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Advanced MalignanciesPhase 1/2NCT00948961

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

A Phase 1/2 study testing CDX-1401 in combination with Resiquimod and/or Poly-ICLC, CDX-1401 and Resiquimod in people with Advanced Malignancies, run by Celldex Therapeutics at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Advanced Malignancies
What is being tested?
CDX-1401 in combination with Resiquimod and/or Poly-ICLC, CDX-1401 and Resiquimod
Type of treatment
Injection or infusion
How many people
70 participants
Where
7 sitesUnited States
Study dates
Sep 2009to Feb 2014
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Carolina BioOncology Institute, PLLC

    Huntersville, North Carolina, 28078

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida, 33140

  • Yale Comprehensive Cancer Center

    New Haven, Connecticut, 06519-1717

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10017

  • Weill Cornell Cancer Center

    New York, New York, 10065

  • Providence Portland Cancer Center

    Portland, Oregon, 97213

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
CDX-1401 in combination with Resiquimod and/or Poly-ICLC, CDX-1401, Resiquimod, poly-ICLC
Keywords
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
Medical subject headings
Breast Neoplasms, Ovarian Neoplasms, Carcinoma, Non-Small-Cell Lung, Neoplasms, Plasma Cell, Sarcoma, Melanoma, Esophageal Neoplasms, Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CDX-1401 in combination with Resiquimod and/or Poly-ICLCBiological

    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.

  • CDX-1401Biological

  • ResiquimodBiological

  • poly-ICLCBiological

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of adverse events (side effects)

    Measured: 12 weeks (1 cycle of study treatment)

Secondary outcomes (1)

  1. Objective response rate (CR/PR), disease control rate (CR/PR/SD) and time to progression, based on disease-appropriate response criteria.

    Measured: 12 week intervals

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionJun 2012
  4. Study completionFeb 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00948961
Sponsor's protocol ID
CDX1401-01
Status last verified
Jun 2016
First submitted
28 Jul 2009
Last updated
27 Jun 2016
Results posted
No
Data monitoring committee
No

Publications

  • Dhodapkar MV, Sznol M, Zhao B, Wang D, Carvajal RD, Keohan ML, Chuang E, Sanborn RE, Lutzky J, Powderly J, Kluger H, Tejwani S, Green J, Ramakrishna V, Crocker A, Vitale L, Yellin M, Davis T, Keler T. Induction of antigen-specific immunity with a vaccine targeting NY-ESO-1 to the dendritic cell receptor DEC-205. Sci Transl Med. 2014 Apr 16;6(232):232ra51. doi: 10.1126/scitranslmed.3008068.

    PubMed 24739759

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CDX-1401 in combination with Resiquimod and/or Poly-ICLC, CDX-1401 and Resiquimod in people with Advanced Malignancies, run by Celldex Therapeutics at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of adverse events (side effects) (time frame: 12 weeks (1 cycle of study treatment)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00948961, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2016.

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