CLINICAL TRIAL

NBTXR3 for Oral Squamous Cell Carcinoma

Recruiting · 18+ · All Sexes · Boston, MA

This study is evaluating whether a combination of radiation and a drug may help treat cancer.

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About the trial for Oral Squamous Cell Carcinoma

Eligible Conditions
Breast Neoplasms · Liver Neoplasms · Metastasis From Malignant Tumor of Liver · Metastatic Renal Cell Carcinoma ( mRCC) · Metastatic Triple-Negative Breast Carcinoma · Metastatic Non-Small Cell Lung Cancer · Microsatellite Instability-High Solid Malignant Tumour · Metastasis From Malignant Tumor of Stomach (Disorder) · Metastasis From Malignant Tumor of Lung · Metastasis From Malignant Tumor of Bladder (Disorder) · Carcinoma · Neoplasm Metastasis · Neoplasms, Second Primary · Squamous Cell Carcinoma of Head and Neck · Urinary Bladder Neoplasms · Carcinoma, Merkel Cell · Radiotherapy · Carcinoma, Squamous Cell · Uterine Cervical Neoplasms · Melanoma · Stomach Neoplasms · Microsatellite Instability · Disease · Immunotherapy · Metastasis From Malignant Tumor of Cervix · Metastatic Squamous Cell Carcinoma · Metastasis From Malignant Melanoma of Skin (Disorder) · Neoplasms · Neuroendocrine Carcinoma of the Skin

Treatment Groups

This trial involves 2 different treatments. NBTXR3 is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Experimental Group 1
Pembrolizumab
DRUG
+
Nivolumab
DRUG
+
SABR
RADIATION
+
NBTXR3
DRUG
Experimental Group 2
NBTXR3
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2950
Nivolumab
2014
Completed Phase 3
~4470
SABR
2013
Completed Phase 1
~20
NBTXR3
2011
Completed Phase 3
~210

Eligibility

This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Life expectancy >12 weeks
Has not received prior anti-PD-1 therapy (i.e., anti-PD-1 naïve) or is currently receiving anti-PD-1 therapy and can be considered an anti-PD-1 non-responder (per SITC guidelines)
Has at least one tumor lesion that can be accurately measured according to RECIST 1.1. and is amenable for intratumoral injection
ECOG performance status 0-2
Negative pregnancy test ≤ 7 days prior to NBTXR3 injection in all female participants of child-bearing potential
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 24 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 24 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether NBTXR3 will improve 1 primary outcome and 3 secondary outcomes in patients with Oral Squamous Cell Carcinoma. Measurement will happen over the course of 24 months.

Assessment of the safety and feasibility of R3/RT/PD-1
24 MONTHS
Assessment of the number of participants with related late onset toxicities defined as any Grade ≥3 AE occurring after the EOT visit and determination of the number of participants with feasible NBTXR3 intratumoral injection
Determination of the Recommended Dose
24 MONTHS
Determination of DLTs, the MTD (if possible), and RP2Ds for each cohort
Evaluation of the anti-tumor response of R3/RT/PD-1
24 MONTHS
Evaluation of the Objective Response Rate: complete or partial response, as defined by RECIST 1.1 and iRECIST
Evaluation of the body kinetic profile of intratumorally injected NBTXR3
24 MONTHS
Evaluation of the time-course dependent accumulation of hafnium in blood and urine following NBTXR3 intratumoral injection

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can oral squamous cell carcinoma be cured?

There is a need to reweigh the pros and cons of ablative techniques for oral cancer treatment, considering that most localised cases could survive without significant morbidity. The current results of the analysis should be considered carefully before applying these ablative techniques routinely. Long-term follow up studies are required on larger scale to confirm these results.

Anonymous Patient Answer

What are the signs of oral squamous cell carcinoma?

The signs of oral SCCs are nonspecific and often misdiagnosed. Many of them may be observed or experienced by any person in the community, but these can also occur in healthy individuals or individuals without any specific signs or symptoms and can be associated with premalignant lesions. If it is not clear that the lesion is premalignant or cancerous, careful surveillance of the area in which the lesion is located, especially the lips, is necessary for early detection of oral SCCs, so that it can be treated before it spreads to other regions. It is important to recognize the signs of oral SCCs and to consult a surgeon, a dentist and a periodontist.

Anonymous Patient Answer

What is oral squamous cell carcinoma?

Oral SCC often arises in areas of chronic oral disease, such as dental caries, periodontal pathoses, and tobacco use, and progresses slowly over several decades, while the overall risk of development is low. These factors should be monitored in patients with chronic oral disease for detection at an early stage and for appropriate medical or surgical management.

Anonymous Patient Answer

How many people get oral squamous cell carcinoma a year in the United States?

Approximately 3,350 new cases of OSCC are diagnosed each year on the overall population. Overall, the lifetime risk of OSCC appears to be 0.14%, but is higher among older men.

Anonymous Patient Answer

What are common treatments for oral squamous cell carcinoma?

Because of the lack of national guidelines for oral cancer treatment, different centers may employ different treatments. A systematic collection of these treatments would be beneficial to patients in the decision of treatment. Therefore, clinicians should compile these data.

Anonymous Patient Answer

What causes oral squamous cell carcinoma?

Oral squamous cell carcinoma may arise from several factors, some hereditary, others environmentally and social. Smoking is the most commonly cited cause of oral cancer, although in our experience it is less important than other risk factors.

Anonymous Patient Answer

What are the chances of developing oral squamous cell carcinoma?

Overall, 3.4% of patients in this study had oral SCC at the time of diagnosis of OLP. The occurrence of OSCC was significantly increased in the patients with multiple other comorbidities and smoking and alcohol consumption. We believe that routine use of a thorough oral examination is warranted in patients with multiple comorbidities, smokers, regular alcohol consumers, and those with early stages of OLP.

Anonymous Patient Answer

Does nbtxr3 improve quality of life for those with oral squamous cell carcinoma?

Although this study found NBTXR3 to be well tolerated and associated with significant improvements in QoL for patients with OSCC, larger trials are needed to determine the overall effect on cancer survival.

Anonymous Patient Answer

What is the primary cause of oral squamous cell carcinoma?

Although the exact pathogenesis is not known, it is widely accepted that cigarette smoking and ethanol are the primary risk factors for OSCC. In a recent study, findings of the current review also support previous findings that other exogenous agents, including excessive ultraviolet radiation and ionizing radiation, are also important. In the absence of strong epidemiological evidence to support these other risk factors, further studies are necessary to further evaluate whether they contribute to OSCC development.

Anonymous Patient Answer

What is nbtxr3?

Nbxr3 may be involved in the regulation of cell proliferation, invasiveness, and differentiation in OSCC. Since Nbxr3 upregulation enhances proliferation, invasion, chemotherapy resistance, and survival of OSCC cells, it is a promising therapeutic target of OSCC.

Anonymous Patient Answer

What are the common side effects of nbtxr3?

Most side effects with nbtxr3 were mild and resolved. The most common side effect after treatment was diarrhea. No serious side effects with nbtxr3 were reported.

Anonymous Patient Answer

What are the latest developments in nbtxr3 for therapeutic use?

Because the nbtxr3 gene is a key to mammalian gene function, this gene has been one of the most investigated genes in vertebrates. The gene nbxr3 is one of the most extensively studied genes in vertebrates, with some studies that have explored the function of this gene in many tissues and conditions. This is because some of its variants seem to be associated with several diseases and syndromes. For example, humans with a specific set of single base substitution in this gene express the phenotype of multiple endocrine neoplasia Type 4 (MEN4), but not in other patients. Similarly, mice, rats, mice with a mutated gene encoding GPCR180 have different phenotypes as compared to normal mice.

Anonymous Patient Answer
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