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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00948961
Recruitment Status : Completed
First Posted : July 30, 2009
Last Update Posted : June 27, 2016
Information provided by (Responsible Party):
Celldex Therapeutics

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Advanced Malignancies Biological: CDX-1401 in combination with Resiquimod and/or Poly-ICLC Biological: CDX-1401 Biological: Resiquimod Biological: poly-ICLC Phase 1 Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II, Open-Label, Dose-Escalation Study of CDX-1401 in Patients With Malignancies Known to Express NY-ESO-1
Study Start Date : September 2009
Actual Primary Completion Date : June 2012
Actual Study Completion Date : February 2014

Intervention Details:
  • Biological: CDX-1401 in combination with Resiquimod and/or Poly-ICLC
    CDX-1401 is administered as an injection into the skin every 2 weeks for 4 doses. It is given in combination with Resiquimod and/or poly-ICLC. Resiquimod is administered as a topical gel applied to the skin or given as an injection under the skin, and poly-ICLC is given as an injection under the skin. Depending on the treatment group assignment, either one or both of the immune stimulants will be given on the day of and the day after CDX-1401 administrations. This treatment may be repeated every 12 weeks.
  • Biological: CDX-1401
  • Biological: Resiquimod
  • Biological: poly-ICLC

Primary Outcome Measures :
  1. Occurrence of adverse events (side effects) [ Time Frame: 12 weeks (1 cycle of study treatment) ]

Secondary Outcome Measures :
  1. Objective response rate (CR/PR), disease control rate (CR/PR/SD) and time to progression, based on disease-appropriate response criteria. [ Time Frame: 12 week intervals ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 melanoma.
  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 study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00948961

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United States, Connecticut
Yale Comprehensive Cancer Center
New Haven, Connecticut, United States, 06519-1717
United States, Florida
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States, 33140
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10017
Weill Cornell Cancer Center
New York, New York, United States, 10065
United States, North Carolina
Carolina BioOncology Institute, PLLC
Huntersville, North Carolina, United States, 28078
United States, Oregon
Providence Portland Cancer Center
Portland, Oregon, United States, 97213
Sponsors and Collaborators
Celldex Therapeutics
Additional Information:
Publications of Results:
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Responsible Party: Celldex Therapeutics Identifier: NCT00948961    
Other Study ID Numbers: CDX1401-01
First Posted: July 30, 2009    Key Record Dates
Last Update Posted: June 27, 2016
Last Verified: June 2016
Keywords provided by Celldex Therapeutics:
cancer vaccine
breast cancer
ovarian cancer
non-small cell lung cancer
esophageal cancer
bladder cancer
Additional relevant MeSH terms:
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Poly I-C
Carboxymethylcellulose Sodium
Interferon Inducers
Immunologic Factors
Physiological Effects of Drugs
Gastrointestinal Agents
Antiviral Agents
Anti-Infective Agents