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UNITE Study: Understanding New Interventions With GBM ThErapy

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.
 
ClinicalTrials.gov Identifier: NCT03419403
Recruitment Status : Active, not recruiting
First Posted : February 5, 2018
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE January 26, 2018
First Posted Date  ICMJE February 5, 2018
Last Update Posted Date September 12, 2019
Actual Study Start Date  ICMJE July 30, 2018
Estimated Primary Completion Date February 17, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2018)
Participants who Require a Change in Ocular Side Effect (OSE) Management [ Time Frame: Up to approximately 18 weeks after initial dose of depatuxizumab mafodotin ]
Ocular Side Effect (OSE) management is defined as a participant with >= 3-line loss (+ 0.3 on LogMAR scale or equivalent) of best corrected visual acuity from baseline (with prescription at baseline for those using corrective lens), or >= Grade 3 OSE severity on the Corneal Epithelial Adverse Event [CEAE] scale.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03419403 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2018)
  • Cumulative Dose of Depatuxizumab Mafodotin [ Time Frame: Up to approximately 18 weeks after initial dose of depatuxizumab mafodotin ]
    Cumulative dose of depatuxizumab mafodotin administered (mg/kg).
  • Change from Baseline In Logarithm of the Minimum Angle of Resolution (LogMAR) Scale after Bandage Contact Lenses (BCL) Intervention [ Time Frame: Up to approximately 18 weeks after initial dose of depatuxizumab mafodotin ]
    Change on LogMAR Scale from last assessment prior to BCL intervention to 2 weeks after BCL intervention. The LogMAR scale measures visual acuity on a continuous scale, with a LogMAR value of 0 equivalent to 20/20 visual acuity. Normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment.
  • Time to OSE Symptom Resolution after Drug Discontinuation (reversibility) [ Time Frame: Up to approximately 3 years after initial dose of depatuxizumab mafodotin ]
    Time from discontinuation of depatuxizumab mafodotin to OSE symptom resolution (reversibility).
  • Time to BCL Intervention [ Time Frame: Up to approximately 18 weeks after initial dose of depatuxizumab mafodotin ]
    Time to initiation of bandage contact lenses (BCL) intervention.
  • Participants that recover to <3-line decline from Baseline (<= +0.3 LogMAR) in visual acuity after BCL Intervention [ Time Frame: Up to approximately 18 weeks after initial dose of depatuxizumab mafodotin ]
    Recovery is defined as return to <3-line decline from baseline (<= +0.3 LogMAR) in visual acuity after BCL intervention.
  • Corneal Epithelial Adverse Event (CEAE) Grade [ Time Frame: Up to approximately 3 years after initial dose of depatuxizumab mafodotin ]
    The corneal epithelial adverse event (CEAE) rating scale is designed to record symptoms associated with corneal epitheliopathy caused by antibody-drug conjugates and to grade the severity of findings. The overall CEAE grade is measured on a scale of 0 to 5, with higher values being more severe, reflecting the impact of corneal abnormalities on visual activities of daily living (ADLs). Additional detailed information is collected for specific domains that are commonly affected, with the following ranges (each in order of increasing severity): ocular discomfort (0 - 4), photophobia (0 - 3), and reading (1 - 3).
  • Time to Re-initiation of Depatuxizumab Mafodotin after Dose Interruption [ Time Frame: Up to approximately 3 years after initial dose of depatuxizumab mafodotin ]
    Time from dose interruption until re-initiation or permanent discontinuation of depatuxizumab mafodotin.
  • Participants with Depatuxizumab Mafodotin Dose Interruptions due to OSEs [ Time Frame: Up to approximately 18 weeks after initial dose of depatuxizumab mafodotin ]
    Participants with dose interruptions of depatuxizumab mafodotin due to ocular side effects (OSEs).
  • Participants with Depatuxizumab Mafodotin Dose Reductions due to OSEs [ Time Frame: Up to approximately 18 weeks after initial dose of depatuxizumab mafodotin ]
    Dose reductions of depatuxizumab mafodotin initiated due to OSEs.
  • Maximum Change from Baseline on LogMAR Scale [ Time Frame: Up to approximately 18 weeks after initial dose of depatuxizumab mafodotin ]
    The Logarithm of the Minimum Angle of Resolution (LogMAR) scale measures visual acuity on a continuous scale, with a LogMAR value of 0 equivalent to 20/20 visual acuity. Normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2018)
  • Cumulative Dose of Depatuxizumab Mafodotin [ Time Frame: Up to approximately 18 weeks after initial dose of depatuxizumab mafodotin ]
    Cumulative dose of depatuxizumab mafodotin administered (mg/kg).
  • Change on LogMAR Scale after Bandage Contact Lenses (BCL) Intervention [ Time Frame: Up to approximately 18 weeks after initial dose of depatuxizumab mafodotin ]
    Change on LogMAR Scale from last assessment prior to BCL intervention to 2 weeks after BCL intervention. The LogMAR scale is the validated tool used in ophthalmology clinical trials to evaluate change in visual acuity.
  • Time to OSE Symptom Resolution after Drug Discontinuation (reversibility) [ Time Frame: Up to approximately 3 years after initial dose of depatuxizumab mafodotin ]
    Time from discontinuation of depatuxizumab mafodotin to OSE symptom resolution (reversibility).
  • Time to BCL Intervention [ Time Frame: Up to approximately 18 weeks after initial dose of depatuxizumab mafodotin ]
    Time to initiation of bandage contact lenses (BCL) intervention.
  • Participants that recover to <3-line Loss of Visual Acuity from Baseline (+0.3 LogMAR) after BCL Intervention [ Time Frame: Up to approximately 18 weeks after initial dose of depatuxizumab mafodotin ]
    Recovery is defined as return to <3-line loss of visual acuity from baseline (+0.3 LogMAR) after BCL intervention.
  • CEAE Grade [ Time Frame: Up to approximately 3 years after initial dose of depatuxizumab mafodotin ]
    The corneal epithelial adverse event (CEAE) rating scale is designed to describe the overall severity symptoms associated with antibody-drug conjugate (ADC)-related corneal epitheliopathy under a single CEAE grade, while capturing additional information about specific domains (ocular discomfort, photophobia, and blurred vision/visual acuity) that are commonly affected.
  • Time to Re-initiation of Depatuxizumab Mafodotin after Dose Interruption [ Time Frame: Up to approximately 3 years after initial dose of depatuxizumab mafodotin ]
    Time from dose interruption until re-initiation or permanent discontinuation of depatuxizumab mafodotin.
  • Participants with Depatuxizumab Mafodotin Dose Interruptions due to OSEs [ Time Frame: Up to approximately 18 weeks after initial dose of depatuxizumab mafodotin ]
    Participants with dose interruptions of depatuxizumab mafodotin due to ocular side effects (OSEs).
  • Participants with Depatuxizumab Mafodotin Dose Reductions due to OSEs [ Time Frame: Up to approximately 18 weeks after initial dose of depatuxizumab mafodotin ]
    Dose reductions of depatuxizumab mafodotin initiated due to OSEs.
  • Maximum Change from Baseline on LogMAR Scale [ Time Frame: Up to approximately 18 weeks after initial dose of depatuxizumab mafodotin ]
    The Logarithm of the Minimum Angle of Resolution (LogMAR) scale is the validated tool used in ophthalmology clinical trials to evaluate change in visual acuity.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE UNITE Study: Understanding New Interventions With GBM ThErapy
Official Title  ICMJE Phase 3b Study for Management of Ocular Side Effects in Subjects With EGFR-amplified Glioblastoma Receiving Depatuxizumab Mafodotin (ABT-414)
Brief Summary This study will evaluate the effect of several ophthalmologic prophylactic treatment strategies for the management of ocular side effects (OSEs) in participants with epidermal growth factor receptor (EGFR)-amplified glioblastoma (GBM) who are being treated with depatuxizumab mafodotin (ABT-414). The study will include 2 phases during the treatment period: chemoradiation therapy (radiation plus temozolomide [RT/TMZ]) and adjuvant therapy (TMZ ). All participants will receive depatuxizumab mafodotin during both phases of the treatment period plus 1 of 3 prophylactic ophthalmologic treatments (standard steroids [SS], standard steroids with vasoconstrictors and cold compress [SS/VC], and enhanced steroids with vasoconstrictors and cooling compress [ES/VC]).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glioblastoma Multiforme
Intervention  ICMJE
  • Drug: Steroid eye drop
    solution, eye drop
  • Drug: Ophthalmic steroid ointment
    ointment
  • Radiation: Radiation
    radiation
  • Drug: Temozolomide
    oral
  • Drug: depatuxizumab mafodotin
    infusion
    Other Name: ABT-414
  • Other: cold compress
    cold compress
  • Drug: Vasoconstrictor eye drop
    solution, eye drop
Study Arms  ICMJE
  • Experimental: Arm B: Standard Steroids + Vasoconstrictor + Cold Compress
    Arm B: Steroid eye drop plus vasoconstrictor eye drop and cold compress plus depatuxizumab mafodotin during both the chemoradiation therapy (RT and TMZ) and the adjuvant therapy [TMZ] periods of this study.
    Interventions:
    • Drug: Steroid eye drop
    • Radiation: Radiation
    • Drug: Temozolomide
    • Drug: depatuxizumab mafodotin
    • Other: cold compress
    • Drug: Vasoconstrictor eye drop
  • Experimental: Arm A: Standard Steroid (SS)
    Arm A: Steroid Eye Drops plus depatuxizumab mafodotin during both the chemoradiation therapy (radiation [RT] and temozolomide [TMZ]) and the adjuvant therapy [TMZ] periods of this study.
    Interventions:
    • Drug: Steroid eye drop
    • Radiation: Radiation
    • Drug: Temozolomide
    • Drug: depatuxizumab mafodotin
  • Experimental: Arm C: Enhanced Steroids+Vasoconstrictor+Cold Compress (ES/VC)
    Arm C: Steroid Eye Drop plus ophthalmic steroid ointment plus vasoconstrictor eye drop and cold compresses plus depatuxizumab mafodotin during both the chemoradiation therapy (RT and TMZ) and the adjuvant therapy [TMZ] periods of this study.
    Interventions:
    • Drug: Steroid eye drop
    • Drug: Ophthalmic steroid ointment
    • Radiation: Radiation
    • Drug: Temozolomide
    • Drug: depatuxizumab mafodotin
    • Other: cold compress
    • Drug: Vasoconstrictor eye drop
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 23, 2019)
40
Original Estimated Enrollment  ICMJE
 (submitted: January 26, 2018)
90
Estimated Study Completion Date  ICMJE July 16, 2020
Estimated Primary Completion Date February 17, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Newly diagnosed glioblastoma (GBM) histologically proven, World Health Organization (WHO) grade IV GBM or WHO grade IV gliosarcoma.
  • Tumors must demonstrate epidermal growth factor receptor (EGFR) amplification.
  • Tumors must be supratentorial in location.
  • Participant must have recovered from the effects of surgery, postoperative infection, and other complications; has no significant post-operative hemorrhage.
  • Participant has a Karnofsky performance status (KPS) of 70 or higher.
  • Participant has adequate bone marrow, renal, and hepatic function.
  • Electrocardiogram without evidence of acute cardiac ischemia <= 21 days prior to randomization.
  • Participant has a life expectancy of >= 3 months.

Exclusion Criteria:

  • Participants with newly diagnosed GBM: has received prior chemotherapy or radiotherapy for cancer of the head and neck region; has received prior treatment with Gliadel wafers or any other intratumoral or intracavitary treatment.
  • Participant has hypersensitivity to any component of TMZ or dacarbazine.
  • Participant has received anti-cancer therapy (including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational therapy) within 5 years of Study Day 1.
  • Participant has clinically significant uncontrolled condition(s) as described in the protocol.
  • Participant has any medical condition which in the opinion of the investigator places the participant at an unacceptably high risk for toxicities.
  • Participant has had another active malignancy within the past 3 years except for any cancer considered cured or non-melanoma carcinoma of the skin.
  • Participant has a history of herpetic keratitis.
  • Participant is not suitable for receiving ocular steroids with conditions as described in the protocol.
  • Participant has had laser-assisted in situ keratomileusis (LASIK) procedure within the last 1 year or cataract surgery within the last 3 months.
  • Participant has a visual condition that compromises the ability to accurately measure visual acuity or assess visual activities of daily living (vADLs).
  • Participant has hepatitis B virus or hepatitis C virus infection.
  • Participant not receiving treatment with highly active antiretroviral therapy (HAART) when positive for human immunodeficiency virus (HIV).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Germany,   Netherlands,   United Kingdom,   United States
Removed Location Countries Denmark,   France
 
Administrative Information
NCT Number  ICMJE NCT03419403
Other Study ID Numbers  ICMJE M16-534
2017-003171-64 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP