Promoting Immunotherapy Efficacy With Low-Dose Liver RT
Recruiting · NCT07225036 · Interventional (participants receive a specific treatment) · Lead sponsor: Jordan Kharofa
View the official record on ClinicalTrials.gov →Interventions studied
LD-LRT
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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
1 location listed across 1 US state.
- University of Cincinnati Medical Center - Cincinnati, Ohio, United States