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Study identifier: NCT07225036 Synced from ClinicalTrials.gov · August 08, 2026
● Study status: RecruitingPRIME-LRT

Promoting Immunotherapy Efficacy With Low-Dose Liver RT

Condition: Low-Dose Liver Radiation (LD-LRT) · Non Small Cell Lung Cancer · Melanoma  ·  Sponsor: Jordan Kharofa

PhaseNA
Planned participants21
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNoCheck eligibility criteria ↓
WhereCincinnati, Ohio, United States

Interested? Contact the study team ↓

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

UCCC Clinical Trials Office  ·  513-584-7698  ·  cancer@uchealth.com

Jordan Kharofa, MD

There is no obligation to join — the study team can answer your questions about taking part.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

Inclusion Criteria: 1. Age ≥18 years. 2. ECOG performance status ≤2 (or Karnofsky ≥60%, see Appendix A). 3. Patients must have adequate organ and marrow function to receive standard of care immunotherapy and/or chemoimmunotherapy as per the treating medical oncologist. 4. 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. 5. Biopsy proven Non-Small Cell Lung Cancer (NSCLC) or Melanoma. 6. Radiographic evidence of liver metastases. 7. 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. 8. 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. 9. Patients must have insurance authorization to proceed with radiotherapy prior to initiation of radiation treatment on study Exclusion Criteria: 1. 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. 2. Patients with NSCLC are ineligible for enrollment in cohort 1 if the presence of the following driver mutations are noted: EGFR, ALK, ROS1, RET. 3. 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. 4. 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. 5. Pregnant women are excluded from this study considering the use of ionizing radiation.

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (1)

University of Cincinnati Medical CenterCincinnati, Ohio, United StatesRecruiting

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Cincinnati

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