Glioblastoma MultiformePhase 3NCT03419403
UNITE Study: Understanding New Interventions With GBM ThErapy
A Phase 3 study testing Steroid eye drops, Vasoconstrictor eye drops and Cold compress in people with Glioblastoma Multiforme, run by AbbVie at 22 sites in 5 countries.
Trial summary
The objective of this study was to 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 were being treated with depatuxizumab mafodotin (ABT-414). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- Steroid eye drops, Vasoconstrictor eye drops and Cold compress
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 22 sitesin 5 countries
- Study dates
- 30 Jul 2018to 3 Mar 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Participant has received prior chemotherapy or radiotherapy for cancer of the head and neck region
- Participant has received prior treatment with Gliadel wafers or any other intratumoral or intracavitary treatment
- Participant has hypersensitivity to any component of temozolomide 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
Show all 13Show fewer
- 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)
Trial locations and contacts
22 sites in 5 countries.
22 sites in 5 countries
United States9 sites
Levine Cancer Ins, Carolina Me /ID# 171271
Charlotte, North Carolina, 28204
Rush University Medical Center /ID# 171003
Chicago, Illinois, 60612
Northshore University Health System-Evanston /ID# 164221
Evanston, Illinois, 60201
UT Health Science Ctr-Houston /ID# 164223
Houston, Texas, 77030
Usc /Id# 164235
Los Angeles, California, 90033
Columbia University Medical Center /ID# 164220
New York, New York, 10032-3729
Moffitt Cancer Center /ID# 164234
Tampa, Florida, 33612-9416
Baylor Scott & White Medical Center- Temple /ID# 170792
Temple, Texas, 76508-0001
CDH-Delnor Health System /ID# 169909
Warrenville, Illinois, 60555
Australia4 sites
Austin Hospital /ID# 169671
Heidelberg, Victoria, 3084
Royal Brisbane and Women's Hospital /ID# 169674
Herston, Queensland, 4029
Royal North Shore Hospital /ID# 169673
Saint Leonards, New South Wales, 2065
Calvary Mater Newcastle /ID# 169672
Waratah, New South Wales, 2298
Germany4 sites
Universitaetsklinik Heidelberg /ID# 169970
Heidelberg, Baden-Wurttemberg, 69120
Universitaetsklinikum Leipzig /ID# 169969
Leipzig, Saxony, 04103
Klinikum Univ. Regensburg /ID# 169963
Regensburg, 93042
Universitatsklinikum Tubingen /ID# 169965
Tübingen, 72076
United Kingdom3 sites
Queen Elizabeth Hospital - BIRMINGHAM /ID# 200657
Birmingham, B15 2TH
Castle Hill Hospital /ID# 200662
Cottingham, HU16 5JQ
Guy's and St Thomas' NHS Found /ID# 207752
London, London, City of, SE1 9RT
Netherlands2 sites
Vrije Universiteit Medisch Centrum /ID# 170152
Amsterdam, 1081 HV
Universitair Medisch Centrum Utrecht /ID# 170149
Utrecht, 3584 CX
About this study
Official title: Phase 3b Study for Management of Ocular Side Effects in Subjects With EGFR-amplified Glioblastoma Receiving Depatuxizumab Mafodotin (ABT-414)
The objective of this study was to 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 were being treated with depatuxizumab mafodotin (ABT-414).
Read the detailed description
This Phase 3b open-label, randomized, exploratory study included 2 phases during the treatment period: chemoradiation therapy (radiation plus temozolomide [RT/TMZ]) and adjuvant therapy (TMZ). All participants received depatuxizumab mafodotin during both phases of the treatment period plus 1 of 3 prophylactic ophthalmologic treatments (standard steroids; standard steroids with vasoconstrictors and cold compress; and enhanced steroids with vasoconstrictors and cold compress. The study comprised a screening period of up to 7 weeks after surgery, a 6-week concomitant Chemoradiation Phase, an Adjuvant Phase beginning approximately 4 weeks after completion of chemoradiation, and a Follow-Up Phase.
- Conditions
- Glioblastoma Multiforme
- Being tested
- Steroid eye drops, Vasoconstrictor eye drops, Cold compress, Ophthalmic steroid ointment, Depatuxizumab mafodotin
- Keywords
- Glioblastoma Multiforme (GBM), Cancer, Chemoradiation therapy, Epidermal growth factor receptor-amplified glioblastoma, Radiation, Temozolomide
- Medical subject headings
- Glioblastoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Steroid eye dropsDrug
Solution, eye drop
Vasoconstrictor eye dropsDrug
Solution, eye drop
Cold compressOther
Cold compress
Ophthalmic steroid ointmentDrug
Ointment
Depatuxizumab mafodotinDrug
Also called ABT-414
During the Chemoradiation Phase, participants were to receive depatuxizumab mafodotin at 2.0 mg/kg IV infusion over 30 - 40 minutes once every 2 weeks (Day 1 of Weeks 1, 3, and 5 of the 6-week regimen). During the Adjuvant Therapy Phase, participants were to receive depatuxizumab mafodotin at 1.25 mg/kg on Day 1 (± 2 days) and Day 15 (± 2 days) of each 28-day cycle as a 30 - 40 minute infusion for 12 cycles.
TemozolomideDrug
Temozolomide was to be administered according to the local standard of care. Duration of treatment was to be 6 - 12 cycles in the adjuvant phase and at the discretion of the investigator as supported by local standard of care.
RadiationRadiation
Radiation therapy treatment planning and administration was to be performed as per local institutional guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Standard Steroids | Experimental | Steroid eye drops: 1 drop each eye, 3 times/day, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days Receives: Drug: Steroid eye drops; Drug: Depatuxizumab mafodotin; Drug: Temozolomide; Radiation: Radiation |
| Standard Steroids + Vasoconstrictor + Cold Compress | Experimental | Steroid eye drops: 1 drop each eye, 3 times/day, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Vasoconstrictor Eye Drops: 1 drop each eye 4 - 6 times on day of infusion in total (5 - 10 minutes before infusion; at end of infusion; and 2 - 4 times during the remainder of the infusion day). Continuing 4 - 6 times/day on Day 1 and Day 2 after each depatuxizumab mafodotin infusion; Cold Compress: Starting 5 minutes prior to start of infusion and continuing for 30 minutes past end of infusion, and then use at least 2 hours total/day on Days 1 - 3 with each depatuxizumab mafodotin infusion. The cold compress was to be applied in increments no longer than 30 min (could be shorter if the participant was uncomfortable). Receives: Drug: Steroid eye drops; Drug: Vasoconstrictor eye drops; Other: Cold compress; Drug: Depatuxizumab mafodotin; Drug: Temozolomide; Radiation: Radiation |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Experimental | Enhanced steroid eye drops: 1 drop each eye, 6 times/day, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Ophthalmic Steroid Ointment; applied to each eye once daily before sleep, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Vasoconstrictor Eye Drops: 1 drop each eye 4 - 6 times on day of infusion in total (5 - 10 minutes before infusion; at end of infusion; and 2 - 4 times during the remainder of the infusion day). Continuing 4 - 6 times/day on Day 1 and Day 2 after each depatuxizumab mafodotin infusion; Cold Compress: Starting 5 minutes prior to start of infusion and continuing for 30 minutes past end of infusion, and then use at least 2 hours total/day on Days 1 - 3 with each depatuxizumab mafodotin infusion. Cold compress was to be applied in increments no longer than 30 min (could be shorter if the patient is uncomfortable). Receives: Drug: Steroid eye drops; Drug: Vasoconstrictor eye drops; Other: Cold compress; Drug: Ophthalmic steroid ointment; Drug: Depatuxizumab mafodotin; Drug: Temozolomide; Radiation: Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Required a Change in Ocular Side Effect (OSE) Management
Inadequate control of ocular side effects (OSE) was defined as either a ≥ 3-line decline from baseline (≥ +0.3 on LogMAR scale) in visual acuity (with baseline correction determined at the screening ophthalmology visit)) or ≥ Grade 3 OSE severity on the Corneal Epithelial Adverse Event (CEAE) scale.
Measured: Within 8 weeks after the initial dose of depatuxizumab mafodotin
Secondary outcomes (12)
Maximum Change From Baseline on the Logarithm of the Minimum Angle of Resolution (LogMAR) Scale
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. The baseline observation is defined as the last non-missing measurement collected prior to the first dose of depatuxizumab mafodotin.
Measured: Within 8 weeks after the initial dose of depatuxizumab mafodotin
Time to Bandage Contact Lens (BCL) Intervention
The time to initiation of bandage contact lenses for those participants who required intervention due to inadequate control of ocular side effects (OSE) was calculated.
Measured: Up to 9 months after the first dose of depatuxizumab mafodotin
Number of Participants With Depatuxizumab Mafodotin Dose Modifications Due to Ocular Side Effects (OSE)
Dose modifications included depatuxizumab mafodotin withdrawal, interruption, and reductions in dose initiated due to OSEs.
Measured: From the first dose of study drug until 49 days after last depatuxizumab mafodotin administration, up to 47 weeks
Cumulative Dose of Depatuxizumab Mafodotin Received During Chemoradiation and During Adjuvant Treatment
The cumulative dose of depatuxizumab mafodotin administered was tabulated.
Measured: Up to 9 months
Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit
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).
Measured: Up to 47 weeks
Change From Baseline In Logarithm of the Minimum Angle of Resolution (LogMAR) Scale After Bandage Contact Lens (BCL) Intervention
The change on the LogMAR Scale from last assessment prior to BCL intervention to 2 weeks after BCL intervention was calculated. 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.
Measured: From the last assessment prior to BCL intervention to 2 weeks after BCL intervention
Percentage of Participants That Recovered to <3-line Decline From Baseline (≤ +0.3 LogMAR) in Visual Acuity After Bandage Contact Lens (BCL) Intervention
Recovery was defined as return to <3-line decline from baseline (≤ +0.3 LogMAR) in visual acuity after BCL intervention.
Measured: From the last assessment prior to BCL intervention to the end of BCL intervention
Number of Participants With Depatuxizumab Mafodotin Dose Modifications to Ocular Side Effects After Bandage Contact Lens (BCL) Intervention
Dose modifications included depatuxizumab mafodotin withdrawal, interruption, and reductions in dose initiated due to OSEs after BCL intervention.
Measured: From the last assessment prior to BCL intervention to the end of BCL intervention, up to 38 weeks
Time to Restart Depatuxizumab Mafodotin if Interrupted Due to Ocular Side Effects After Bandage Contact Lens (BCL) Intervention
The time to restart depatuxizumab mafodotin treatment if it was interrupted due to ocular side effects after BCL Intervention was tabulated.
Measured: From the last assessment prior to BCL intervention to the end of BCL intervention
Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention
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).
Measured: From the last assessment prior to BCL intervention to the end of BCL intervention, up to 38 weeks
Time to Ocular Side Effect (OSE) Symptom Resolution After Drug Discontinuation (Reversibility)
The time from discontinuation of depatuxizumab mafodotin to OSE symptom resolution (reversibility) was to be recorded.
Measured: From the first dose of study drug until 49 days after last depatuxizumab mafodotin administration, up to 47 weeks
Time to Re-initiation of Depatuxizumab Mafodotin After Dose Interruption
The time from dose interruption until re-initiation or permanent discontinuation of depatuxizumab mafodotin was to be recorded.
Measured: Up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start30 Jul 2018
- Primary completion5 Sep 2019
- Study completion3 Mar 2020
Why it stopped: The study was terminated because clinical development of depatuxizumab mafodotin in glioblastoma was stopped due to lack of survival benefit.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AbbVie Inc., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03419403
- Sponsor's protocol ID
- M16-534
- Other IDs
- 2017-003171-64, 2017
- Status last verified
- Mar 2021
- First submitted
- 26 Jan 2018
- Last updated
- 14 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3b Study for Management of Ocular Side Effects in Subjects With EGFR-amplified Glioblastoma Receiving Depatuxizumab Mafodotin (ABT-414)
- ClinicalTrials.gov ID
- NCT03419403
- Acronym / sponsor ID
- M16-534
- Conditions
- Glioblastoma Multiforme
- Keywords
- Glioblastoma Multiforme (GBM), Cancer, Chemoradiation therapy, Epidermal growth factor receptor-amplified glioblastoma, Radiation, Temozolomide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated because clinical development of depatuxizumab mafodotin in glioblastoma was stopped due to lack of survival benefit.
- Enrolment
- 40 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 30 Jul 2018 (actual)
- Primary completion
- 5 Sep 2019 (actual)
- Study completion
- 3 Mar 2020 (actual)
- First posted
- 5 Feb 2018 (actual)
- Results
- Posted 14 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study was to 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 were being treated with depatuxizumab mafodotin (ABT-414).
Detailed description
This Phase 3b open-label, randomized, exploratory study included 2 phases during the treatment period: chemoradiation therapy (radiation plus temozolomide [RT/TMZ]) and adjuvant therapy (TMZ). All participants received depatuxizumab mafodotin during both phases of the treatment period plus 1 of 3 prophylactic ophthalmologic treatments (standard steroids; standard steroids with vasoconstrictors and cold compress; and enhanced steroids with vasoconstrictors and cold compress. The study comprised a screening period of up to 7 weeks after surgery, a 6-week concomitant Chemoradiation Phase, an Adjuvant Phase beginning approximately 4 weeks after completion of chemoradiation, and a Follow-Up Phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Steroids | Experimental | Drug: Steroid eye drops, Drug: Depatuxizumab mafodotin, Drug: Temozolomide, Radiation: RadiationSteroid eye drops: 1 drop each eye, 3 times/day, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days |
| Standard Steroids + Vasoconstrictor + Cold Compress | Experimental | Drug: Steroid eye drops, Drug: Vasoconstrictor eye drops, Other: Cold compress, Drug: Depatuxizumab mafodotin, Drug: Temozolomide, Radiation: RadiationSteroid eye drops: 1 drop each eye, 3 times/day, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Vasoconstrictor Eye Drops: 1 drop each eye 4 - 6 times on day of infusion in total (5 - 10 minutes before infusion; at end of infusion; and 2 - 4 times during the remainder of the infusion day). Continuing 4 - 6 times/day on Day 1 and Day 2 after each depatuxizumab mafodotin infusion; Cold Compress: Starting 5 minutes prior to start of infusion and continuing for 30 minutes past end of infusion, and then use at least 2 hours total/day on Days 1 - 3 with each depatuxizumab mafodotin infusion. The cold compress was to be applied in increments no longer than 30 min (could be shorter if the participant was uncomfortable). |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Experimental | Drug: Steroid eye drops, Drug: Vasoconstrictor eye drops, Other: Cold compress, Drug: Ophthalmic steroid ointment, Drug: Depatuxizumab mafodotin, Drug: Temozolomide, Radiation: RadiationEnhanced steroid eye drops: 1 drop each eye, 6 times/day, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Ophthalmic Steroid Ointment; applied to each eye once daily before sleep, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Vasoconstrictor Eye Drops: 1 drop each eye 4 - 6 times on day of infusion in total (5 - 10 minutes before infusion; at end of infusion; and 2 - 4 times during the remainder of the infusion day). Continuing 4 - 6 times/day on Day 1 and Day 2 after each depatuxizumab mafodotin infusion; Cold Compress: Starting 5 minutes prior to start of infusion and continuing for 30 minutes past end of infusion, and then use at least 2 hours total/day on Days 1 - 3 with each depatuxizumab mafodotin infusion. Cold compress was to be applied in increments no longer than 30 min (could be shorter if the patient is uncomfortable). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- Participant has received prior chemotherapy or radiotherapy for cancer of the head and neck region
- Participant has received prior treatment with Gliadel wafers or any other intratumoral or intracavitary treatment
- Participant has hypersensitivity to any component of temozolomide 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Steroid eye dropsSolution, eye drop | Drug | Enhanced Steroids + Vasoconstrictor + Cold Compress, Standard Steroids, Standard Steroids + Vasoconstrictor + Cold Compress |
| Vasoconstrictor eye dropsSolution, eye drop | Drug | Enhanced Steroids + Vasoconstrictor + Cold Compress, Standard Steroids + Vasoconstrictor + Cold Compress |
| Cold compressCold compress | Other | Enhanced Steroids + Vasoconstrictor + Cold Compress, Standard Steroids + Vasoconstrictor + Cold Compress |
| Ophthalmic steroid ointmentOintment | Drug | Enhanced Steroids + Vasoconstrictor + Cold Compress |
| Depatuxizumab mafodotinAlso: ABT-414During the Chemoradiation Phase, participants were to receive depatuxizumab mafodotin at 2.0 mg/kg IV infusion over 30 - 40 minutes once every 2 weeks (Day 1 of Weeks 1, 3, and 5 of the 6-week regimen). During the Adjuvant Therapy Phase, participants were to receive depatuxizumab mafodotin at 1.25 mg/kg on Day 1 (± 2 days) and Day 15 (± 2 days) of each 28-day cycle as a 30 - 40 minute infusion for 12 cycles. | Drug | Enhanced Steroids + Vasoconstrictor + Cold Compress, Standard Steroids, Standard Steroids + Vasoconstrictor + Cold Compress |
| TemozolomideTemozolomide was to be administered according to the local standard of care. Duration of treatment was to be 6 - 12 cycles in the adjuvant phase and at the discretion of the investigator as supported by local standard of care. | Drug | Enhanced Steroids + Vasoconstrictor + Cold Compress, Standard Steroids, Standard Steroids + Vasoconstrictor + Cold Compress |
| RadiationRadiation therapy treatment planning and administration was to be performed as per local institutional guidelines. | Radiation | Enhanced Steroids + Vasoconstrictor + Cold Compress, Standard Steroids, Standard Steroids + Vasoconstrictor + Cold Compress |
Primary outcome
Percentage of Participants Who Required a Change in Ocular Side Effect (OSE) Management
Time frame: Within 8 weeks after the initial dose of depatuxizumab mafodotin
Inadequate control of ocular side effects (OSE) was defined as either a ≥ 3-line decline from baseline (≥ +0.3 on LogMAR scale) in visual acuity (with baseline correction determined at the screening ophthalmology visit)) or ≥ Grade 3 OSE severity on the Corneal Epithelial Adverse Event (CEAE) scale.
12 secondary outcomes
Maximum Change From Baseline on the Logarithm of the Minimum Angle of Resolution (LogMAR) Scale
Time frame: Within 8 weeks after the initial dose of depatuxizumab mafodotin
Time to Bandage Contact Lens (BCL) Intervention
Time frame: Up to 9 months after the first dose of depatuxizumab mafodotin
Number of Participants With Depatuxizumab Mafodotin Dose Modifications Due to Ocular Side Effects (OSE)
Time frame: From the first dose of study drug until 49 days after last depatuxizumab mafodotin administration, up to 47 weeks
Cumulative Dose of Depatuxizumab Mafodotin Received During Chemoradiation and During Adjuvant Treatment
Time frame: Up to 9 months
Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit
Time frame: Up to 47 weeks
Change From Baseline In Logarithm of the Minimum Angle of Resolution (LogMAR) Scale After Bandage Contact Lens (BCL) Intervention
Time frame: From the last assessment prior to BCL intervention to 2 weeks after BCL intervention
Percentage of Participants That Recovered to <3-line Decline From Baseline (≤ +0.3 LogMAR) in Visual Acuity After Bandage Contact Lens (BCL) Intervention
Time frame: From the last assessment prior to BCL intervention to the end of BCL intervention
Number of Participants With Depatuxizumab Mafodotin Dose Modifications to Ocular Side Effects After Bandage Contact Lens (BCL) Intervention
Time frame: From the last assessment prior to BCL intervention to the end of BCL intervention, up to 38 weeks
Time to Restart Depatuxizumab Mafodotin if Interrupted Due to Ocular Side Effects After Bandage Contact Lens (BCL) Intervention
Time frame: From the last assessment prior to BCL intervention to the end of BCL intervention
Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention
Time frame: From the last assessment prior to BCL intervention to the end of BCL intervention, up to 38 weeks
Time to Ocular Side Effect (OSE) Symptom Resolution After Drug Discontinuation (Reversibility)
Time frame: From the first dose of study drug until 49 days after last depatuxizumab mafodotin administration, up to 47 weeks
Time to Re-initiation of Depatuxizumab Mafodotin After Dose Interruption
Time frame: Up to 9 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AbbVie Inc. study director
AbbVie
22 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Steroid eye drops, Vasoconstrictor eye drops and Cold compress in people with Glioblastoma Multiforme, run by AbbVie at 22 sites in 5 countries.
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 13 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: stopped early, as of the sponsor's last update on 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Australia, Germany, United Kingdom, Netherlands. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants Who Required a Change in Ocular Side Effect (OSE) Management (time frame: Within 8 weeks after the initial dose of depatuxizumab mafodotin). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Apr 2021.