Phase I/II Randomized Study of NBTXR3 Activated by Abscopal or RadScopal Radiation in Combination With Immunotherapy (Anti-PD-1/L-1) for Patients With Advanced Solid Malignancies
M.D. Anderson Cancer Center
Summary
This phase I/II trial studies the side effects and possible benefits of NBTXR3, radiation therapy, Anti PD-1 / PD-L1 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 Anti PD-1 / PD-L1 monoclonal antibodies, such as 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, Anti PD-1 / PD-L1 may help to control the disease.
Description
Primary Objective Phase I \& II • To evaluate efficacy and safety of NBTXR3 activated by radiation (Abscopal or RadScopal™) in combination with immunotherapy ( anti-PD-1/L-1) Secondary Objective: * To evaluate the safety profile of NBTXR3 activated by radiation (Abscopal or RadScopal™) in combination with immunotherapy ( anti-PD-1/L-1). * To evaluate time-to-event outcomes of NBTXR3 activated by radiation (Abscopal or RadScopal™) in combination with immunotherapy ( anti-PD-1/L-1). Exploratory Objectives: I. To evaluate radiomic measurements with outcomes of study treatments. II. To eval…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patients with metastatic disease in the lung and/or liver, or soft tissue from any primary malignancy considered incurable by local therapies. a. One prior anti-PD-1/L1 therapy allowed. 2. The target lesion(s) must be measurable as per irRECIST and repeated measurements at the same anatomical location should be achievable. a. Participant must have at least 2 measurable lesions at screening. i. Abscopal cohort: At least one lesion will receive NBTXR3 and high dose radiation (high dose target lesion). The other lesion(s) (non-treated target lesion) will be followe…
Interventions
- OtherHafnium Oxide-containing Nanoparticles NBTXR3
Given intratumorally
- RadiationRadiation Therapy
Undergo Abscopal radiation therapy
- RadiationRadiation Therapy
Undergo RadScopal radiation therapy
Location
- M D Anderson Cancer CenterHouston, Texas