CompletedPhase 1 / Phase 2NCT00948961
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedCDX-1401 in combination with Resiquimod and/or Poly-ICLC and CDX-1401

Plus 2 other study approaches.

Who it may be forAdvanced Malignancies

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jun 27, 2016 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?7 U.S. locations

Locations may change over time.

Who runs it?Celldex Therapeutics

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Celldex Therapeutics
Interventions being studied
Biological: CDX-1401 in combination with Resiquimod and/or Poly-ICLC; Biological: CDX-1401; Biological: Resiquimod; Biological: poly-ICLC
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Yale Comprehensive Cancer CenterNew Haven, Connecticut
  • Mount Sinai Comprehensive Cancer CenterMiami Beach, Florida
  • Henry Ford Health SystemDetroit, Michigan
  • Memorial Sloan Kettering Cancer CenterNew York, New York
  • Weill Cornell Cancer CenterNew York, New York
  • Carolina BioOncology Institute, PLLCHuntersville, North Carolina
  • Providence Portland Cancer CenterPortland, Oregon

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 27, 2016. Always confirm current availability with the study team.

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