Ignite Creation Date:
2024-05-06 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04708418
Status:
SUSPENDED
Last Update Posted:
2024-07-03
First Post:
2021-01-13
Brief Title:
A Study Evaluating Whether Pembrolizumab Alone or in Combination With CMP-001 Improves Efficacy in Patients With Operable Melanoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Randomized Study of Neoadjuvant Pembrolizumab Alone or in Combination With CMP-001 in Patients With Operable Melanoma Efficacy and Biomarker Study
Status:
SUSPENDED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Drug Supply Issues
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial studies the effect of pembrolizumab alone or in combination with CMP-001 in treating patients with melanoma that can be treated by surgery operable Immunotherapy with monoclonal antibodies such as pembrolizumab may help the bodys immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread Immunotherapy with CMP-001 may induce changes in bodys immune system and may interfere with the ability of tumor cells to grow and spread The addition of CMP-001 to pembrolizumab could improve the ability of the immune system to shrink tumors and to prevent them from returning
Detailed Description:
PRIMARY OBJECTIVE
I To evaluate the rate of pathologic complete response pCR rate in patients in each arm
SECONDARY OBJECTIVES
I To evaluate the rate of pathologic near-completemajor response pMR of the neoadjuvant therapy in each arm
II To evaluate the pathologic response rate of un-injected lesions on the combination arm Arm B
III To evaluate relapse-free survival RFS in each arm IV To evaluate overall survival OS in each arm V To evaluate the preoperative radiographic response rate in each arm VI To evaluate safety and toxicity of neoadjuvant therapy in each arm
OUTLINE Patients are randomized to 1 of 2 arms
ARM A
NEOADJUVANT PHASE Patients receive pembrolizumab intravenously IV over 30 minutes on day 1 Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity
SURGERY Patients undergo surgery 1-2 weeks after completion of neoadjuvant phase
ADJUVANT PHASE After recovery from surgery patients receive pembrolizumab IV over 30 minutes on day 1 of every other cycle Treatment repeats every 21 days for up to 16 cycles in the absence of disease progression or unacceptable toxicity
Patients also undergo computed tomography CT or positron emission tomography PETCT throughout the trial and may undergo optional biopsy at baseline and disease progression and optional collection of blood samples throughout the trial
ARM B
NEOADJUVANT PHASE Patients receive VLP-encapsulated TLR9 agonist CMP-001 CMP-001 subcutaneously SC on day 1 of cycle 1 and then intratumorally on days 8 and 15 of cycle 1 days 1 8 and 15 of cycle 2 and day 1 of cycle 3 Patients also receive pembrolizumab IV over 30 minutes on day 8 of each cycle Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity
SURGERY Patients undergo surgery 1-2 weeks after completion of neoadjuvant phase
ADJUVANT PHASE After recovery from surgery patients receive pembrolizumab IV over 30 minutes on day 1 of every other cycle Treatment repeats every 21 days for up to 16 cycles in the absence of disease progression or unacceptable toxicity
Patients also undergo CT or PETCT throughout the trial and may undergo optional biopsy at baseline and disease progression and optional collection of blood samples throughout the trial
After completion of study treatment patients are followed up at 30 days and then every 3 months if 2 years from study entry every 6 months if 2-5 years from study entry and every 12 months if 5 years from study entry for up to 10 years 15 years total follow up
I To evaluate the rate of pathologic complete response pCR rate in patients in each arm
SECONDARY OBJECTIVES
I To evaluate the rate of pathologic near-completemajor response pMR of the neoadjuvant therapy in each arm
II To evaluate the pathologic response rate of un-injected lesions on the combination arm Arm B
III To evaluate relapse-free survival RFS in each arm IV To evaluate overall survival OS in each arm V To evaluate the preoperative radiographic response rate in each arm VI To evaluate safety and toxicity of neoadjuvant therapy in each arm
OUTLINE Patients are randomized to 1 of 2 arms
ARM A
NEOADJUVANT PHASE Patients receive pembrolizumab intravenously IV over 30 minutes on day 1 Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity
SURGERY Patients undergo surgery 1-2 weeks after completion of neoadjuvant phase
ADJUVANT PHASE After recovery from surgery patients receive pembrolizumab IV over 30 minutes on day 1 of every other cycle Treatment repeats every 21 days for up to 16 cycles in the absence of disease progression or unacceptable toxicity
Patients also undergo computed tomography CT or positron emission tomography PETCT throughout the trial and may undergo optional biopsy at baseline and disease progression and optional collection of blood samples throughout the trial
ARM B
NEOADJUVANT PHASE Patients receive VLP-encapsulated TLR9 agonist CMP-001 CMP-001 subcutaneously SC on day 1 of cycle 1 and then intratumorally on days 8 and 15 of cycle 1 days 1 8 and 15 of cycle 2 and day 1 of cycle 3 Patients also receive pembrolizumab IV over 30 minutes on day 8 of each cycle Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity
SURGERY Patients undergo surgery 1-2 weeks after completion of neoadjuvant phase
ADJUVANT PHASE After recovery from surgery patients receive pembrolizumab IV over 30 minutes on day 1 of every other cycle Treatment repeats every 21 days for up to 16 cycles in the absence of disease progression or unacceptable toxicity
Patients also undergo CT or PETCT throughout the trial and may undergo optional biopsy at baseline and disease progression and optional collection of blood samples throughout the trial
After completion of study treatment patients are followed up at 30 days and then every 3 months if 2 years from study entry every 6 months if 2-5 years from study entry and every 12 months if 5 years from study entry for up to 10 years 15 years total follow up
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 |
|---|---|---|---|
| U10CA180820 | NIH | CTEP | httpsreporternihgovquickSearchU10CA180820 |
| NCI-2020-14174 | REGISTRY | None | None |
| EA6194 | OTHER | None | None |
| EA6194 | OTHER | None | None |