NCT03419403 - UNITE Study: Understanding New Interventions With GBM ThErapy | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

July 30, 2018

Primary Completion Date

September 5, 2019

Study Completion Date

March 3, 2020

Conditions

Glioblastoma Multiforme

Interventions

DRUG

Steroid eye drops

Solution, eye drop

DRUG

Vasoconstrictor eye drops

Solution, eye drop

OTHER

Cold compress

DRUG

Ophthalmic steroid ointment

Ointment

DRUG

Depatuxizumab mafodotin

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.

DRUG

Temozolomide

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.

RADIATION

Radiation

Radiation therapy treatment planning and administration was to be performed as per local institutional guidelines.

Trial Locations (22)

2065

Royal North Shore Hospital /ID# 169673, Saint Leonards

2298

Calvary Mater Newcastle /ID# 169672, Waratah

3084

Austin Hospital /ID# 169671, Heidelberg

4029

Royal Brisbane and Women's Hospital /ID# 169674, Herston

28204

Levine Cancer Ins, Carolina Me /ID# 171271, Charlotte

60201

Northshore University Health System-Evanston /ID# 164221, Evanston

60555

CDH-Delnor Health System /ID# 169909, Warrenville

60612

Rush University Medical Center /ID# 171003, Chicago

69120

Universitaetsklinik Heidelberg /ID# 169970, Heidelberg

72076

Universitatsklinikum Tubingen /ID# 169965, Tübingen

77030

UT Health Science Ctr-Houston /ID# 164223, Houston

90033

Usc /Id# 164235, Los Angeles

93042

Klinikum Univ. Regensburg /ID# 169963, Regensburg

33612-9416

Moffitt Cancer Center /ID# 164234, Tampa

10032-3729

Columbia University Medical Center /ID# 164220, New York

76508-0001

Baylor Scott & White Medical Center- Temple /ID# 170792, Temple

04103

Universitaetsklinikum Leipzig /ID# 169969, Leipzig

1081 HV

Vrije Universiteit Medisch Centrum /ID# 170152, Amsterdam

3584 CX

Universitair Medisch Centrum Utrecht /ID# 170149, Utrecht

SE1 9RT

Guy's and St Thomas' NHS Found /ID# 207752, London

B15 2TH

Queen Elizabeth Hospital - BIRMINGHAM /ID# 200657, Birmingham

HU16 5JQ

Castle Hill Hospital /ID# 200662, Cottingham