 2
You will have a physical exam
Blood about 5½ tablespoons will be drawn for routine tests and to test your immune system
On Days 8 and 15 of Cycle 2
Your vital signs will be measured
Blood about 1½ teaspoons will be drawn for routine tests
Blood about 4½ tablespoons may be drawn to test your immune system Day 8 only
On Day 1 of Cycle 3 3 days
Your vital signs will be measured
You will have a physical exam
You will have a biopsy of one of the injected tumors and one of the tumors for which you did not have an injection to check the status of the disease
The tumors may be measured and photographed
You will have CT MRICT andor an ultrasound to check the status of the disease
Blood about 2½ teaspoons will be drawn for routine tests If you can become pregnant a pregnancy test may be performed Urine may be collected for the pregnancy test
Blood about 4½ tablespoons will be drawn to test your immune system
On Day 1 of Cycle 4
Your vital signs will be measured
You will have a physical exam
Blood about 2½ teaspoons will be drawn for routine tests
Blood about 4½ tablespoons will be drawn to test your immune system
On Day 1 of Cycles 5-8
Your vital signs will be measured
You will have a physical exam
Blood about 1½ teaspoons will be drawn for routine tests
On Day 1 of Cycles 5 and 8 ONLY 3 days
Blood about 1½ teaspoons will be drawn for routine tests
Blood about 4½ tablespoons will be drawn to test your immune system
You may have a biopsy of one of the injected tumors and one of the tumors for which you did not have an injection to check the status of the disease Cycle 5 only
The tumors may be measured and photographed
You will have CT MRICT andor an ultrasound to check the status of the disease
Cycles beyond Cycle 8
You will have CT MRICT andor an ultrasound to check the status of the disease every 3 months for up to 2 years
Length of Treatment
You will be on study for up to 2 years You will be taken off study if the disease gets worse if intolerable side effects occur or if you are unable to follow study directions
If your doctor thinks it is in your benefit you may continue to receive pembrolizumab as standard of care after you are off this study Your doctor will describe this in more detail
Off-Study Visit
If you have to go off study early because the disease got worse or you had intolerable side effects
Your vital signs will be measured
You will have a physical exam
Blood about 1½ teaspoons will be drawn for routine tests
Blood about 4½ tablespoons will be drawn to test your immune system
Follow-Up
Within 2 weeks after your last study drug dose and every 8-12 weeks after that you may have scans to check the status of the disease Your doctor will decide what type of scans you will have
If you choose to seek care at another hospital the study staff will call you every 3 months for up to 2 years after your last study drug dose You will be asked how you are doing The calls should last about 5 minutes
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2016-00675 | REGISTRY | NCI CTRP | None |