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

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.

Timeline

Start

2014-04-09

Primary completion

2016-03-28

Completion

2018-05-18

Publications

• Bhardwaj N, Friedlander PA, Pavlick AC, Ernstoff MS, Gastman BR, Hanks BA, Curti BD, Albertini MR, Luke JJ, Blazquez AB, Balan S, Bedognetti D, Beechem JM, Crocker AS, D'Amico L, Danaher P, Davis TA, Hawthorne T, Hess BW, Keler T, Lundgren L, Morishima C, Ramchurren N, Rinchai D, Salazar AM, Salim BA, Sharon E, Vitale LA, Wang E, Warren S, Yellin MJ, Disis ML, Cheever MA, Fling SP. Flt3 ligand augments immune responses to anti-DEC-205-NY-ESO-1 vaccine through expansion of dendritic cell subsets. Nat Cancer. 2020 Dec;1(12):1204-1217. doi: 10.1038/s43018-020-00143-y. Epub 2020 Nov 16.

Drugs

Indications