Ignite Creation Date:
2024-05-06 @ 3:49 AM
Last Modification Date:
2024-10-26 @ 11:39 AM
Study NCT ID:
NCT02386111
Status:
TERMINATED
Last Update Posted:
2018-07-26
First Post:
2015-03-06
Brief Title:
A Study of Varlilumab Anti-CD27 and Sunitinib in Patients With Metastatic Clear Cell Renal Cell Carcinoma
Sponsor:
Celldex Therapeutics
Organization:
Celldex Therapeutics
Study Overview
Official Title:
A Phase lll Study of Varlilumab in Combination With Sunitinib in Patients With Metastatic Clear Cell Renal Cell Carcinoma
Status:
TERMINATED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Portfolio re-prioritization
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 varlilumab and sunitinib The study will enroll patients with metastatic clear cell renal cell carcinoma
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
Sunitinib is a small molecule that inhibits multiple receptor tyrosine kinases RTKs some of which play a role in tumor growth and progression of cancer
This study will evaluate the safety tolerability and efficacy of the anti-CD27 antibody varlilumab in combination with sunitinib
Eligible patients that enroll in the dose escalation portion of the study will be assigned to one of three dose levels of varlilumab in combination with 50 mg of sunitinib 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 ll of the overall study
Note This Study was terminated prior to initiation of Phase II
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
Sunitinib is a small molecule that inhibits multiple receptor tyrosine kinases RTKs some of which play a role in tumor growth and progression of cancer
This study will evaluate the safety tolerability and efficacy of the anti-CD27 antibody varlilumab in combination with sunitinib
Eligible patients that enroll in the dose escalation portion of the study will be assigned to one of three dose levels of varlilumab in combination with 50 mg of sunitinib 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 ll of the overall study
Note This Study was terminated prior to initiation of Phase II
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