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 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 Dates

First listed: Aug 18, 2026
Start date: Oct 1, 2026
Status verified: Jun 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.