Ignite Creation Date:
2024-05-06 @ 1:51 AM
Last Modification Date:
2024-10-26 @ 11:10 AM
Study NCT ID:
NCT01913691
Status:
WITHDRAWN
Last Update Posted:
2019-12-17
First Post:
2013-07-28
Brief Title:
Study of the Drug Ipilimumab for Metastatic Merkel Cell Carcinoma
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Phase II Open-Label Trial of Ipilimumab for Metastatic Merkel Cell Carcinoma
Status:
WITHDRAWN
Status Verified Date:
2014-02-03
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:
Background
- Ipilimumab is a drug used to treat melanoma that cannot be treated surgically It targets a molecule found on T-cells in the human immune system Blocking these molecules on the T-cells might allow the cells to help destroy melanoma cells more effectively This drug has also been studied in other cancers such as prostate cancer and lung cancer but not yet in Merkel cell carcinoma MCC Researchers think therapy like ipilimumab that enhances the immune system may be effective against MCC They want to study how safe the drug is and its effect on the immune system and tumors
Objectives
- To determine the number of subjects with MCC who take the study drug that remain alive 12 months later
Eligibility
- Adults 18 years and older who have metastatic MCC
Design
Participants will be screened with a medical history and physical exam
Participants will receive the study drug 4 times one dose every 21 days After the 4 visits participants will receive a maintenance dose of the drug every 12 weeks until the drug is no longer beneficial
They will receive the drug through a plastic tube usually inserted in a vein on the arm
It will take 90 minutes to give each dose
At all visits participants will be screened with a medical history physical exam and blood tests Any tumors on their skin will be measured and photographed
Every 12 weeks during the study and maintenance period participants will have a CT scan Throughout the study and maintenance period they will have blood and skin tests
- Ipilimumab is a drug used to treat melanoma that cannot be treated surgically It targets a molecule found on T-cells in the human immune system Blocking these molecules on the T-cells might allow the cells to help destroy melanoma cells more effectively This drug has also been studied in other cancers such as prostate cancer and lung cancer but not yet in Merkel cell carcinoma MCC Researchers think therapy like ipilimumab that enhances the immune system may be effective against MCC They want to study how safe the drug is and its effect on the immune system and tumors
Objectives
- To determine the number of subjects with MCC who take the study drug that remain alive 12 months later
Eligibility
- Adults 18 years and older who have metastatic MCC
Design
Participants will be screened with a medical history and physical exam
Participants will receive the study drug 4 times one dose every 21 days After the 4 visits participants will receive a maintenance dose of the drug every 12 weeks until the drug is no longer beneficial
They will receive the drug through a plastic tube usually inserted in a vein on the arm
It will take 90 minutes to give each dose
At all visits participants will be screened with a medical history physical exam and blood tests Any tumors on their skin will be measured and photographed
Every 12 weeks during the study and maintenance period participants will have a CT scan Throughout the study and maintenance period they will have blood and skin tests
Detailed Description:
Background
Merkel cell carcinoma MCC is a rare aggressive neuroendocrine cancer of the skin with a mortality of approximately 33 Approximately one-third of patients present with metastatic disease for which there is no effective treatment Merkel cell polyomavirus MCV a DNA virus that expresses T antigen oncoproteins was found to be clonally integrated into the genome of the majority of MCC tumors MCC tumor progression is believed to be associated with the development of immune evasion and multiple lines of evidence higher incidence in immunocompromised populations reports of spontaneous regression responses to immune modulators and improved prognosis associated with CD8 intratumoral lymphocytes suggest that immunotherapy may improve outcomes in patients with advanced MCC Ipilimumab is a recombinant human monoclonal antibody that binds to cytotoxic Tlymphocyte- associated antigen 4 and has shown efficacy in metastatic melanoma
Objectives
Primary
-Determine overall survival at 12 months
Secondary
Determine the best overall response rate as assessed by modified RECIST immunerelated response criteria at week 12
Determine median survival
Determine disease-specific survival DSS and progression-free survival PFS
Evaluate the safety and tolerability of ipilimumab in patients with metastatic MCC
Assess biomarkers of immune activation and MCV-specific immune response
Eligibility
Patients age greater than or equal to 18 years with metastatic MCC AJCC stage 3b or 4
Immunocompromised individuals and patients with autoimmune disease are excluded
Design
Patients will enroll at the NIH Clinical Center Bethesda MD primary site or at a study sub-sites Memorial Sloan-Kettering Cancer Center New York NY University of Michigan Ann Arbor MI or University of Pennsylvania Philadelphia PA
Ipilimumab will be given at a dose of 10 mgkg as a 90-minute intravenous infusion on day 1 of each 21-day cycle for 4 cycles After 4 doses patients may receive a maintenance dose every 12 weeks until disease progression or unacceptable toxicity for up to an additional 4 doses
Imaging scans will be done at week 12 and every 12 weeks on study starting week 21
Patients will remain on-study for follow-up for 96 weeks after the last of the initial 4 doses
Response and progression will be evaluated using modified RECIST immune-related response criteria
Merkel cell carcinoma MCC is a rare aggressive neuroendocrine cancer of the skin with a mortality of approximately 33 Approximately one-third of patients present with metastatic disease for which there is no effective treatment Merkel cell polyomavirus MCV a DNA virus that expresses T antigen oncoproteins was found to be clonally integrated into the genome of the majority of MCC tumors MCC tumor progression is believed to be associated with the development of immune evasion and multiple lines of evidence higher incidence in immunocompromised populations reports of spontaneous regression responses to immune modulators and improved prognosis associated with CD8 intratumoral lymphocytes suggest that immunotherapy may improve outcomes in patients with advanced MCC Ipilimumab is a recombinant human monoclonal antibody that binds to cytotoxic Tlymphocyte- associated antigen 4 and has shown efficacy in metastatic melanoma
Objectives
Primary
-Determine overall survival at 12 months
Secondary
Determine the best overall response rate as assessed by modified RECIST immunerelated response criteria at week 12
Determine median survival
Determine disease-specific survival DSS and progression-free survival PFS
Evaluate the safety and tolerability of ipilimumab in patients with metastatic MCC
Assess biomarkers of immune activation and MCV-specific immune response
Eligibility
Patients age greater than or equal to 18 years with metastatic MCC AJCC stage 3b or 4
Immunocompromised individuals and patients with autoimmune disease are excluded
Design
Patients will enroll at the NIH Clinical Center Bethesda MD primary site or at a study sub-sites Memorial Sloan-Kettering Cancer Center New York NY University of Michigan Ann Arbor MI or University of Pennsylvania Philadelphia PA
Ipilimumab will be given at a dose of 10 mgkg as a 90-minute intravenous infusion on day 1 of each 21-day cycle for 4 cycles After 4 doses patients may receive a maintenance dose every 12 weeks until disease progression or unacceptable toxicity for up to an additional 4 doses
Imaging scans will be done at week 12 and every 12 weeks on study starting week 21
Patients will remain on-study for follow-up for 96 weeks after the last of the initial 4 doses
Response and progression will be evaluated using modified RECIST immune-related response criteria
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| 13-C-0173 | None | None | None |