Actively Recruiting
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
Led by M.D. Anderson Cancer Center · Updated on 2026-02-06
40
Participants Needed
1
Research Sites
247 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with metastatic disease in the lung and/or liver, or soft tissue from any primary malignancy considered incurable by local therapies.
- One prior anti-PD-1/L1 therapy allowed.
- Target lesions must be measurable per irRECIST with at least 2 measurable lesions at screening.
- For Abscopal cohort: at least one lesion receives NBTXR3 and high dose radiation; other lesions are monitored without treatment.
- For RadScopal cohort: at least one lesion receives NBTXR3 and high dose radiation; other lesions receive low dose radiation.
- Patients must be able to undergo image guided intratumoral injection of NBTXR3 in up to two high dose target lesions in lung or liver.
- Selected lesions must be suitable for radiation therapy as determined by investigator.
- Allowed high dose radiation regimens: 50 Gy in 4 fractions or 60 Gy in 10 fractions.
- Allowed low dose radiation for RadScopal cohort: 1.4 Gy per fraction for 4-5 fractions.
- Radiation therapy for symptomatic metastatic disease prior to enrollment or during study is allowed.
- Age 18 years or older.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
- Laboratory values at screening: Hemoglobin ≥ 9.0 g/dL, Absolute Neutrophil Count ≥ 1,500/mm3, Platelet count ≥ 100,000/mm3, Leukocytes ≥ 1500/mm3, Creatinine ≤ 1.5 x upper limit of normal, Creatinine clearance > 30 mL/min, Total bilirubin ≤ 2.0 mg/dL, AST/ALT ≤ 2.0 x upper limit or ≤ 3 x upper limit for liver metastases.
- For lung metastases: adequate lung function with FEV1 ≥ 0.8L or ≥ 35% predicted and DLCO ≥ 40% within 30 days prior to NBTXR3 injection.
- Patients needing acute supplemental oxygen started within 7 ± 3 days due to tumor obstruction/hypoxia are eligible if oxygen amount is stable.
- Negative urine or serum pregnancy test within 7 days prior to NBTXR3 injection for women of child-bearing potential.
- Women of child-bearing potential must agree to contraception during study and for ~5.33 months after last dose of immunotherapy.
- Signed informed consent form indicating understanding and willingness to participate.
You will not qualify if you...
- Prior radiation therapy to selected high dose target lesion(s); prior radiation to low dose lesions allowed at investigator discretion.
- Symptomatic central nervous system metastases or carcinomatous meningitis.
- Previously treated brain metastases must be stable without progression for at least 4 weeks and no steroid treatment for at least 14 days prior to NBTXR3 injection.
- History of interstitial lung disease or unresolved organizing pneumonia.
- Any Grade 4 radiation toxicity.
- Unresolved radiation or immune checkpoint inhibitor related pneumonitis, bronchopulmonary hemorrhage, abdominal hemorrhage, or gastrointestinal events including diverticulitis, colitis, abscess, obstructions, carcinomatosis, or bowel perforation risk.
- Severe (Grade ≥ 3) immune-related adverse events or sensitivity to immunotherapy excipients.
- Use of any approved or investigational anti-cancer or immunotherapy agents within 2 weeks prior to NBTXR3 injection except anti-PD-1/L1.
- Active autoimmune disease requiring systemic treatment in past 2 years, except for certain replacement therapies.
- Live-virus vaccine within 4 weeks prior to NBTXR3 injection except killed-virus influenza vaccine.
- Prior allogenic stem cell or organ transplant.
- Uncontrolled illnesses such as active infections, congestive heart failure, unstable angina, renal failure, arrhythmias, or psychiatric illness limiting compliance.
- Known active uncontrolled HIV or hepatitis B or C infections.
- Pregnant or breastfeeding women.
- Women of child-bearing potential and male partners unwilling or unable to use effective contraception during study and for specified periods after last immunotherapy dose.
- Any condition that may compromise participant well-being or interfere with study assessments as judged by investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
N
Nathan Comeaux
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here