Neoadjuvant Immunotherapy in Brain Metastases
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|ClinicalTrials.gov Identifier: NCT04434560|
Recruitment Status : Recruiting
First Posted : June 17, 2020
Last Update Posted : October 1, 2020
|Condition or disease||Intervention/treatment||Phase|
|Brain Metastases, Adult||Drug: Nivolumab Drug: Ipilimumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Phase II Trial of Surgery and Stereotactic Radiosurgery With and Without Neoadjuvant Nivolumab and Ipilimumab in Patients With Surgically-resectable, Solid Tumor Brain Metastases|
|Estimated Study Start Date :||September 2020|
|Estimated Primary Completion Date :||January 2023|
|Estimated Study Completion Date :||January 2023|
Experimental: Arm with checkpoint
Arm 1 (arm with checkpoint) 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
No Intervention: Arm without checkpoint
Arm 2 (control arm without checkpoint) will proceed straight to surgical resection with no nivolumab/ipilimumab given prior to surgery.
- Proportion of patients that receive neoadjuvant ipilimumab and nivolumab prior to surgery and SRS [ Time Frame: 10 days ]Proportion of patients within the neoadjuvant treatment arm (Arm 1) 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
|Contact: Sarah Sammons, MDemail@example.com|
|Contact: Stevie Threattfirstname.lastname@example.org|
|United States, North Carolina|
|Duke University Medical Center||Recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: Sarah Sammons, MD 919-668-5247 email@example.com|
|Contact: Stevie Threatt 919-684-5301 firstname.lastname@example.org|
|Principal Investigator: Sarah Sammons, MD|
|Principal Investigator:||Sarah Sammons, MD||Duke University|