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RECRUITING
NCT07269080
PHASE1

STM-06: POLARIS-POlymetastic Lesion Ablative Radiotherapy With Immunotherapy Study

Sponsor: University of Illinois at Chicago

View on ClinicalTrials.gov

Summary

This is a non-randomized two-arm trial, specifically a pilot study in which patients with advanced solid tumor cancer with 3-10 metastatic lesions who are on immunotherapy will receive ablative RT to up to 10 lesions. After study intervention, participants will undergo ctDNA collection at 8 weeks after completion of ablative RT Post-treatment disease assessments, including imaging and serial ctDNA monitoring, as well as any additional treatments, will be at the discretion of the treating oncologist. Approximately 28 subjects (14 per cohort) will be enrolled. For subjects who do not complete the full planned course of RT for any reason, a final study visit should be performed approximately 30 days after the last fraction of radiation. If a subject is discontinued from the study with an ongoing adverse event or an unresolved clinically significant laboratory result, the clinical investigative team will attempt to provide follow-up until a satisfactory clinical resolution of the laboratory result or adverse event is achieved.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

28

Start Date

2025-12-08

Completion Date

2028-11

Last Updated

2026-03-02

Healthy Volunteers

No

Interventions

RADIATION

Ablative radiation treatment

Ablative radiation for all metastases should be completed within 3 weeks of the first dose of radiation. Metastases may be treated on an everyday or every other day schedule.

Locations (1)

University of Illinois at Chicago

Chicago, Illinois, United States