Concurrent Immunotherapy and Systemic Therapy With Stereotactic Body Radiation Therapy (SBRT) for Stage IV Cancers (COINSSS IV)
NCT07770100 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35
Last updated 2026-08-20
Summary
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.
Conditions
- Head and Neck Cancer
- Non-Small Cell Lung Cancer
- Cervical Cancer
- Esophageal Cancer
- Gastric Cancer (GC)
Interventions
- RADIATION
-
Stereotactic Body Radiation Therapy (SBRT)
SBRT administered to 6-10 metastatic lesions during the first cycle of immunotherapy.
- DRUG
-
FDA-approved immune checkpoint inhibitor administered according to standard clinical practice and disease-specific indications.
- DRUG
-
FDA-approved immune checkpoint inhibitor administered according to standard clinical practice and disease-specific indications.
- DRUG
-
FDA-approved immune checkpoint inhibitor administered according to clinical practice and disease-specific indications.
- DRUG
-
FDA-approved immune checkpoint inhibitor administered according to standard clinical practice and disease-specific indications.
Sponsors & Collaborators
-
Mark Bernard
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-10-01
- Primary Completion
- 2040-02-28
- Completion
- 2040-02-28
- FDA Drug
- Yes
Countries
- United States
Study Locations
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