Promoting Immunotherapy Efficacy With Low-Dose Liver RT

Recruiting now · Not applicable

Conditions studied: Low-Dose Liver Radiation (LD-LRT), Non Small Cell Lung Cancer, Melanoma, Liver Metastases

In brief

The purpose of this study is to see if adding Low-Dose Liver Radiation (LD-LRT) improves progression free survival (PFS). This study is for patients with either melanoma or non-small cell lung cancer (NSCLC), with liver metastases, and receiving immunotherapy.

Key facts

Study ID

NCT07225036

Run by

Jordan Kharofa

People needed

21

Starts

2025-12-15

Expected to finish

2029-12-15

Last updated by the study team

2026-02-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥18 years.
• ECOG performance status ≤2 (or Karnofsky ≥60%, see Appendix A).
• Patients must have adequate organ and marrow function to receive standard of care immunotherapy and/or chemoimmunotherapy as per the treating medical oncologist.
• Must be planning to, and able to, undergo active treatment with PD-L1 or PD-1 checkpoint immunotherapy given per standard care throughout the duration of the RT intervention per their treating physician.
• Note: Patients may receive other SOC CTLA 4 inhibitors or other SOC chemotherapy/immunotherapy in combination with a SOC PD-L1 or PD-1 checkpoint inhibitor and remain eligible.
• Biopsy proven Non-Small Cell Lung Cancer (NSCLC) or Melanoma.
• Radiographic evidence of liver metastases.
• Women of child-bearing potential and men must agree to use adequate contraception (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
• Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.
• Patients must have insurance authorization to proceed with radiotherapy prior to initiation of radiation treatment on study

You may not qualify if…

• Patients with prior immunotherapy use in the adjuvant setting for NSCLC or Melanoma are eligible unless the adjuvant immunotherapy was delivered within 6 months of enrollment.
• Patients with NSCLC are ineligible for enrollment in cohort 1 if the presence of the following driver mutations are noted: EGFR, ALK, ROS1, RET.
• Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous, in the opinion of the Investigator.
• Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen in the opinion of the Investigator.
• Pregnant women are excluded from this study considering the use of ionizing radiation.

Where it is running

• University of Cincinnati Medical Center — Cincinnati, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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