PRIME-LRT: PRomoting IMmunotherapy Efficacy With Low-Dose Liver RT
Jordan Kharofa
Summary
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.
Description
Patients will continue standard of care immunotherapy (with or without standard chemotherapy). The research aspect of this study will be adding in the Low-Dose Liver Radiation (LD-LRT) before cycles 1, 2, 3 of treatment to see if this improves the treatment effects. The trial will be conducted using Simon's optimal two-stage test in two separate cohorts. Cohort 1 will include patients with NSCLC with liver metastases. Cohort 2 will include patients with melanoma with liver metastases. The primary endpoint is 6-month PFS for each cohort compared separately to historical trials with an effect s…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- RadiationLD-LRT
Low-dose radiation to the liver the week prior to Cycles 1, 2 and 3 of standard of care immunotherapy treatment.
Location
- University of Cincinnati Medical CenterCincinnati, Ohio