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

June 22, 2016 updated by: Celldex Therapeutics

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06519-1717
        • Yale Comprehensive Cancer Center
    • Florida
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Comprehensive Cancer Center
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
    • New York
      • New York, New York, United States, 10065
        • Weill Cornell Cancer Center
      • New York, New York, United States, 10017
        • Memorial Sloan Kettering Cancer Center
    • North Carolina
      • Huntersville, North Carolina, United States, 28078
        • Carolina BioOncology Institute, PLLC
    • Oregon
      • Portland, Oregon, United States, 97213
        • Providence Portland Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of adverse events (side effects)
Time Frame: 12 weeks (1 cycle of study treatment)
12 weeks (1 cycle of study treatment)

Secondary Outcome Measures

Outcome Measure
Time Frame
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
12 week intervals

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celldex Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (ACTUAL)

June 1, 2012

Study Completion (ACTUAL)

February 1, 2014

Study Registration Dates

First Submitted

July 28, 2009

First Submitted That Met QC Criteria

July 29, 2009

First Posted (ESTIMATE)

July 30, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

June 27, 2016

Last Update Submitted That Met QC Criteria

June 22, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDX1401-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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