Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07770100
PHASE2

Concurrent Immunotherapy and Systemic Therapy With Stereotactic Body Radiation Therapy (SBRT) for Stage IV Cancers (COINSSS IV)

Sponsor: Mark Bernard

View on ClinicalTrials.gov

Summary

This phase II, single arm study evaluates the feasibility and clinical outcomes of delivering stereotactic body radiation therapy (SBRT) to 6-10 metastatic lesions concurrently with standard-of-care immune checkpoint inhibitor therapy in patients with stage IV cancers, including head and neck, non-small cell lung cancers, cervical, esophageal, gastric and gastroesophageal cancers. The primary objective is to determine 6-month progression-free survival following concurrent treatment. Secondary objectives include assessment of toxicity, overall survival, local recurrence-free survival, distant metastasis progressive free survival, response rates, and continuation of systemic therapy.

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

35

Start Date

2026-10-01

Completion Date

2040-02-28

Last Updated

2026-08-18

Healthy Volunteers

No

Interventions

RADIATION

Stereotactic Body Radiation Therapy (SBRT)

SBRT administered to 6-10 metastatic lesions during the first cycle of immunotherapy.

DRUG

Pembrolizumab

FDA-approved immune checkpoint inhibitor administered according to standard clinical practice and disease-specific indications.

DRUG

Nivolumab

FDA-approved immune checkpoint inhibitor administered according to standard clinical practice and disease-specific indications.

DRUG

Atezolizumab

FDA-approved immune checkpoint inhibitor administered according to clinical practice and disease-specific indications.

DRUG

Ipilimumab

FDA-approved immune checkpoint inhibitor administered according to standard clinical practice and disease-specific indications.

Locations (1)

University of Kentucky Markey Cancer Center

Lexington, Kentucky, United States