Promoting Immunotherapy Efficacy With Low-Dose Liver RT
PRIME-LRT: PRomoting IMmunotherapy Efficacy With Low-Dose Liver RT
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether adding low-dose radiation to the liver helps people live longer without their cancer getting worse. It is for adults with melanoma or non-small cell lung cancer that has spread to the liver who will receive immunotherapy, a treatment that helps the immune system fight cancer.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You must be 18 or older.
- You must be able to do most self-care or need only some help with daily needs (ECOG score 0–2 or Karnofsky score at least 60%).
- Your organs and bone marrow, which makes blood cells, must work well enough for your planned cancer treatment.
- You must plan to and be able to receive standard PD-1 or PD-L1 immunotherapy during radiation treatment. Other standard cancer drugs may be used with it.
- A tissue test must confirm melanoma or non-small cell lung cancer, and scans must show cancer in the liver.
- Men and women who can become pregnant must agree to use birth control or avoid sex before joining and throughout the study.
- You must understand and agree to join by signing a consent form. A legally authorized person may give consent for you.
- Your insurance must approve radiation treatment before it starts.
Who can't join
- You had immunotherapy to help prevent melanoma or non-small cell lung cancer from returning within 6 months before joining.
- You have non-small cell lung cancer with an EGFR, ALK, ROS1, or RET gene change and are joining study group 1.
- You have an uncontrolled illness or another serious condition that the study doctor thinks would make joining too risky.
- You have a past or current other cancer whose course or treatment could affect how the study team judges treatment safety or results.
- You are pregnant, because this study uses radiation.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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.
Study sites (1)
OH
- University of Cincinnati Medical Center · Cincinnati, OH 45219UCCC CTO · Study contact · 513-584-7698 · cancer@uchealth.comJordan Kharofa, MD · Principal investigatorMore trials in Cincinnati