Promoting Immunotherapy Efficacy With Low-Dose Liver RT
NCT ID: NCT07225036
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
21 participants
INTERVENTIONAL
2025-12-15
2029-12-15
Brief Summary
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Detailed Description
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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 size goal of 25% improvement in 6-month PFS.
Cohort 1 NSCLC- The estimated 6-month PFS in NSCLC with liver metastasis was obtained from a metanalysis of 8 randomized trials evaluating the effect of liver metastases in patients treated with PD-1/PD-L1 inhibitors and chemotherapy (SOC) or chemotherapy alone\[30\]. Based on the pooled hazard ratios we estimate a 0.68 HR and PFS of 30% at 6 months with chemotherapy alone. Assuming underlining exponential distribution for survival time, we estimate the 6-month PFS is 44% in patients with liver metastases treated with PD-1/PD-L1 inhibitors and chemotherapy.
Simon's optimal two-stage design (Simon, 1989) will be used for conducting the trial. In cohort 1, the null hypothesis is that the true response rate (6-month PFS) is 0.44, and the alternative hypothesis is that the true response rate is 0.69. The trial is carried out in two stages. In stage I, a total number of 11 patients is accrued. If there are 5 or fewer responses among these 11 patients, cohort 1 will be stopped. Otherwise, an additional 15 patients will be accrued in stage II, resulting in a total number sample size of 26. If there are 16 or more responses among these 26 patients, we reject the null hypothesis and claim that the treatment is promising. The design controls the type I error rate at 0.049 and yields the power of 0.81. The probability of early termination is 66%.
Cohort 2 Melanoma with liver met (Expected 6-mo PFS= 30%, Desired 6-mo PFS=55%) The null hypothesis for 6-month PFS of 30%, based on historic clinical trials and series specifically evaluating PFS in patients with melanoma and liver metastases treated with standard of care immunotherapy\[9-11, 14\]. The alternative hypothesis is that the 6-month PFS is 55%. The trial is carried out in two stages. In stage I, a total number of 10 patients is accrued. If there are 3 or fewer responses among these 10 patients, the cohort will be closed. Otherwise, an additional 18 patients will be accrued in stage II for cohort 2, resulting in a total sample size of 28 patients. If there are 13 or more responses among these 28 patients, we reject the null hypothesis and claim that the treatment is promising. The design controls the type I error rate at 0.05 and yields the power of 0.8. The probability of early termination is 65%.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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LD-LRT
Low-dose radiation to the liver the week prior to Cycles 1, 2 and 3 of systemic treatment.
LD-LRT
Low-dose radiation to the liver the week prior to Cycles 1, 2 and 3 of standard of care immunotherapy treatment.
Interventions
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LD-LRT
Low-dose radiation to the liver the week prior to Cycles 1, 2 and 3 of standard of care immunotherapy treatment.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Jordan Kharofa
OTHER
Responsible Party
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Jordan Kharofa
Principal Investigator
Locations
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University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Countries
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Central Contacts
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Jordan Kharofa, MD
Role: CONTACT
Facility Contacts
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UCCC CTO
Role: primary
Other Identifiers
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UCCC-RT-25-01
Identifier Type: -
Identifier Source: org_study_id