Exploratory Study of PD-1 Neoadjuvant Treatment of Recurrent Meningioma
1 other identifier
interventional
15
1 country
1
Brief Summary
This research study is studying a drug as a possible treatment for High Grade Meningioma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2020
CompletedFirst Submitted
Initial submission to the registry
January 25, 2021
CompletedFirst Posted
Study publicly available on registry
January 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2025
CompletedAugust 10, 2021
August 1, 2021
3 years
January 25, 2021
August 9, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival
Contrast-enhanced cranial MRI will be performed every 6 weeks. PFS6 is defined as not having progressive disease or death within six months of the first day of treatment. Contrast-enhanced cranial magnetic resonance imaging (MRI) will be performed every 6 weeks.
Every 6 weeks, up to 6 months
Secondary Outcomes (1)
Overall Survival
6 months and 12 months
Study Arms (1)
Sintilimab
EXPERIMENTALSintilimab will be administered every 3 weeks Sintilimab will be administered through IV infusion
Interventions
Sintilimab binds to PD-1, an inhibitory signaling receptor expressed on the surface of activated T cells, and blocks the binding to and activation of PD-1 by its ligands, which results in the activation of T-cell-mediated immune responses against tumor cells
Eligibility Criteria
You may qualify if:
- Pathologically diagnosed as a patient with WHO grade III recurrent meningioma
- Age ≥ 18 years
- Kps≥70
- able to accept second surgery
- ECOG Performance Status \< 2
- Glucocorticoid dosage dexamethasone ≤5mg/ day or equivalent dose
You may not qualify if:
- Participants who have had chemotherapy, targeted small molecule therapy or study therapy within 14 days of protocol treatment, or those who have not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 2 weeks earlier.
- Participants who are receiving any other investigational agents.
- Participants who have a diagnosis of an immunodeficiency.
- Requires treatment with high dose systemic corticosteroids defined as dexamethasone \>2mg/day or bioequivalent within 7 days of initiating therapy.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent. Unable to undergo brain MRI.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing TianTan Hospital
Beijing, Beijing Municipality, 100071, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Feng Chen
Beijing Tiantan Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2021
First Posted
January 28, 2021
Study Start
June 1, 2020
Primary Completion
June 1, 2023
Study Completion
June 1, 2025
Last Updated
August 10, 2021
Record last verified: 2021-08