Phase I/II Study of NBTXR3 with Radiation and Immunotherapy for Advanced Solid Tumors

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05039632

Provider View

This clinical trial is exploring the safety and potential benefits of using NBTXR3, a special treatment that makes cancer cells more sensitive to radiation, combined with radiation therapy and immunotherapy, for patients with advanced solid tumors that have spread to the lungs or liver.

Patient Parameters

Program Overview

The study aims to find out if NBTXR3, when used with radiation therapy and immunotherapy drugs like nivolumab, can help control advanced solid tumors that have spread to the lungs or liver. NBTXR3 is designed to make tumor cells more sensitive to radiation, which uses high-energy x-rays to kill cancer cells. Immunotherapy helps the immune system attack cancer cells and may prevent them from growing and spreading. The trial will assess the safety and effectiveness of this combination treatment.

Description

The main goal of this study is to evaluate how safe and effective NBTXR3 is when activated by radiation (Abscopal or RadScopal) and combined with immunotherapy (anti-PD-1/L-1). The study will also look at the safety profile and how long it takes for the treatment to show effects.

Patients will be randomly assigned to one of two groups:

  • Cohort I: Patients receive NBTXR3 directly into the tumor on day 1 and immunotherapy (anti-PD-1/L-1) through an IV on day 8. Starting on day 15, they undergo Abscopal radiation therapy for 1-2 weeks. The immunotherapy cycles repeat every 3-6 weeks for up to 2 years, unless the disease progresses or side effects become unacceptable.

  • Cohort II: Patients receive NBTXR3 directly into the tumor on day 1 and immunotherapy (anti-PD-1/L-1) through an IV on day 8. Starting on day 15, they undergo RadScopal radiation therapy for 1-2 weeks. The immunotherapy cycles repeat every 3-6 weeks for up to 2 years, unless the disease progresses or side effects become unacceptable.

After completing the study treatment, patients will have follow-up visits every 12 weeks for up to 2 years.

Eligibility Criteria

Inclusion Criteria

  • Have cancer that has spread to the lungs or liver and cannot be cured with local treatments.
  • Have previously received one anti-PD-1/L1 therapy.
  • Have at least two measurable tumors.
  • Be able to receive NBTXR3 injections directly into lung or liver tumors.
  • Be able to receive radiation therapy to selected tumors.
  • Be 18 years or older.
  • Have a good performance status (ECOG 0-2).
  • Meet specific blood and organ function criteria.
  • Have adequate lung function if there are lung metastases.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception during the study and for 160 days after the last treatment.
  • Provide signed informed consent to participate in the study.

Exclusion Criteria

  • Have had radiation therapy to the selected high dose target tumors.
  • Have untreated or symptomatic brain metastases.
  • Have a history of certain lung diseases or unresolved severe side effects from previous treatments.
  • Have had severe immune-related side effects from previous immunotherapy.
  • Have received other cancer treatments within 2 weeks before starting the study, except for anti-PD-1/L1.
  • Have an active autoimmune disease requiring treatment in the past 2 years.
  • Have received a live-virus vaccine within 4 weeks before starting the study.
  • Have had a stem cell transplant or organ transplant.
  • Have uncontrolled illnesses or infections.
  • Be pregnant or breastfeeding.
  • Be unwilling to use effective birth control during the study and for a specified time after the last treatment.
  • Have any condition that the investigator believes would not be in the participant's best interest.

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