Home
Clinical Trials
DN24-02 as Adjuvant Therapy i...

DN24-02 as Adjuvant Therapy in Subjects With High Risk HER2+ Urothelial Carcinoma

Last Updated: 2017-05-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2015-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study was conducted to examine survival, disease-free survival, safety, and the magnitude of the immune response induced following administration of DN24-02 in subjects with HER2+ urothelial carcinoma.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of Datopotamab Deruxtecan Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma

NCT07129993

Urothelial Cancer Bladder Cancer

RECRUITING PHASE2/PHASE3

Durvalumab And Radiation Therapy Followed by Adjuvant Durvalumab in Patients With Urothelial Cancer (T2-4 N0-2 M0) of the Bladder

NCT02891161

Urothelial Cancer

TERMINATED PHASE1/PHASE2

RC48-ADC in Adjuvant/Salvage Treatment of HER2 Positive Non-muscle-invasive Bladder Cancer

NCT05996952

Non-muscle Invasive Bladder Cancer

NOT_YET_RECRUITING PHASE2

A Open-label, Single-arm, Multicenter, Phase II Study of RC48-ADC to Evaluate the Efficacy and Safety of Subjects With HER2 Overexpressing Locally Advanced or Metastatic Urothelial Cancer

NCT03809013

Urothelial Carcinoma

COMPLETED PHASE2

Radiation Therapy and Durvalumab With or Without Tremelimumab in Treating Participants With Unresectable, Locally Advanced, or Metastatic Bladder Cancer

NCT03601455

Bladder Urothelial Carcinoma Stage IV Bladder Cancer AJCC v8 Stage IVA Bladder Cancer AJCC v8 +1 more

ACTIVE_NOT_RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Multicenter, open-label, Phase 2 study. Subjects were randomized to either the investigational product, DN24-02, or to standard of care. Subjects randomized to the experimental arm received DN24-02 at 2-week intervals, for a total of 3 infusions. The study evaluated survival, disease-free survival, safety and the magnitude of the immune response between these 2 subject groups.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Urothelial Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

DN24-02

Subjects received infusion of DN24-02, at 2-week intervals, for a total of 3 infusions.

Group Type EXPERIMENTAL

DN24-02

Intervention Type BIOLOGICAL

DN24-02 is an autologous cellular immunotherapy product designed to stimulate an immune response against HER2/neu. It consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), which are activated ex vivo with a recombinant fusion protein, BA7072.

Standard of Care

Subjects randomized to the control arm were treated per standard of care, which in this patient population is generally observation, as there is currently no evidence that treatment with non-cisplatin containing chemotherapy is beneficial in the adjuvant setting for this patient population.

Group Type OTHER

Standard of Care

Intervention Type OTHER

Observation only until documentation of disease recurrence.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

DN24-02

Intervention Type BIOLOGICAL

Standard of Care

Observation only until documentation of disease recurrence.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Histopathologic evidence of urothelial carcinoma, based on local pathology report.
* High risk urothelial carcinoma, in subjects with or without prior neoadjuvant chemotherapy, defined as positive lymph node status (N+), or pathological stage ≥ pathological tumor (pT2) in patients who either have negative lymph node status (N0) or have no evaluable lymph nodes (Nx).
* Radical surgical resection was performed ≤ 84 days (12 weeks) prior to registration.
* No evidence of residual disease or metastasis following surgical resection which includes: absence of invasive cancer at the margins in the surgical specimens and confirmation by CT scan of chest, abdomen and pelvis obtained at least 28 days following surgical resection and ≤ 28 days prior to registration.
* HER2/neu tissue expression ≥ 1+ by immunohistochemistry (IHC). Available biopsy specimens from the primary tumor and involved lymph nodes are be submitted to the central pathology laboratory prior to registration for confirmation of HER2/neu tissue expression.
* Last neoadjuvant chemotherapy treatment administered at least 60 days prior to registration.
* Left ventricular ejection fraction ≥ 50% on multigated acquisition (MUGA) scan or echocardiogram obtained at least 28 days following surgery and ≤ 28 days prior to registration.
* Women of child-bearing potential have a negative serum pregnancy test result ≤ 28 days prior to registration and agree not to breastfeed during investigational treatment with DN24-02 and for 28 days following the final infusion of DN24-02.
* All males and premenopausal females who have not been surgically sterilized have agreed to practice a method of birth control considered by the Investigator to be effective and medically acceptable for at least 14 days prior to registration, throughout treatment, and for 28 days following the final infusion of DN24-02.
* Adequate hematologic, renal, and liver function.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

Exclusion Criteria

* A history of stage III or greater non-urothelial cancer. Exceptions include: Subject with basal or squamous cell skin cancers that has been adequately treated who are disease-free at the time of registration. Subjects who have been disease-free and off treatment for ≥ 10 years at the time of registration.
* A history of stage I or II non-urothelial cancer. Exceptions include: Subjects who have been disease-free and off treatment for ≥ 3 years at the time of registration. Subjects with incidental prostate cancer diagnosed at the time of cystoprostatectomy. Subjects with basal or squamous cell skin cancer.
* Partial cystectomy in the setting of bladder cancer primary tumor.
* Partial nephrectomy in the setting of renal pelvis primary tumor.
* Adjuvant systemic therapy for urothelial or prostatic carcinoma following surgical resection.
* Adjuvant radiation therapy for urothelial or prostatic carcinoma following surgical resection.
* Incidental prostate cancer with detectable post-operative (radical cystoprostatectomy) prostate specific antigen (PSA) levels ≤ 28 days prior to registration.
* Any major surgery (e.g., surgery requiring general anesthesia) ≤ 28 days prior to registration.
* Systemic treatment on any investigational clinical trial ≤ 28 days prior to registration.
* Systemic glucocorticoid or immunosuppressive therapy use ≤ 28 days prior to registration.
* Any infection requiring parenteral antibiotic therapy or causing fever (i.e., temperature \> 100.5°F or \> 38.1°C) ≤ 7 days prior to registration.
* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to DN24-02 or Granulocyte-macrophage colony-stimulating factor (GM-CSF).
* Any medical intervention, has any other condition, or has any other circumstance which, in the opinion of the Investigator or the Dendreon Medical Monitor, could compromise adherence with study requirements or otherwise compromise the study's objectives.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Robert Israel, MD

Role: STUDY_DIRECTOR

Valeant Pharmaceuticals North America LLC

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mayo Clinic Hospital

Phoenix, Arizona, United States

Site Status

Mayo Clinic Arizona

Scottsdale, Arizona, United States

Site Status

City of Hope Medical Center

Duarte, California, United States

Site Status

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status

Genesis Research

San Diego, California, United States

Site Status

Stanford University Hospital

Stanford, California, United States

Site Status

University of Colorado, Anschutz Cancer Pavilion

Aurora, Colorado, United States

Site Status

The Urology Center of Colorado

Denver, Colorado, United States

Site Status

Neag Comprehensive Cancer Center/University of Connecticut Health Center

Farmington, Connecticut, United States

Site Status

Yale University School of Medicine

New Haven, Connecticut, United States

Site Status

Urological Research Network

Hialeah, Florida, United States

Site Status

University of Miami Cancer Center

Miami, Florida, United States

Site Status

H. Lee Moffitt Cancer Center & Research Institute, Inc.

Tampa, Florida, United States

Site Status

Emory Department of Urology, The Emory Clinic Inc, Emory University Hospital

Atlanta, Georgia, United States

Site Status

American Red Cross

Atlanta, Georgia, United States

Site Status

University of Chicago Medical Center

Chicago, Illinois, United States

Site Status

Indiana University

Indianapolis, Indiana, United States

Site Status

Kansas City Urology Care

Overland Park, Kansas, United States

Site Status

University of Kansas Cancer Center

Westwood, Kansas, United States

Site Status

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Site Status

Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Lahey Clinic

Burlington, Massachusetts, United States

Site Status

Michigan Institute of Urology

Troy, Michigan, United States

Site Status

University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

GU Research Center, LLC

Omaha, Nebraska, United States

Site Status

John Theurer Cancer Center, Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status