A Study of CDX-1401 in Patients With Malignancies Known to Express NY-ESO-1

Completed · Phase 1/Phase 2

Conditions studied: Advanced Malignancies

In brief

The main purpose of this study is to examine the safety and tolerability of CDX-1401 when given in combination with an immune stimulant (resiquimod) to patients with advanced cancers that are known to express the NY-ESO-1 protein.

Key facts

Study ID

NCT00948961

Run by

Celldex Therapeutics

People needed

70

Starts

2009-09-01

Expected to finish

2014-02-01

Last updated by the study team

2016-06-27

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Among other criteria, patients must meet all of the following conditions to be eligible to be in the study:
• 18 years of age or older.
• Have a cancer type that is known to express NY-ESO-1, including (but not limited to) cancer of the bladder, breast, ovary, non-small cell lung cancer, myeloma, sarcoma or melanoma.
• Have cancer that has progressed after any therapies with curative potential or approved salvage therapies (if such therapies exist).
• Have evaluable or measurable tumors.
• Have adequate blood, bone marrow, liver and kidney function as determined by laboratory tests.
• Have a sample of tumor tissue available for NY-ESO-1 testing at a central laboratory.
• If of childbearing potential (male or female), agree to practice an effective form of contraception during study treatment.

You may not qualify if…

• Among other criteria, patients who meet any of the following conditions are NOT eligible to be in the study:
• Are receiving treatment with immunosuppressive or immunomodulatory agents, including any systemic steroid (inhaled or topically applied steroids are permitted).
• Has a known infection with HIV, HBV or HCV, or any other active infection requiring systemic antibiotic treatment.
• Has active central nervous system tumors.
• Any underlying medical condition that in the Principal Investigator's opinion will make the administration of study drug hazardous or otherwise interfere with the study.

Where it is running

• Yale Comprehensive Cancer Center — New Haven, Connecticut, United States
• Mount Sinai Comprehensive Cancer Center — Miami Beach, Florida, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Weill Cornell Cancer Center — New York, New York, United States
• Carolina BioOncology Institute, PLLC — Huntersville, North Carolina, United States
• Providence Portland Cancer Center — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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