Nanoparticle
NBTXR3 for Oral Squamous Cell Carcinoma
University of Chicago Medical Center, Chicago, IL
Targeting 12 different conditionsNBTXR3 +3 morePhase 1RecruitingResearch Sponsored by NanobiotixEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Life expectancy >12 weeks
Dose Escalation:
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up24 months
Awards & highlights
No Placebo-Only Group
Study Summary
This trial is testing a new cancer treatment that involves injecting a drug directly into tumors and combining it with anti-PD-1 therapy. The goal is to see if this is a safe and effective treatment for cancer.
Eligible Conditions
- Oral Squamous Cell Carcinoma
- Kidney Cancer
- Immunotherapy
- Radiotherapy
- Solid Malignant Tumor
- Liver Cancer
- Squamous Cell Carcinoma
- Cervical Cancer
- Skin Cancer
- Breast Cancer
- Non-Small Cell Lung Cancer
- Bladder Cancer
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You are expected to live for at least 12 more weeks.
Select...
The amount of medication given will gradually increase during the study.
Select...
You have a tumor in your head and neck area that cannot be removed with surgery or has come back after previous treatment, and it can be treated with radiation therapy again.
Select...
I'm sorry, but "Expansion" is not clear enough for me to provide a simplified explanation. Could you please provide more context or details about what you mean by "Expansion"?
Select...
You have advanced head and neck cancer that cannot be surgically removed and have at least one tumor that can be treated with radiation in the head and neck area, lungs, or liver.
Select...
You have advanced cancer in the lungs, liver, or other specified areas that cannot be surgically removed.
Select...
You have received treatment with a specific type of medication called anti-PD-1 before.
Select...
You have already received a type of treatment called anti-PD-1 therapy, but it did not work for you.
Select...
I'm sorry, but the criterion you provided is incomplete. Could you please provide more information or context for me to summarize it in plain and simple language?
Select...
You have already received a certain type of treatment called anti-PD-1 therapy and it did not work for you.
Select...
Your organs and bone marrow are working properly.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determination of the Recommended Dose
Secondary outcome measures
Assessment of the safety and feasibility of R3/RT/PD-1
Evaluation of the anti-tumor response of R3/RT/PD-1
Evaluation of the body kinetic profile of intratumorally injected NBTXR3
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: NBTXR3 activated by SABR followed by anti-PD-1 monotherapyExperimental Treatment4 Interventions
Intratumoral injection of NBTXR3 followed by SABR followed by monotherapy with nivolumab or pembrolizumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2210
Nivolumab
2014
Completed Phase 3
~4120
SABR
2013
Completed Phase 2
~70
NBTXR3
2011
Completed Phase 3
~210
Find a site
Who is running the clinical trial?
NanobiotixLead Sponsor
6 Previous Clinical Trials
805 Total Patients Enrolled
Elsa Borghi, MDStudy Director
NanobiotixPavel Tyan, MDStudy Director
NanobiotixMedia Library
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What potential hazards have been linked to the use of NBTXR3?
"With only limited data available on safety and efficacy, our evaluation of NBTXR3's risk profile was rated a 1."
Answered by AI
Is the recruitment phase for this research still open?
"Affirmative. According to the clinicaltrials.gov database, this research trial is actively seeking participants; it was first posted on January 16th 2019 and last revised October 25th 2022. 145 candidates need to be enrolled from 11 distinct locations."
Answered by AI
What is the participant capacity for this clinical investigation?
"This clinical trial necessitates the inclusion of 145 qualified participants. Patients may be recruited from any one of several sites, such as University of Chicago Medical Center in Chicago and James Graham Brown Cancer Centre at University of Louisville in Kentucky."
Answered by AI
How many Canadian healthcare facilities are conducting research on this topic?
"Recruiting for this trial is occuring at 11 different medical centres, including the University of Chicago Medical Center in Chicago, University of Louisville, James Graham Brown Cancer Center in Louisville and Banner MD Anderson Cancer Centre in Gilbert."
Answered by AI
Who else is applying?
What state do they live in?
Arizona
What site did they apply to?
Banner MD Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+