NBTXR3, Radiation, and Immunotherapy for Advanced Solid Tumors
This study is looking at how safe and effective a combination treatment is for advanced solid tumors that have spread to the lung or liver. The treatment involves NBTXR3 (Hafnium Oxide-containing Nanoparticles) given directly into the tumor, along with radiation therapy and immunotherapy (Anti-PD-1/L-1, like nivolumab). NBTXR3 may help make tumor cells more sensitive to radiation, while immunotherapy aims to help your body's immune system fight the cancer. The study will measure side effects and how many patients respond to the treatment. You may be able to join if you have metastatic disease in the lung and/or liver, or soft tissue, from any primary cancer that cannot be cured by local treatments. You may have also received one prior anti-PD-1/L1 therapy. The study is currently enrolling about 40 participants.
- Study design
- This is a Phase I/II interventional study that will enroll about 40 participants. Participants will be randomly assigned to one of two groups to receive different types of radiation therapy.
- What's involved
- You would receive NBTXR3 directly into your tumor, followed by Anti-PD-1/L-1 intravenously, and then radiation therapy over 1-2 weeks. Immunotherapy cycles may repeat every 3-6 weeks for up to 2 years.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will track side effects for up to 4 weeks after radiation therapy and measure how well the treatment works for up to 12 weeks after radiation therapy.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
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
At a glance
Conditions
NCT05039632
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
M D Anderson Cancer Center
Houston, Texasstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Saumil Gandhi, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Incidence of dose limiting toxicitiesUp to 4 weeks post radiation therapy
Descriptive summary tables will be produced.
- Objective response rateUp to 12 weeks post radiation therapy
Defined as percentage of patients achieving complete or partial response, per immune-related Response Evaluation Criteria In Solid Tumors (irRECIST). The best overall response will be provided per irRECIST criteria and consideration of all imaging assessment is required.