Avelumab With Radiotherapy in Patients With Leptomeningeal Disease
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|ClinicalTrials.gov Identifier: NCT03719768|
Recruitment Status : Recruiting
First Posted : October 25, 2018
Last Update Posted : November 16, 2021
|Condition or disease||Intervention/treatment||Phase|
|Leptomeningeal Metastases Leptomeningeal Disease||Drug: Avelumab Radiation: Whole Brain Radiotherapy||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase IB Study of Avelumab With Radiotherapy in Patients With Leptomeningeal Disease|
|Actual Study Start Date :||June 10, 2019|
|Estimated Primary Completion Date :||March 1, 2022|
|Estimated Study Completion Date :||March 1, 2023|
Experimental: Avelumab and Whole Brain Radiotherapy
Avelumab 800 mg intravenously (IV) and 3000 centriGray units (cGy) Whole Brain Radiotherapy once every 2 weeks
Patients will be given 800 mg Avelumab as a one hour intravenous infusion once every 2 weeks.
Other Name: Bavencio
Radiation: Whole Brain Radiotherapy
Patients will be given 3000 cGy Whole Brain Radiotherapy once every 2 weeks
Other Name: WBRT
- Safety and Dose Limiting Toxicity (DLT) measured by number of subjects with adverse events (AEs) [ Time Frame: End of treatment (3 months) ]
Adverse events will only include those that are determined to be related to study drug.
A DLT will be defined as any one of the following adverse events occurring within 28 days from first dose of Avelumab. Central Nervous System (CNS) toxicities: Any grade 3 or higher central nervous adverse events, including but not limited to cerebral hemorrhage and new-onset neurologic deficit. Non-CNS toxicities: Any grade 3 or higher nonhematologic AE with the exception of alopecia and fatigue - Grade > 3 nausea, vomiting, or diarrhea despite maximal medical therapy - Grade > 3 laboratory value if 1)medical intervention is required to treat the patient or 2) the abnormality leads to hospitalization • Any grade 3 or 4 event that does not improve within 6 weeks
- Number of T Cells [ Time Frame: Up to 11 months ]The number of T cells in the cerebrospinal fluid (CSF) and the CSF cytokine activation profile in the CSF (relative to serum) measured before and after Avelumab administration.
- Activation Status of T Cells [ Time Frame: Up to 11 months ]The activation status of T cells in the cerebrospinal fluid (CSF) and the CSF cytokine activation profile in the CSF (relative to serum) measured before and after Avelumab administration.
- Leptomeningeal Disease (LMDz)/CNS Response Rate and Systemic Response Rate [ Time Frame: Up to 11 months ]Any solid brain metastases associated with LMDz will be assessed with Response Assessment in Neuro-Oncology (RANO)-Brain Metastases (BM) criteria. Responses in the rest of the body will be measured using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
- Overall Survival (OS) Rate at 3 months [ Time Frame: 3 months ]OS, utilizing 95% confidence interval (95%CI).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03719768
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute||Recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Ali Drury-Sibiga 813-745-5689 Ali.Drury-Sibiga@moffitt.org|
|Principal Investigator: Peter Forsyth, MD|
|Sub-Investigator: Solmaz Sahebjam, MD|
|Sub-Investigator: Yolanda Pina, MD|
|Sub-Investigator: Nikhil Khushlani, MD|
|Sub-Investigator: Inna Smalley, PhD|
|Sub-Investigator: Kerian Smalley, PhD|
|Principal Investigator:||Peter A Forsyth, MD||H. Lee Moffitt Cancer Center and Research Institute|