NCT06416436

Dose-escalation Study of Ultra-high Dose Ablative Radiosurgery With Immunotherapy for Bulky Metastatic Cancer Patients

Immunotherapy in Combination With Ablative Radiosurgery to Ultra-high DoSes (ICARUS): A Phase I Dose-escalation Radiosurgery Study in Metastatic Cancers

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	Atezolizumab	Atezolizumab will be administered at a fixed dose of 1680 mg IV route every 4 weeks (1680 mg on Day 1 of each 28-day cycle), which is an approved dosage for atezolizumab, as outlined in the prescribing information.
RADIATION	Stereotactic Ablative Radiotherapy (SBRT)	Ultra-High Doses of Ablative Radiosurgery SBRT is delivered to metastases over 3-5 fractions within 1-2 weeks

Timeline

• Start date: 2024-07-15
• Primary completion: 2024-07-15
• Completion: 2024-07-15
• First posted: 2024-05-16
• Last updated: 2025-06-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study