Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04862455
Status:
RECRUITING
Last Update Posted:
2024-04-15
First Post:
2021-04-05
Brief Title:
NBTXR3 Radiation Therapy and Pembrolizumab for the Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Study of NBTXR3 Activated by Radiation and Combined With Pembrolizumab for Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma With Limited PD-L1 Expression or Refractory to PD-1 Blockade
Status:
RECRUITING
Status Verified Date:
2024-04
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 II trial investigates the effect of NBTXR3 radiation therapy and pembrolizumab in treating patients with head and neck squamous cancer that has come back recurrent or has spread to other places in the body metastatic NBTXR3 may cause cell destruction when activated by radiation Radiation therapy such as stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue And hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects Immunotherapy with monoclonal antibodies such as pembrolizumab may help the bodys immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread Giving NBTXR3 radiation therapy and pembrolizumab may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVE
I To evaluate tumor response of hafnium oxide-containing nanoparticles NBTXR3 NBTXR3 activated by radiation therapy RT in combination with pembrolizumab in patients with recurrentmetastatic RM head and neck squamous cell cancer HNSCC
SECONDARY OBJECTIVES
I To assess unacceptable treatment-related toxicity of NBTXR3 activated by RT in combination with pembrolizumab in patients with RM HNSCC
II To assess the safety profile of NBTXR3 activated RT in combination with pembrolizumab in patients with RM HNSCC
III To evaluate time-to-event outcomes of NBTXR3 activated by RT in combination with pembrolizumab in patients with RM HNSCC
EXPLORATORY OBJECTIVES
I To associate radiomic measurements with outcomes of treatment with NBTXR3 activated by RT in combination with pembrolizumab
II To evaluate biomarkers of response in subjects treated with NBTXR3 activated by RT in combination with pembrolizumab
OUTLINE
Patients receive hafnium oxide-containing nanoparticles NBTXR3 via injection intratumorally or intranodally on day 1 Beginning as early as day 3 and within 8 days of NBTXR3 injection patients undergo stereotactic body radiation therapy SBRT every other day QOD or hypofractionated RT once daily QD over 1-2 weeks at the discretion of the treating radiation oncologist Starting on the same day as radiation therapy patients also receive pembrolizumab intravenously IV over 30 minutes every 3 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 6 weeks for 2 years
I To evaluate tumor response of hafnium oxide-containing nanoparticles NBTXR3 NBTXR3 activated by radiation therapy RT in combination with pembrolizumab in patients with recurrentmetastatic RM head and neck squamous cell cancer HNSCC
SECONDARY OBJECTIVES
I To assess unacceptable treatment-related toxicity of NBTXR3 activated by RT in combination with pembrolizumab in patients with RM HNSCC
II To assess the safety profile of NBTXR3 activated RT in combination with pembrolizumab in patients with RM HNSCC
III To evaluate time-to-event outcomes of NBTXR3 activated by RT in combination with pembrolizumab in patients with RM HNSCC
EXPLORATORY OBJECTIVES
I To associate radiomic measurements with outcomes of treatment with NBTXR3 activated by RT in combination with pembrolizumab
II To evaluate biomarkers of response in subjects treated with NBTXR3 activated by RT in combination with pembrolizumab
OUTLINE
Patients receive hafnium oxide-containing nanoparticles NBTXR3 via injection intratumorally or intranodally on day 1 Beginning as early as day 3 and within 8 days of NBTXR3 injection patients undergo stereotactic body radiation therapy SBRT every other day QOD or hypofractionated RT once daily QD over 1-2 weeks at the discretion of the treating radiation oncologist Starting on the same day as radiation therapy patients also receive pembrolizumab intravenously IV over 30 minutes every 3 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 6 weeks for 2 years
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-0541 | OTHER | M D Anderson Cancer Center | None |
| NCI-2021-00122 | REGISTRY | None | None |