Ignite Creation Date:
2024-05-06 @ 3:57 AM
Last Modification Date:
2024-10-26 @ 11:41 AM
Study NCT ID:
NCT02413827
Status:
TERMINATED
Last Update Posted:
2017-04-07
First Post:
2015-03-25
Brief Title:
A Study of Varlilumab Anti-CD27 and Ipilimumab and CDX-1401 in Patients With Unresectable Stage III or IV Melanoma
Sponsor:
Celldex Therapeutics
Organization:
Celldex Therapeutics
Study Overview
Official Title:
A Phase 1 Safety PilotPhase II Open-label Study of Varlilumab CDX-1127 in Combination With Ipilimumab and CDX-1401 in Patients With Unresectable Stage III or Stage IV Melanoma
Status:
TERMINATED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Feasibility concerns due to changes in standard of care
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a study to determine the clinical benefit how well the drug works safety and tolerability of combining a varlilumab and ipilimumab and b varlilumab ipilimumab CDX-1401 and poly-ICLC The study will enroll patients with unresectable Stage III or Stage IV melanoma
Detailed Description:
Varlilumab is a fully human monoclonal antibody that binds to a molecule called CD27 found on certain immune cells and may act to promote anti-tumor effects
Yervoy Ipilimumab is a human monoclonal antibody that blocks CTLA-4 a protein receptor that downregulates the immune system
CDX-1401 is a vaccine made of a fully human monoclonal antibody linked to NY-ESO-1 and is designed to deliver NY-ESO-1 to professional antigen presenting cells for generating robust immune responses against cancer cells expressing NY-ESO-1 CDX-1401 is administered with poly-ICLC an adjuvant that enhances vaccine-induced immune responses
This study will evaluate the safety tolerability and efficacy of varlilumab and ipilimumab with or without the addition of CDX-1401poly-ICLC in patients with melanoma
Eligible patients that enroll in the Phase I portion of the study will be assigned to one of two possible dose levels of varlilumab in combination with 3 mgkg ipilimumab The first phase of the study will test the safety profile of the combination and determine which dose of varlilumab will be studied in Phase II of the study
During Phase II up to 48 patients whose tumors do not express NY-ESO-1 will receive the recommended dose of varlilumab determined from Phase I with 3 mgkg ipilimumab Up to 24 patients whose tumors express NY-ESO-1 will receive the recommended dose of varlilumab combined with 3 mgkg ipilimumab and 1 mg CDX-1401 along with 2 mg poly-ICLC
All patients enrolled in the study will be closely monitored to determine if there is a response to the treatment as well as for any side effects that may occur
Yervoy Ipilimumab is a human monoclonal antibody that blocks CTLA-4 a protein receptor that downregulates the immune system
CDX-1401 is a vaccine made of a fully human monoclonal antibody linked to NY-ESO-1 and is designed to deliver NY-ESO-1 to professional antigen presenting cells for generating robust immune responses against cancer cells expressing NY-ESO-1 CDX-1401 is administered with poly-ICLC an adjuvant that enhances vaccine-induced immune responses
This study will evaluate the safety tolerability and efficacy of varlilumab and ipilimumab with or without the addition of CDX-1401poly-ICLC in patients with melanoma
Eligible patients that enroll in the Phase I portion of the study will be assigned to one of two possible dose levels of varlilumab in combination with 3 mgkg ipilimumab The first phase of the study will test the safety profile of the combination and determine which dose of varlilumab will be studied in Phase II of the study
During Phase II up to 48 patients whose tumors do not express NY-ESO-1 will receive the recommended dose of varlilumab determined from Phase I with 3 mgkg ipilimumab Up to 24 patients whose tumors express NY-ESO-1 will receive the recommended dose of varlilumab combined with 3 mgkg ipilimumab and 1 mg CDX-1401 along with 2 mg poly-ICLC
All patients enrolled in the study will be closely monitored to determine if there is a response to the treatment as well as for any side effects that may occur
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