Stereotactic Body Radiation Therapy for Head and Neck Squamous Cell Carcinoma (HNSCC)

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Head and Neck Squamous Cell Carcinoma (HNSCC)+1 MoreStereotactic Body Radiation Therapy - Radiation
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a combination of NBTXR3, radiation therapy, and pembrolizumab to treat patients with head and neck squamous cancer that has come back or spread to other parts of the body. NBTXR3 may make tumors more sensitive to radiation therapy. Radiation therapy, such as stereotactic body radiation therapy, uses special equipment to focus high doses of radiation on tumors with fewer doses over a shorter period, which may kill more tumor cells with less damage to normal tissue. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack

Eligible Conditions
  • Head and Neck Squamous Cell Carcinoma (HNSCC)
  • Head and Neck Squamous Cell Carcinoma

Treatment Effectiveness

Study Objectives

5 Primary · 3 Secondary · Reporting Duration: Time from NBTXR3 injection to death from any cause, assessed up to 2 years

Year 2
Overall survival
Year 2
Progression free survival
Up to 2 years
Adrenal gland hypofunction
Duration of response
Local anesthesia
Objective response rate
Regional failure
Treatment related acute and late onset toxicities

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

Treatment (NBTXR3, RT, pembrolizumab)
1 of 1

Experimental Treatment

60 Total Participants · 1 Treatment Group

Primary Treatment: Stereotactic Body Radiation Therapy · No Placebo Group · Phase 2

Treatment (NBTXR3, RT, pembrolizumab)Experimental Group · 4 Interventions: Hypofractionated Radiation Therapy, Stereotactic Body Radiation Therapy, Pembrolizumab, Hafnium Oxide-containing Nanoparticles NBTXR3 · Intervention Types: Radiation, Radiation, Biological, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hypofractionated Radiation Therapy
2016
Completed Phase 2
~20
Stereotactic Body Radiation Therapy
2019
Completed Phase 2
~600
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: time from nbtxr3 injection to death from any cause, assessed up to 2 years

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,802 Previous Clinical Trials
1,788,843 Total Patients Enrolled
Jay ReddyPrincipal InvestigatorM.D. Anderson Cancer Center

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have received prior anti-PD-1/L1 therapy.
You have received prior systemic therapy (i.e.
If HPV status previously tested using aforementioned method or an equivalent, no additional testing needed.
HPV testing by p16 IHC is not required for HPV testing of oral cavity, hypopharynx, and larynx cancer.