NCT02129075

A Vaccine (CDX-1401) With or Without a Biologic Drug (CDX-301) for the Treatment of Patients With Stage IIB-IV Melanoma

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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-205/NY-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 (e.g., 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.

Conditions

• Cutaneous Melanoma
• Melanoma
• Melanoma of Unknown Primary
• Mucosal Melanoma
• Ocular Melanoma
• Stage IIB Cutaneous Melanoma AJCC v6 and v7
• Stage IIC Cutaneous Melanoma AJCC v6 and v7
• Stage III Cutaneous Melanoma AJCC v7
• Stage IIIA Cutaneous Melanoma AJCC v7
• Stage IIIB Cutaneous Melanoma AJCC v7
• Stage IIIC Cutaneous Melanoma AJCC v7
• Stage IV Cutaneous Melanoma AJCC v6 and v7

Interventions

Type	Name	Description
BIOLOGICAL	DEC-205/NY-ESO-1 Fusion Protein CDX-1401	Given SC or ID
DRUG	Poly ICLC	Given SC
BIOLOGICAL	Recombinant Flt3 Ligand	Given SC

Timeline

• Start date: 2014-04-09
• Primary completion: 2016-03-28
• Completion: 2018-05-18
• First posted: 2014-05-02
• Last updated: 2021-11-16
• Results posted: 2021-11-16

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study