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

NCT02129075 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-11-16

Study results available

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.

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

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

Sponsors & Collaborators

National Cancer Institute (NCI)
lead NIH

Principal Investigators

Nina Bhardwaj · Cancer Immunotherapy Trials Network

Study Design

Allocation: RANDOMIZED
Purpose: TREATMENT
Masking: NONE
Model: PARALLEL

Eligibility

Min Age: 18 Years
Sex: ALL
Healthy Volunteers: No

Timeline & Regulatory

Start: 2014-04-09
Primary Completion: 2016-03-28
Completion: 2018-05-18
FDA Drug: Yes

Countries

United States

Study Locations

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Entities

Diseases