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

Part of paid clinical trials in Lexington, Kentucky.

Sponsor: Mark Bernard
Study ID: NCT07770100
Phase: PHASE2
Status: Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex: ALL
Age: 18 Years - 99 Years
Healthy Volunteers: Not accepted

Interventions

Stereotactic Body Radiation Therapy (SBRT) — RADIATION
SBRT administered to 6-10 metastatic lesions during the first cycle of immunotherapy.
Pembrolizumab — DRUG
FDA-approved immune checkpoint inhibitor administered according to standard clinical practice and disease-specific indications.
Nivolumab — DRUG
FDA-approved immune checkpoint inhibitor administered according to standard clinical practice and disease-specific indications.
Atezolizumab — DRUG
FDA-approved immune checkpoint inhibitor administered according to clinical practice and disease-specific indications.
Ipilimumab — DRUG
FDA-approved immune checkpoint inhibitor administered according to standard clinical practice and disease-specific indications.

Study Details

This is a Phase II clinical study for people with stage IV cancer. The study will evaluate the use of stereotactic body radiation therapy (SBRT), a type of focused radiation treatment, together with immunotherapy-based treatment. SRBT will be used to treat multiple areas of cancer that have spread to other parts of the body. The study will evaluate whether this treatment approach can be safely given while patients continue their planned cancer treatment and may help control their cancer.

Key Dates

First listed: Aug 18, 2026
Start date: Oct 1, 2026
Status verified: Aug 2026
Primary completion: Feb 28, 2040
Completion: Feb 28, 2040

Study Design

Enrollment: 35 participants (estimated)
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Arms

Experimental: Concurrent Immunotherapy and SBRT
Participants receive standard-of-care immune checkpoint inhibitor therapy and concurrent stereotactic body radiation therapy (SBRT) to 6-10 metastatic lesions.