RECRUITING

Sacituzumab Govitecan in Recurrent Glioblastoma

Conditions

Recurrent Glioblastoma Trophoblast Cell-Surface Antigen 2 Trop-2 Sacituzumab Govitecan

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase II, Multicenter, Prospective Study of Sacituzumab Govitecan in Recurrent Glioblastoma

Quick Facts

Study Start:2022-01-06

Study Completion:2026-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04559230

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. At least 18 years of age. 2. 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. 3. 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. 4. 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. 5. 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. 6. No radiotherapy within the 3 months prior to the diagnosis of progression. 7. Willingness to forego tumor-treatment field (Optune) therapy during participation in the study. 8. Stable or decreasing dosage of steroids for 7 days prior to the baseline MRI scan. 9. Recovered from toxicities of prior therapy to grade 0 or 1, except for neuropathy (Grade ≤2) and alopecia. 10. ECOG performance status ≤ 2. 11. Life expectancy of at least 6 months. 12. Acceptable liver function: * Bilirubin ≤ 1.5 times upper limit of normal * AST (SGOT) and ALT (SGPT) ≤ 3.0 times upper limit of normal (ULN) 13. Acceptable renal function: 14. Acceptable hematologic status (without hematologic support): * ANC ≥1500 cells/uL * Platelet count ≥100,000/uL * Hemoglobin ≥9.0 g/dL 15. All women of childbearing potential must have a negative serum pregnancy test and male and female subjects must agree to use effective means of contraception (surgical sterilization or the use or barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) with their partner from entry into the study through 6 months after the last dose. 16. Availability of biological material for central review and biomarker evaluation. 17. Untreated recurrent or residual disease that is measurable by RANO criteria at time of enrollment. Multifocal and infratentorial disease is allowed. 18. Positive Trop-2 expression (H-Score ≥200), as verified by central review at University of Texas Health Science Center at San Antonio (UTHSA).	1. Prior treatment with bevacizumab or other VEGF inhibitors or VEGF-Receptor signaling inhibitors 2. 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. 4. The subject is unable to undergo MRI scan (eg, has pacemaker). 5. The subject has received enzyme-inducing anti-epileptic agents within 14 days of study drug (eg, carbamazepine, phenytoin, phenobarbital, primidone). 6. The subject is pregnant or breast-feeding. 7. The subject has serious intercurrent illness, such as: * 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 drug * 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.

Inclusion Criteria

Exclusion Criteria

1. At least 18 years of age.
2. 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.
3. 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.
4. 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.
5. 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.
6. No radiotherapy within the 3 months prior to the diagnosis of progression.
7. Willingness to forego tumor-treatment field (Optune) therapy during participation in the study.
8. Stable or decreasing dosage of steroids for 7 days prior to the baseline MRI scan.
9. Recovered from toxicities of prior therapy to grade 0 or 1, except for neuropathy (Grade ≤2) and alopecia.
10. ECOG performance status ≤ 2.
11. Life expectancy of at least 6 months.
12. Acceptable liver function:
* Bilirubin ≤ 1.5 times upper limit of normal
* AST (SGOT) and ALT (SGPT) ≤ 3.0 times upper limit of normal (ULN)
13. Acceptable renal function:
14. Acceptable hematologic status (without hematologic support):
* ANC ≥1500 cells/uL
* Platelet count ≥100,000/uL
* Hemoglobin ≥9.0 g/dL
15. All women of childbearing potential must have a negative serum pregnancy test and male and female subjects must agree to use effective means of contraception (surgical sterilization or the use or barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) with their partner from entry into the study through 6 months after the last dose.
16. Availability of biological material for central review and biomarker evaluation.
17. Untreated recurrent or residual disease that is measurable by RANO criteria at time of enrollment. Multifocal and infratentorial disease is allowed.
18. Positive Trop-2 expression (H-Score ≥200), as verified by central review at University of Texas Health Science Center at San Antonio (UTHSA).

1. Prior treatment with bevacizumab or other VEGF inhibitors or VEGF-Receptor signaling inhibitors
2. 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.
4. The subject is unable to undergo MRI scan (eg, has pacemaker). 5. The subject has received enzyme-inducing anti-epileptic agents within 14 days of study drug (eg, carbamazepine, phenytoin, phenobarbital, primidone).
6. The subject is pregnant or breast-feeding. 7. The subject has serious intercurrent illness, such as:
* 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 drug
* 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.

Contacts and Locations

Study Contact

Epp Goodwin

CONTACT

210-450-1000

goodwine@uthscsa.edu

Principal Investigator

William Kelly, MD

PRINCIPAL_INVESTIGATOR

Mays Cancer Center, UT Health San Antonio

Study Locations (Sites)

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44106

United States

Texas Oncology Austin

Austin, Texas, 78705

United States

University of Texas Health Science Center San Antonio at the Cancer Therapy and Research Center

San Antonio, Texas, 78229

United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center at San Antonio

William Kelly, MD, PRINCIPAL_INVESTIGATOR, Mays Cancer Center, UT Health San Antonio

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-06

Study Completion Date2026-08

Study Record Updates

Study Start Date2022-01-06

Study Completion Date2026-08

Terms related to this study

Keywords Provided by Researchers

Trophoblast Cell-Surface Antigen 2
Trop-2
Sacituzumab Govitecan

Additional Relevant MeSH Terms

Recurrent Glioblastoma