Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06416436
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-03
Brief Title:
Dose-escalation Study of Ultra-high Dose Ablative Radiosurgery With Immunotherapy for Bulky Metastatic Cancer Patients
Sponsor:
University of Kansas Medical Center
Organization:
University of Kansas Medical Center
Study Overview
Official Title:
Immunotherapy in Combination With Ablative Radiosurgery to Ultra-high DoSes ICARUS A Phase I Dose-escalation Radiosurgery Study in Metastatic Cancers
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether cytoreduction of bulky metastatic disease using ultra high dose SBRT in combination with immunotherapy is tolerable and feasible In patients who have exhausted SoC treatment options
Detailed Description:
Patients that provide informed consent will undergo a 30-day screening period to determine eligibility for the trial If eligible patients will begin treatment on SBRT delivered to metastases over 3-5 fractions within 1-2 weeks with concurrent and adjuvant atezolizumab 1680 mg on Day 1 of each 28-day cycle immunotherapy regimen for up to one year
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None