Neoadjuvant Immunotherapy in Brain Metastases
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|ClinicalTrials.gov Identifier: NCT04434560|
Recruitment Status : Terminated (Poor enrollment)
First Posted : June 17, 2020
Last Update Posted : September 20, 2021
|Condition or disease||Intervention/treatment||Phase|
|Brain Metastases, Adult||Drug: Nivolumab Drug: Ipilimumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Surgery and Stereotactic Radiosurgery With Neoadjuvant Nivolumab and Ipilimumab in Patients With Surgically-resectable, Solid Tumor Brain Metastases|
|Actual Study Start Date :||November 4, 2020|
|Actual Primary Completion Date :||June 17, 2021|
|Actual Study Completion Date :||June 17, 2021|
Experimental: Neoadjuvant Immunotherapy
Patients will receive a single dose of neoadjuvant nivolumab and ipilimumab 7 days (± 3 days) prior to surgical resection.
Nivolumab will be given at the FDA-approved dose of 3 mg/kg.
Other Name: Opdivo
Ipilimumab will be given at the FDA-approved dose of 1 mg/kg.
Other Name: Yervoy
- Proportion of patients that receive neoadjuvant ipilimumab and nivolumab prior to surgery and SRS [ Time Frame: 10 days ]Proportion of patients who have their surgery delayed by more than 4 days or surgery never occurs as a direct or indirect result of ipilimumab and nivolumab treatment.
- Proliferation of circulating T-cells [ Time Frame: 7 days ]Mean fold-change between baseline and day 1 in Ki67 levels.
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): NCT04434560
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Sarah Sammons, MD||Duke University|