RecruitingPhase 1Phase 2NCT05039632

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


Sponsor

M.D. Anderson Cancer Center

Enrollment

40 participants

Start Date

May 8, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new approach that combines a special radiation-enhancing nanoparticle (NBTXR3) injected directly into tumors, together with high-dose radiation and immunotherapy (a checkpoint inhibitor drug), to treat advanced cancer in the lungs, liver, or soft tissues. **You may be eligible if...** - You are 18 or older with metastatic cancer in the lungs, liver, or soft tissue that cannot be cured - You have at least 2 measurable tumors - Your tumors are accessible for direct injection - You are in reasonably good health (ECOG status 0–2) - You have adequate blood counts, kidney, and liver function - You have not had prior radiation to the target lesion **You may NOT be eligible if...** - You have cancer spread to the brain that is symptomatic - You have active autoimmune disease requiring systemic treatment - You have a history of severe immune-related side effects from prior immunotherapy - You have HIV, active hepatitis B or C - You had a prior organ or stem cell transplant - You are pregnant or breastfeeding - You had another cancer treatment within 2 weeks of planned injection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERHafnium Oxide-containing Nanoparticles NBTXR3

Given intratumorally

RADIATIONRadiation Therapy

Undergo Abscopal radiation therapy

RADIATIONRadiation Therapy

Undergo RadScopal radiation therapy


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT05039632


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