Study on Combining Immunotherapy and Radiation Therapy for Stage IV Cancers

Sponsor: Mark Bernard

Sponsor score: 0

ClinicalTrials ID:NCT07770100

This clinical trial is exploring a new treatment approach for people with stage IV cancer, using a combination of focused radiation therapy and immunotherapy. The study aims to determine if this combination can be safely administered alongside standard cancer treatments to help control the disease.

Patient Parameters

Program Overview

This Phase II study is testing a new treatment method for people with stage IV cancer. It combines a type of focused radiation therapy called stereotactic body radiation therapy (SBRT) with immunotherapy. The goal is to see if this combination can be safely given while patients continue their regular cancer treatments and if it can help manage their cancer more effectively.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of advanced or stage IV cancer in areas like the head and neck, lungs, cervix, esophagus, stomach, or gastroesophageal junction, with at least 6 cancer sites eligible for focused radiation therapy (SBRT).
  • Eligible for immunotherapy based on FDA-approved guidelines.
  • If previously treated with chemotherapy or radiation, it must have been completed more than 21 days before starting the study treatment.
  • Currently on first-line immunotherapy-based treatments.
  • Meet specific criteria for certain cancers, such as PD-L1 testing scores for lung, cervical, gastric, esophageal, or gastroesophageal cancers.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Life expectancy of at least 6 months.
  • Adequate organ and bone marrow function as determined by specific lab tests.
  • No other active cancers, except for certain skin cancers or cervical cancer that have been treated and disease-free for 3 years.
  • Women must not be pregnant or nursing and must agree to use effective contraception during the study.
  • Ability to understand and willingness to sign informed consent.

Exclusion Criteria

  • Have fewer than 6 cancer sites eligible for SBRT.
  • Ineligible for immune checkpoint inhibitors based on specific guidelines.
  • More than 7 cancer sites in a single organ.
  • Certain conditions like liver cirrhosis that prevent SBRT to the liver.
  • Recent major surgery or significant injury within 14 days before joining the study.
  • Active serious infections or non-healing wounds.
  • Uncontrolled health issues like heart failure, recent heart attacks, or high blood pressure.
  • Known infections like HIV or chronic hepatitis B or C.
  • Recent receipt of live vaccines within 30 days before starting the study treatment.
  • Women and minorities are encouraged to participate, consistent with NIH policy.

Locations

FACILITYZIPCITYSTATE
University of Kentucky Markey Cancer Center40536LexingtonKentucky

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