Ignite Creation Date:
2024-05-06 @ 2:46 AM
Last Modification Date:
2024-10-26 @ 11:23 AM
Study NCT ID:
NCT02129075
Status:
COMPLETED
Last Update Posted:
2021-11-16
First Post:
2014-04-30
Brief Title:
A Vaccine CDX-1401 With or Without a Biologic Drug CDX-301 for the Treatment of Patients With Stage IIB-IV Melanoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Open-Label Multicenter Randomized Study of CDX-1401 a Dendritic Cell Targeting NY-ESO-1 Vaccine in Patients With Malignant Melanoma Pre-Treated With Recombinant CDX-301 a Recombinant Human Flt3 Ligand
Status:
COMPLETED
Status Verified Date:
2021-11
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:
This phase II trial studies the effect of a vaccine called CDX-1401 given with or without a biologic drug called CDX-301 in treating patients with stage IIB-IV melanoma The cancer vaccine CDX-1401 attaches to a protein that is made in tumor cells The vaccine helps the body recognize the tumor to fight the cancer The biologic drug CDX-301 may help the body make more of the tumor fighting cells known as dendritic cells Another biologic drug poly-ICLC may stimulate the immune system and help these dendritic cells mature so that they can recognize the tumor Giving CDX-301 may make the immune response to a combination of CDX-1401 and poly-ICLC better
Detailed Description:
PRIMARY OBJECTIVE
I To determine whether the immune response to NY-ESO-1 elicited by vaccination with DEC-205NY-ESO-1 fusion protein CDX-1401 CDX-1401 plus polyinosinic-polycytidylic acid stabilized with poly-L-lysine and carboxymethylcellulose poly-ICLC is substantially increased by prior expansion in the number of circulating dendritic cells DC by therapy with recombinant Flt3 ligand CDX-301 fms-related tyrosine kinase 3 ligand Flt3L
SECONDARY OBJECTIVES
I To assess the effect of the vaccine regimen on immune responses to other ongoing and nascent antitumor response antigens associated with melanoma eg PRAME MAGE-A3 p53 and gp100 as well as memory viral responses influenza A and chronic viral responses cytomegalovirus CMV Epstein-Barr virus EBV
II To assess the effect of the vaccine regimen on the frequency and phenotypic character of peripheral blood mononuclear cell PBMC subsets including DCs monocyte populations T cells and natural killer NK cells
III To assess the safety tolerability and clinical efficacy of the vaccine regimens
OUTLINE Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive recombinant Flt3 ligand CDX-301 subcutaneously SC on days -7 to -1 1-3 and 22-28 of cycle 1 and only on days 1-3 of cycle 2 Patients also receive CDX-1401 SC or intradermally ID on day 1 of each cycle and poly-ICLC SC on days 1-2 of each cycle Treatment repeats every 28 days for 4 cycles in the absence of disease progression or unacceptable toxicity
ARM II Patients receive CDX-1401 and poly-ICLC as in Arm I Treatment repeats every 28 days for 4 cycles in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 4 and 12 weeks and then annually thereafter
I To determine whether the immune response to NY-ESO-1 elicited by vaccination with DEC-205NY-ESO-1 fusion protein CDX-1401 CDX-1401 plus polyinosinic-polycytidylic acid stabilized with poly-L-lysine and carboxymethylcellulose poly-ICLC is substantially increased by prior expansion in the number of circulating dendritic cells DC by therapy with recombinant Flt3 ligand CDX-301 fms-related tyrosine kinase 3 ligand Flt3L
SECONDARY OBJECTIVES
I To assess the effect of the vaccine regimen on immune responses to other ongoing and nascent antitumor response antigens associated with melanoma eg PRAME MAGE-A3 p53 and gp100 as well as memory viral responses influenza A and chronic viral responses cytomegalovirus CMV Epstein-Barr virus EBV
II To assess the effect of the vaccine regimen on the frequency and phenotypic character of peripheral blood mononuclear cell PBMC subsets including DCs monocyte populations T cells and natural killer NK cells
III To assess the safety tolerability and clinical efficacy of the vaccine regimens
OUTLINE Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive recombinant Flt3 ligand CDX-301 subcutaneously SC on days -7 to -1 1-3 and 22-28 of cycle 1 and only on days 1-3 of cycle 2 Patients also receive CDX-1401 SC or intradermally ID on day 1 of each cycle and poly-ICLC SC on days 1-2 of each cycle Treatment repeats every 28 days for 4 cycles in the absence of disease progression or unacceptable toxicity
ARM II Patients receive CDX-1401 and poly-ICLC as in Arm I Treatment repeats every 28 days for 4 cycles in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 4 and 12 weeks and then annually thereafter
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01CA154967 | NIH | CTEP | httpsreporternihgovquickSearchU01CA154967 |
| NCI-2014-00898 | REGISTRY | None | None |
| CITN-07-FLT3L | None | None | None |
| CITN-07-FLT3L | OTHER | None | None |
| CITN-07-FLT3L | OTHER | None | None |
| P30CA015704 | NIH | None | None |