Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2026-01-01 @ 11:07 PM
Study NCT ID:
NCT05039632
Status:
RECRUITING
Last Update Posted:
2025-11-06
First Post:
2021-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief 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
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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 evaluate biomarkers of response in subjects after receiving study treatment.
OUTLINE: Patients are randomized to 1 of 2 cohorts.
COHORT I: Patients receive NBTXR3 intratumorally on day 1. Patients also receive ( anti-PD-1/L-1) intravenously (IV) on day 8. Beginning day 15, patients undergo Abscopal radiation therapy over 1-2 weeks. Cycles with ( anti-PD-1/L-1) repeat every 3-6 weeks per standard of care up to 2 years in the absence of disease progression or unacceptable toxicity.
COHORT II: Patients receive NBTXR3 intratumorally on day 1. Patients also receive ( anti-PD-1/L-1) IV on day 8. Beginning day 15, patients undergo RadScopal radiation therapy over 1-2 weeks. Cycles with ( anti-PD-1/L-1)repeat every 3-6 weeks per standard of care up to 2 years in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 12 weeks for up to 2 years post-radiation therapy.
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 evaluate biomarkers of response in subjects after receiving study treatment.
OUTLINE: Patients are randomized to 1 of 2 cohorts.
COHORT I: Patients receive NBTXR3 intratumorally on day 1. Patients also receive ( anti-PD-1/L-1) intravenously (IV) on day 8. Beginning day 15, patients undergo Abscopal radiation therapy over 1-2 weeks. Cycles with ( anti-PD-1/L-1) repeat every 3-6 weeks per standard of care up to 2 years in the absence of disease progression or unacceptable toxicity.
COHORT II: Patients receive NBTXR3 intratumorally on day 1. Patients also receive ( anti-PD-1/L-1) IV on day 8. Beginning day 15, patients undergo RadScopal radiation therapy over 1-2 weeks. Cycles with ( anti-PD-1/L-1)repeat every 3-6 weeks per standard of care up to 2 years in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 12 weeks for up to 2 years post-radiation therapy.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: