Ignite Creation Date:
2024-05-06 @ 3:01 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04491084
Status:
TERMINATED
Last Update Posted:
2024-02-28
First Post:
2020-07-21
Brief Title:
FLT3 Ligand CD40 Agonist Antibody and Stereotactic Radiotherapy
Sponsor:
Albert Einstein College of Medicine
Organization:
Albert Einstein College of Medicine
Study Overview
Official Title:
FLT3 Ligand CDX-301 CD40 Agonist Antibody CDX-1140 and Stereotactic Radiotherapy Versus Standard Therapy for Advanced Non-small Cell Lung Cancer A Phase III Randomized Trial
Status:
TERMINATED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FLT3
Brief Summary:
The purpose of this study is to test a new way of treating the most common form of lung cancer The investigators are testing a combination of radiotherapy with two new forms of immunotherapy This study is testing the safety and effectiveness of this treatment approach as compared to standard treatment options
Detailed Description:
This is a randomized open-label phase III study Subjects will be randomized in a 11 ratio to receive FLT3 ligand CDX-301 anti-CD40 antibody CDX-1140 and SBRT Arm 1 versus standard care Arm 2 Subjects on either study arm with limited disease will receive SBRT to all evident sites of active disease Subjects on Arm 1 with extensive disease will initially receive SBRT to a single site of disease but may receive additional cycles of FLT3 ligand CDX-301 anti-CD40 antibody CDX-1140 and SBRT at later time points Subjects on Arm 2 with extensive disease are expected to receive some form of standard systemic therapy eg docetaxel Subjects on Arm 2 with limited disease may also receive standard systemic therapy following completion of SBRT to all sites of evident disease at the discretion of the treating physicians All subjects will be followed closely for treatment-related toxicities Whole-body PETCT and CT imaging will be performed prior to study entry and restaging CT will be performed every 8 weeks thereafter
In the phase I component of this study subjects will be randomized between study arms until 6 subjects have been randomized to Arm 1 Study accrual will then be halted until 8 weeks after the last study subject begins treatment
If the pre-specified safety criteria are achieved in the Phase I portion of this study the study will proceed to phase II The total sample size Phase I and Phase II will be 46 subjects All 46 subjects will be included in efficacy analyses
If the pre-specified safety criteria are not achieved in the Phase I portion of this study the investigators and Celldex will review safety data from this trial as well as other trials using CDX-301 and CDX-1140 and determine if the experimental treatment regimen should be altered eg by reducing the CDX-1140 dose The study protocol would be amended accordingly and Phase I component with the new treatment regimen would be added
In the phase I component of this study subjects will be randomized between study arms until 6 subjects have been randomized to Arm 1 Study accrual will then be halted until 8 weeks after the last study subject begins treatment
If the pre-specified safety criteria are achieved in the Phase I portion of this study the study will proceed to phase II The total sample size Phase I and Phase II will be 46 subjects All 46 subjects will be included in efficacy analyses
If the pre-specified safety criteria are not achieved in the Phase I portion of this study the investigators and Celldex will review safety data from this trial as well as other trials using CDX-301 and CDX-1140 and determine if the experimental treatment regimen should be altered eg by reducing the CDX-1140 dose The study protocol would be amended accordingly and Phase I component with the new treatment regimen would be added
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