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New treatment option for Oligodendroglioma
Official title Sintilimab (One Anti-PD-1 Antibody) Plus Low-dose Bevacizumab for ctDNAlevel- Relapse and Clinical-relapse Oligodendroglioma
ClinicalTrials.gov ID: NCT05512351
What this study is testing
What is Tislelizumab plus Bevacizumab?
Tislelizumab plus Bevacizumab is an investigational medicine, being studied as a potential treatment for oligodendroglioma.
Also referred to as TYVYT®.
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 ongoing Phase 2, open-label, single-center, non-randomized study of sintilimab (one anti-PD-1 antibody same as nivolumab approved in China) plus bevacizumab administered in a low dosage schedule in adult (≥ 18 years) participants with a clinical relapse or circulating tumor DNA (ctDNA)-level relapse of Oligodendroglioma(WHO III). This study has three non-comparative study groups.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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
- Written informed consent and HIPAA authorization obtained from the subject/legal representative prior to performing any protocol-related procedures...
- people must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study...
- Histologically confirmed diagnosis of oligodendroglioma(WHO III)
- Resection surgery done at the study center (Henan Provincial People's Hospital), with an reservoir intraoperatively implanted connecting the surgical...
- An interval of \> 28 days and full recovery (i.e., no ongoing safety issues) from surgical resection prior to grouping
You likely can't join if
- More than two recurrences of oligodendroglioma
- Presence of extracranial metastatic, significant leptomeningeal disease or tumors primarily localized to the brainstem or spinal cord
- Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or...
- people with active, known or suspected autoimmune disease. people with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune...
- Previous radiation therapy with anything other than standard radiation therapy (i.e., focally directed radiation) administered as first line therapy
- Previous treatment with carmustine wafer except when administered as first line treatment and at least 6 months prior to randomization
See the full eligibility criteria
Who can join
- Written informed consent and HIPAA authorization obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations
- people must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study, including disease assessment by MRI and tumor in situ fluid (TISF) collection
- Histologically confirmed diagnosis of oligodendroglioma(WHO III)
- Resection surgery done at the study center (Henan Provincial People's Hospital), with an reservoir intraoperatively implanted connecting the surgical cavity and the subscalp for postoperative noninvasive TISF collection
- An interval of \> 28 days and full recovery (i.e., no ongoing safety issues) from surgical resection prior to grouping
- Karnofsky performance status (KPS) of 70 or higher
- Life expectancy \> 12 weeks
What rules you out
- More than two recurrences of oligodendroglioma
- Presence of extracranial metastatic, significant leptomeningeal disease or tumors primarily localized to the brainstem or spinal cord
- Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive...
- people with active, known or suspected autoimmune disease. people with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring...
- Previous radiation therapy with anything other than standard radiation therapy (i.e., focally directed radiation) administered as first line therapy
- Previous treatment with carmustine wafer except when administered as first line treatment and at least 6 months prior to randomization
- Previous bevacizumab or other VEGF or anti-angiogenic treatment
- Previous treatment with a PD-1, PD-L1 or CTLA-4 targeted therapy
- Evidence of \> Grade 1 CNS hemorrhage on the baseline MRI scan
- Inadequately controlled hypertension (defined as systolic blood pressure ≥160 mmHg and /or diastolic blood pressure ≥100 mmHg) within 7 days of first study treatment
- Prior history of hypertensive crisis, hypertensive encephalopathy, reversible posterior leukoencephalopathy syndrome (RPLS)
- Prior history of gastrointestinal diverticulitis, perforation, or abscess
- Clinically significant (i.e., active) cardiovascular disease, for example cerebrovascular accidents ≤ 6 months prior to study enrollment, myocardial infarction ≤ 6 months prior to study enrollment, unstable angina, New...
- Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months prior to start of study treatment. Any previous venous thromboembolism ≥ NCI CTCAE Grade 3...
- History of pulmonary hemorrhage/hemoptysis ≥ grade 2 (defined as ≥ 2.5 mL bright red blood per episode) within 1 month prior to randomization
- History or evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding (i.e., in the absence of therapeutic anticoagulation)
- Current or recent (within 10 days of study enrollment) use of anticoagulants that, in the opinion of the investigator, would place the subject at significant risk for bleeding. Prophylactic use of anticoagulants is...
- Surgical procedure (including open biopsy, surgical resection, wound revision, or any other major surgery involving entry into a body cavity) or significant traumatic injury within 28 days prior to first study...
- Minor surgical procedure (e.g., stereotactic biopsy within 7 days of first study treatment; placement of a vascular access device within 2 days of first study treatment)
- History of intracranial abscess within 6 months prior to randomization
- History of active gastrointestinal bleeding within 6 months prior to randomization
- Serious, non-healing wound, active ulcer, or untreated bone fracture
- people unable (due to existent medical condition, e.g., pacemaker or ICD device) or unwilling to have a head contrast enhanced MRI
- Positive test for hepatitis B virus surface antigen (HBV sAg) or detectable hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection
- Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
- History of severe hypersensitivity reaction to any monoclonal antibody
- Patients that require decadron \> 4 mg/ day or equivalent of steroids
The study team makes the final eligibility decision.
Where it's taking place
- Zhengzhou, Henan, China
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 Zhengzhou, Henan, China. 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.