Skip to content
TrialMatch
Sign up
Recruiting

Promoting Immunotherapy Efficacy With Low-Dose Liver RT

Create a profile to match View the full record on ClinicalTrials.gov

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.

Condition
Low-Dose Liver Radiation (LD-LRT), Non Small Cell Lung Cancer, Melanoma, Liver Metastases
Tested
LD-LRT
Sponsor
Jordan Kharofa

Who can join

Age
18 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 12

  • Minimum age: 18 years
  • Study condition: Low-Dose Liver Radiation (LD-LRT), Non Small Cell Lung Cancer, Melanoma, Liver Metastases
  • 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 5

  • 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

1 site, 1 recruiting

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.