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Sacituzumab Govitecan in Recurrent Glioblastoma

ConditionRecurrent Glioblastoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Texas Health Science Center at San Antonio

About this trial

This is an open-label single arm study. All patients will receive the study drug. The aim of the study is to compare overall survival (OS) of patients with recurrent brain tumor, known as Glioblastoma (GBM) having high levels of a protein, Trophoblast cell surface antigen 2 (Trop-2), expression on treatment with Sacituzumab Govitecan (SG) versus lomustine only which has been used in the past.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

At least 18 years of age.

Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/Ethics Committee.

Histologically confirmed IDH wild type (primary) GBM. Molecular GBM (as per cIMPACT-NOW 3) is allowed as is gliosarcoma and epithelioid glioblastoma. IDH-mutant glioma is not allowed.

Progression following standard combined modality treatment with radiation and temozolomide chemotherapy if O6-Methylguanine-DNA Methyltransferase (MGMT) methylated.

Disqualifiers

Prior treatment with bevacizumab or other VEGF inhibitors or VEGF-Receptor signaling inhibitors

The subject is receiving warfarin (or other coumarin derivatives) and is unable to switch to low molecular weight heparin (LMWH) before the first dose of study drug.

hypertension (two or more blood pressure [BP] readings performed at screening of > 150 mmHg systolic or > 100 mmHg diastolic) despite optimal treatment

non-healing wound, ulcer, or bone fracture

Trial design

Design model

Single group

Treatments tested in this trial

  • Sacituzumab Govitecan

    Drug

    Sacituzumab Govitecan will be administered by IV infusion over 3 hours for first administration and over 1 hour if tolerated. Subjects will be allowed to continue treatment until they have evidence of significant treatment-related toxicity or progressive disease.

Treatment groups

32 Participants
are divided into 1 treatment group
Group A: Sacituzumab govitecanExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Overall survival (OS)

Overall survival at 6 months including participants whose disease state has progressed

Time frame
6 months

Secondary outcomes

1

Progression free survival (PFS)

To assess the progression-free survival (PFS) of these patients on SG vs historical control of lomustine monotherapy

Time frame
6 months
2

Overall Response Rate (ORR)

To assess the Overall Response Rate (ORR) of these patients on SG by Response Assessment in Neuro-Oncology (RANO) criteria

Time frame
6 week intervals for 6 months, then every 3 months until End of Treatment ( defined as evidence of significant treatment related toxicity or progressive disease)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Health Science Center at San Antonio

Lead sponsor

Source ClinicalTrials.gov
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