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A Phase I/II, Open-Label, Dose-Escalation Study of CDX-1401 in Patients With Malignancies Known to Express NY-ESO-1

Phase 1/Phase 2
18 Years
Open (Enrolling)
Advanced Malignancies

Thank you

Trial Information

A Phase I/II, Open-Label, Dose-Escalation Study of CDX-1401 in Patients With Malignancies Known to Express NY-ESO-1

NY-ESO-1 is a protein that is often made by some types of tumor cells, but only made by a
few types of normal cells. Because it is primarily made by cancer cells, the NY-ESO-1
protein is a promising target against which to stimulate an immune response that may destroy
cancer cells. CDX-1401 is a cancer vaccine that is specially designed to create this type
of immune response. To enhance the immune response, CDX-1401 will be given with 1 or 2
immune stimulants called Resiquimod and poly-ICLC (Hiltonol).

This clinical trial includes Phase 1 and Phase 2 segments. During the Phase 1 segment, six
groups of 6 to 24 patients will be treated with different dose levels of CDX-1401 in
combination with either one or both of the immune stimulants (Resiquimod and/or poly-ICLC).
This phase of the study will test the safety profile of the vaccine treatment, and will
assess which dose to test in future studies. During the Phase 2 segment, 14 patients whose
cancer tested positive for the NY-ESO-1 protein in laboratory testing, will receive the
study treatment to determine if it has an effect on their cancer. All patients enrolled in
either part of the study may continue to receive study treatment until their disease has
progressed or until it is necessary to stop the treatment for safety or other reasons. In
addition, all patients will be "followed" for 24 months after enrollment in order to collect
survival information.

Inclusion Criteria:

Among other criteria, patients must meet all of the following conditions to be eligible to
be in the study:

1. 18 years of age or older.

2. 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

3. Have cancer that has progressed after any therapies with curative potential or
approved salvage therapies (if such therapies exist).

4. Have evaluable or measurable tumors.

5. Have adequate blood, bone marrow, liver and kidney function as determined by
laboratory tests.

6. Have a sample of tumor tissue available for NY-ESO-1 testing at a central laboratory.

7. If of childbearing potential (male or female), agree to practice an effective form of
contraception during study treatment.

Exclusion Criteria:

Among other criteria, patients who meet any of the following conditions are NOT eligible
to be in the study:

1. Are receiving treatment with immunosuppressive or immunomodulatory agents, including
any systemic steroid (inhaled or topically applied steroids are permitted).

2. Has a known infection with HIV, HBV or HCV, or any other active infection requiring
systemic antibiotic treatment.

3. Has active central nervous system tumors.

4. Any underlying medical condition that in the Principal Investigator's opinion will
make the administration of study drug hazardous or otherwise interfere with the

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Occurrence of adverse events (side effects)

Outcome Time Frame:

12 weeks (1 cycle of study treatment)

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

September 2009

Completion Date:

September 2014

Related Keywords:

  • Advanced Malignancies
  • NYESO1
  • cancer vaccine
  • immunotherapy
  • breast cancer
  • ovarian cancer
  • non-small cell lung cancer
  • myeloma
  • sarcoma
  • melanoma
  • Resiquimod
  • Poly-ICLC
  • Hiltonol
  • esophageal cancer
  • bladder cancer
  • chondrosarcoma
  • adenocarcinoma
  • Neoplasms



Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Yale Comprehensive Cancer CenterNew Haven, Connecticut  06520-8028
Mount Sinai Comprehensive Cancer CenterMiami Beach, Florida  33140
Henry Ford Health SystemDetroit, Michigan  48202
Carolina BioOncology Institute, PLLCHuntersville, North Carolina  28078
Providence Portland Cancer CenterPortland, Oregon  97213
Weill Cornell Cancer CenterNew York, New York  10065