Neoplasms

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Neoplasm Metastasis

Neoplastic Processes

Antineoplastic Agents

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Atezolizumab

Immunomodulating Agents

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

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.

Ultra-High Doses of Ablative Radiosurgery

SBRT is delivered to metastases over 3-5 fractions within 1-2 weeks

Stereotactic Ablative Radiotherapy (SBRT)

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Maggie Thomas

Gregory Gan, MD

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.

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.

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

Maximum tolerated dose of ultra-high dose SBRT for 3 different body sites (i.e., peripheral lung, mediastinum-central lung, and abdomen-pelvis)

To assess the safety of ultra-high dose SBRT with concurrent and adjuvant atezolizumab in participants with cancer who have exhausted standard of care treatment options

To assess the overall tumor response rate of participants receiving ultra-high dose SBRT with concurrent and adjuvant atezolizumab

To assess the progression-free survival of participants receiving ultra-high dose SBRT with concurrent and adjuvant atezolizumab in participants with cancer who have exhausted standard of care treatment options.

To assess the overall survival of participants receiving ultra-high dose SBRT with concurrent and adjuvant atezolizumab in participants with cancer who have exhausted standard of care treatment options

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Dose-escalation Study of Ultra-high Dose Ablative Radiosurgery With Immunotherapy for Bulky Metastatic Cancer Patients	NCT06416436	Solid Tumor	Atezolizumab Stereotactic Ab...	18 Years -	University of Kansas Medical Center
Dose-escalation Study of Ultra-high Dose Ablative Radiosurgery With Immunotherapy for Bulky Metastatic Cancer Patients	NCT06416436	Solid Tumor	Atezolizumab Stereotactic Ab...	18 Years -	University of Kansas Medical Center

Spots Global Cancer Trial Database for stereotactic ablative radiotherapy (sbrt)