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

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.

Eligibility

Age range

18–99 years

Sex

All

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.

Location