Clinical trial · Interventional
UNITE Study: Understanding New Interventions With GBM ThErapy
Phase 3b Study for Management of Ocular Side Effects in Subjects With EGFR-amplified Glioblastoma Receiving Depatuxizumab Mafodotin (ABT-414)
NCT03419403CI-TRIAL-00051269terminatedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was terminated because clinical development of depatuxizumab mafodotin in glioblastoma was stopped due to lack of survival benefit.
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cold compress | Other | — | UNRESOLVED |
| Depatuxizumab mafodotin | Drug | — | UNRESOLVED |
| Ophthalmic steroid ointment | Drug | — | UNRESOLVED |
| Radiation | Radiation | — | UNRESOLVED |
| Steroid eye drops | Drug | — | UNRESOLVED |
| Temozolomide | Drug | Temozolomide | ALIAS |
| Vasoconstrictor eye drops | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Standard Steroids
- description
- 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
- interventionNames
- Drug: Steroid eye drops
- Drug: Depatuxizumab mafodotin
- Drug: Temozolomide
- Radiation: Radiation
- type
- EXPERIMENTAL
- label
- Standard Steroids + Vasoconstrictor + Cold Compress
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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: * 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 * 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)
References
Publications (0)
Data not yet available
No reference posted for this study.