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PD-1 Inhibitor
NBTXR3 + Radiation + Pembrolizumab for Head and Neck Cancer
Phase 2
Recruiting
Led By Jay Reddy
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For patients with lung metastases, adequate lung function with expiratory volume in 1 second (FEV1) >= 0.8 L or >= 35% predicted and carbon monoxide diffusing capability (DLCO) >= 40% with or without bronchodilator within 28 days prior to NBTXR3 injection
Have provided tissue for PD-L1 biomarker analysis from a core or excisional biopsy, fine needle aspirate (FNA) not adequate
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from nbtxr3 injection to death from any cause, assessed up to 2 years
Awards & highlights
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
Who is the study for?
Adults with recurrent or metastatic head and neck squamous cell cancer, who can undergo specific radiation therapy and have at least two measurable lesions. They must be in good enough health for the trial, not pregnant, willing to use contraception, and have stable oxygen needs if they require supplemental oxygen.Check my eligibility
What is being tested?
The trial is testing a combination of NBTXR3 nanoparticles with high-precision radiation therapy and pembrolizumab (an immunotherapy drug) to see if this trio is more effective in treating head and neck cancer that has returned or spread.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system affecting organs, infusion-related reactions from pembrolizumab, tissue damage from radiation therapy, as well as general fatigue and potential blood disorders.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung function is good enough for treatment, based on recent tests.
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I have provided a tissue sample for PD-L1 testing that was not from a fine needle aspirate.
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My liver enzymes are within the required range.
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I am 18 years old or older.
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My oropharyngeal cancer is HPV positive, confirmed by a specific test.
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I am able to care for myself and perform daily activities.
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My cancer is in my head, neck, lung, or liver.
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My head or neck cancer cannot be cured with surgery or radiation.
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I have a cancer lesion in my head, neck, lung, or liver that will be treated with NBTXR3 and radiation.
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I have not been treated with PD-1/L1 inhibitors and my cancer's CPS is between 1% and 20%.
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My cancer did not respond to previous PD-1/L1 treatments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time from nbtxr3 injection to death from any cause, assessed up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from nbtxr3 injection to death from any cause, assessed up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adrenal gland hypofunction
Local anesthesia
Objective response rate
+2 moreSecondary outcome measures
Duration of response
Overall survival
Treatment related acute and late onset toxicities
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (NBTXR3, RT, pembrolizumab)Experimental Treatment4 Interventions
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 SBRT QOD or hypofractionated RT 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 IV over 30 minutes every 3 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hypofractionated Radiation Therapy
2016
Completed Phase 2
~130
Pembrolizumab
FDA approved
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~780
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,789,261 Total Patients Enrolled
Jay ReddyPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I still have side effects from cancer treatment that are not mild.My lung function is good enough for treatment, based on recent tests.I do not have an active, uncontrolled HIV or hepatitis B/C infection.I have provided a tissue sample for PD-L1 testing that was not from a fine needle aspirate.I haven't taken cancer drugs or immunotherapy in the last 4 weeks.My cancer can be treated with specific radiation therapy as decided by my doctor.I do not have any severe illnesses that could interfere with the treatment.I had skin, bladder, cervical, breast cancer, or prostate cancer but have been disease-free for 2+ years.My liver enzymes are within the required range.My cancer in the oral cavity, hypopharynx, or larynx is assumed to be HPV negative.I have had radiation therapy on my lung or liver.I can start the trial without waiting if I've had anti-PD-1 therapy and am in cohort 2.I am not pregnant and agree to use birth control during and 6 months after the study.My brain metastases are stable, and I haven't needed steroids for 2 weeks.I have an autoimmune disease treated with strong medication in the last 2 years.I haven't had any live-virus vaccines in the last 4 weeks.I am on replacement therapy like thyroxine, insulin, or low-dose corticosteroids.I have a cancer lesion that will not be treated but monitored.I can have up to 3 cancer spots treated with a special injection.I am 18 years old or older.My oropharyngeal cancer is HPV positive, confirmed by a specific test.I am able to care for myself and perform daily activities.I have had anti-PD-1/L1 therapy and my condition did not improve.I have a recent biopsy or an older one that can be used.My head or neck cancer is small enough for injection and radiation.My cancer is in my head, neck, lung, or liver.I had radiation for advanced disease in my head or neck less than 6 months ago.I have hair loss or mild to moderate nerve pain.I have no history of severe lung issues, unresolved pneumonia, major bleeding, or serious GI problems.I've had chemotherapy or targeted therapy for my advanced local disease.My condition is not head and neck cancer and can be treated with the aim of curing it.I've had severe reactions to previous immunotherapy or am highly sensitive to its ingredients.I am not pregnant or breastfeeding.My head or neck cancer cannot be cured with surgery or radiation.I have a cancer lesion in my head, neck, lung, or liver that will be treated with NBTXR3 and radiation.I have not been treated with PD-1/L1 inhibitors and my cancer's CPS is between 1% and 20%.My cancer did not respond to previous PD-1/L1 treatments.My lung or liver cancer can be treated with a specific injection and radiation therapy.My cancer can be measured and tracked using specific imaging techniques.I have had a stem cell transplant or an organ transplant.I may be eligible for shorter waiting periods between treatments if my medication has a short half-life.I have symptoms from cancer spread to my brain or its coverings.I have had cancer other than head and neck squamous cell carcinoma.I need extra oxygen due to my cancer, but the amount has been stable for about a week.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (NBTXR3, RT, pembrolizumab)
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are people with the qualifying condition able to enroll in this study at this time?
"The latest information available on clinicaltrials.gov suggests that this clinical trial is still recruiting patients. The original posting was on April 7th, 2021 with the 10/6/2022 update being the most recent."
Answered by AI
Has the FDA cleared Stereotactic Body Radiation Therapy for use?
"Although there is some data suggesting that Stereotactic Body Radiation Therapy may be safe, as this is only a Phase 2 trial, more research needs to be done to support its efficacy."
Answered by AI
What types of cancer does Stereotactic Body Radiation Therapy help to treat?
"Stereotactic Body Radiation Therapy is a common treatment for malignant neoplasms. It is also sometimes used to treat other conditions, such as unresectable melanoma or microsatellite instability high."
Answered by AI
How many research subjects are included in this investigation?
"current, the medical study is looking for 60 individuals from 1 site. This particular trial was first announced on 4/7/2021 with the latest update being 10/6/2022 according to clinicaltrials.gov"
Answered by AI
What other research projects have included Stereotactic Body Radiation Therapy as a variable?
"Currently, there are 1000 ongoing clinical trials for Stereotactic Body Radiation Therapy with 122 of them being in Phase 3. Many of the studies will soon be completed as they have already recruited all the patients needed. However, there are 36034 locations across where these kinds of trials are taking place."
Answered by AI
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