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New treatment option for Recurrent Glioblastoma
Official title Sacituzumab Govitecan in Recurrent Glioblastoma
ClinicalTrials.gov ID: NCT04559230
What this study is testing
What is Sacituzumab Govitecan?
Sacituzumab Govitecan is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for recurrent glioblastoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an open-label single arm study. All patients will receive the study drug.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Histologically confirmed IDH wild type (primary) GBM. Molecular GBM (as per cIMPACT-NOW 3) is allowed as is gliosarcoma and epithelioid glioblastoma...
- Progression following standard combined modality treatment with radiation and temozolomide chemotherapy if O6-Methylguanine-DNA Methyltransferase...
- Prior temozolomide is not required for MGMT unmethylated, but patient must have received standard doses of radiation.
You likely can't join if
- 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...
- hypertension (two or more blood pressure [BP] readings performed at screening of \> 150 mmHg systolic or \> 100 mmHg diastolic) despite optimal...
- non-healing wound, ulcer, or bone fracture
- significant cardiac arrhythmias
- untreated hypothyroidism
See the full eligibility criteria
- 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.
- Prior temozolomide is not required for MGMT unmethylated, but patient must have received standard doses of radiation.
- Inclusion of additional investigational therapy with standard frontline therapy is not exclusionary. No additional lines of therapy given for recurrent disease.
- Prior tumor-treating field therapy is not excluded, nor considered and additional line of therapy as this is often given concurrently with other therapy lines.
- Patients may have had been operated for recurrence, but if operated must have had surgery a minimum of 2 weeks prior to enrollment and have an MRI completed within 48 hours following surgery.
- No radiotherapy within the 3 months prior to the diagnosis of progression.
- Willingness to forego tumor-treatment field (Optune) therapy during participation in the study.
- Stable or decreasing dosage of steroids for 7 days prior to the baseline MRI scan.
- Recovered from toxicities of prior therapy to grade 0 or 1, except for neuropathy (Grade ≤2) and alopecia.
- ECOG performance status ≤ 2.
- Life expectancy of at least 6 months.
- Acceptable liver function:
- Bilirubin ≤ 1.5 times upper limit of normal
- AST (SGOT) and ALT (SGPT) ≤ 3.0 times upper limit of normal (ULN)
- Acceptable renal function:
- Creatinine clearance ≥30 mL/minute according to the Cockcroft and Gault formula
- Acceptable hematologic status (without hematologic support):
- ANC ≥1500 cells/uL
- Platelet count ≥100,000/uL
- Hemoglobin ≥9.0 g/dL
- All women of childbearing potential must have a negative serum pregnancy test and male and female people must agree to use effective means of contraception (surgical sterilization or the use or barrier contraception...
- Availability of biological material for central review and biomarker evaluation.
- Untreated recurrent or residual disease that is measurable by RANO criteria at time of enrollment. Multifocal and infratentorial disease is allowed.
- Positive Trop-2 expression (H-Score ≥200), as verified by central review at University of Texas Health Science Center at San Antonio (UTHSA).
- 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. 3 The subject has evidence of acute intracranial or...
- 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
- significant cardiac arrhythmias
- untreated hypothyroidism
- unhealed rectal or peri-rectal abscess
- uncontrolled active infection
- symptomatic congestive heart failure or unstable angina pectoris within 3 months prior study drug
- any history of cardiac arrhythmia or heart block
- stroke or transient ischemic attack within 6 months 8. The subject has received any of the following prior anticancer therapy:
- Non-standard radiation therapy such as brachytherapy, systemic radioisotope therapy (RIT), or intra-operative radiotherapy (IORT). Note: stereotactic radiosurgery (SRS) is allowed
- Systemic therapy (including investigational agents and small-molecule kinase inhibitors) or non-cytotoxic hormonal therapy (eg, tamoxifen) within 7 days or 5 half-lives, whichever is shorter, prior first dose of study...
- Biologic agents (antibodies, immune modulators, vaccines, cytokines) within 21 days prior to first dose of study drug
- Nitrosoureas or mitomycin C within 42 days, or metronomic/protracted low-dose chemotherapy within 14 days, or other cytotoxic chemotherapy within 28 days, prior to first dose of study drug
- Prior treatment with carmustine wafers 9. Patients with radiographically or clinically apparent leptomeningeal involvement are excluded.
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, United States
- Austin, Texas, United States
- San Antonio, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, United States; Austin, Texas, United States; San Antonio, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.