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Clinical Trial Summary

This phase I/II trial studies the side effects and possible benefits of NBTXR3, radiation therapy, ipilimumab, and nivolumab in treating patients with solid tumor that has spread to the lung (lung metastases) and/or liver (liver metastases). NBTXR3 may help make tumor cells more sensitive to the radiation therapy. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving NBTXR3, radiation therapy, ipilimumab, and nivolumab may help to control the disease.


Clinical Trial Description

PRIMARY OBJECTIVE: I. To evaluate the safety and efficacy of hafnium oxide-containing nanoparticles NBTXR3 (NBTXR3) activated by radiation (Abscopal or RadScopal) in combination with immunotherapy (anti-CTLA-4 & anti-PD-1). (Phase I & II) SECONDARY OBJECTIVES: I. To evaluate the safety profile of NBTXR3 activated by radiation (Abscopal or RadScopal) in combination with immunotherapy (anti-CTLA-4 & anti-PD-1). II. To evaluate time-to-event outcomes of NBTXR3 activated by radiation (Abscopal or RadScopal) in combination with immunotherapy (anti-CTLA-4 & anti-PD-1). EXPLORATORY OBJECTIVES: I. To evaluate radiomic measurements with outcomes of study treatments. II. To evaluate biomarkers of response in subjects after receiving study treatment. OUTLINE: Patients are randomized to 1 of 2 cohorts. COHORT I: Patients receive NBTXR3 intratumorally on day 1. Patients also receive ipilimumab intravenously (IV) over 90 minutes on day 8. Beginning day 15, patients undergo Abscopal radiation therapy over 1-2 weeks. Patients then receive ipilimumab IV over 90 minutes and nivolumab IV over 30 minutes on day 29. Cycles with nivolumab repeat every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. COHORT II: Patients receive NBTXR3 intratumorally on day 1. Patients also receive ipilimumab IV over 90 minutes on day 8. Beginning day 15, patients undergo RadScopal radiation therapy over 1-2 weeks. Patients then receive ipilimumab IV over 90 minutes and nivolumab IV over 30 minutes on day 29. Cycles with nivolumab repeat every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 8 weeks for up to 2 years post-radiation therapy. ;


Study Design


Related Conditions & MeSH terms

  • Advanced Malignant Solid Neoplasm
  • Metastatic Malignant Neoplasm in the Liver
  • Metastatic Malignant Neoplasm in the Lung
  • Metastatic Malignant Solid Neoplasm
  • Neoplasms
  • Neoplasms, Second Primary

NCT number NCT05039632
Study type Interventional
Source M.D. Anderson Cancer Center
Contact
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date September 11, 2021
Completion date February 1, 2026

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