CLINICAL TRIAL

VSV-IFNβ-NIS for Oral Squamous Cell Carcinoma

Locally Advanced
Metastatic
Refractory
Recruiting · 18+ · All Sexes · Rochester, MN

This study is evaluating whether a combination of two drugs may help treat lung cancer or head and neck cancer.

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About the trial for Oral Squamous Cell Carcinoma

Eligible Conditions
Non-Small Cell Lung Carcinoma (NSCLC) · Squamous Cell Carcinoma of Head and Neck · Carcinoma, Neuroendocrine · Neuroendocrine Carcinomas · Tumors, Solid

Treatment Groups

This trial involves 4 different treatments. VSV-IFNβ-NIS is the primary treatment being studied. Participants will be divided into 4 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Experimental Group 1
VSV-IFNβ-NIS
BIOLOGICAL
+
Pembrolizumab
BIOLOGICAL
Experimental Group 2
VSV-IFNβ-NIS
BIOLOGICAL
+
Pembrolizumab
BIOLOGICAL
Experimental Group 3
VSV-IFNβ-NIS
BIOLOGICAL
+
Pembrolizumab
BIOLOGICAL
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About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VSV-IFNβ-NIS
2017
Completed Phase 1
~80
Pembrolizumab
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Arm 2: dose level 2 and above: Advanced and/or metastatic solid tumors for which no existing standard of care is felt to provide clinical benefit The first arm is for people with advanced or metastatic solid tumors for which no standard of care exists and is not considered to provide clinical benefit show original
Arm 2 is for people with advanced or metastatic NSCLC or NEC that has progressed during treatment with a PD-1 or PD-L1 checkpoint inhibitor, for whom no other treatments are considered beneficial. show original
The patient has advanced or metastatic NEC that has progressed during treatment with a PD-1 or PD-L1 checkpoint inhibitor, and no existing treatments are believed to provide any clinical benefit. show original
The person's organ function is adequate if their laboratory values fall within a certain range, and this was determined fewer than two weeks before they registered. show original
A person with a performance status of 0 or 1 on the ECOG Performance Scale is unable to work or carry out normal activities. show original
The life expectancy of a person with cancer who is not on active anticancer therapy is more than three months. show original
I agree to provide biological samples for the duration of the study, including a fresh tumor biopsy sample. show original
There is no need for a female patient of childbearing potential to take a pregnancy test before receiving treatment with Breztri. show original
Patients with advanced or metastatic NSCLC who have progressed radially during treatment with a PD-1/PD-L1 immune checkpoint inhibitor may be eligible for Arm4 show original
Measurable disease based on RECIST 1.1. The first 3 patients in the safety run-in phase do not need measurable disease. Part C: advanced NEC (neuroendocrine carcinoma based on histopathology according to WHO criteria. Patients with small cell carcinoma, large cell neuroendocrine carcinoma, and neuroendocrine carcinoma not otherwise specified, of any primary organ are eligible in which radiological progression has been demonstrated during therapy with a PD-(L)1 immune checkpoint inhibitor, and for which no existing options are felt to provide clinical benefit.
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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: 6 months
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 6 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 VSV-IFNβ-NIS will improve 2 primary outcomes and 5 secondary outcomes in patients with Oral Squamous Cell Carcinoma. Measurement will happen over the course of 21 days.

Safety run-in arm: Number of participants with treatment related adverse events (NCI CTCAE; Version 4.03)
21 DAYS
Assessment of safety and toxicity of intravenous VSV-IFNβ-NIS in combination with pembrolizumab therapy
21 DAYS
Expansion arms: Overall response rate (ORR)
43 DAYS - 6 MONTHS
proportion of patients in the analysis population who have complete response (CR) or partial response (PR) based on RECIST 1.1 imaging
43 DAYS - 6 MONTHS
Overall Survival (OS)
6 MONTHS
Survival time is defined as the time from registration to death due to any cause.
6 MONTHS
Adverse events
6 MONTHS
All eligible patients that have initiated treatment will be considered evaluable for assessing adverse event rate(s). The maximum grade for each type of adverse event will be recorded for each patient.
6 MONTHS
Disease Control Rate (DCR)
6 MONTHS
proportion of patients in the analysis population who have complete response (CR), partial response (PR) or stable disease (SD) based on RECIST 1.1 imaging on day 43.
6 MONTHS
Progression Free Survival (PFS)
6 MONTHS
Progression-free survival is defined as the time from registration to the earliest date documentation of disease progression or death due to any cause
6 MONTHS
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Patient Q & A Section

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

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

About 5.6 million adults are currently living with OSCC and at the time would have undergone surgery or a biopsy if they were treated on the basis of current staging and diagnostic criteria within a given calendar year. Assuming that 30-day mortality is 7% and 5-year survival from cancer is 15%, OSCC incidence would be around 23,000 cases a year. If treatment is improved and the standard treatment duration is increased to five years or more, then this would lead to a reduction in the incidence of advanced or metastatic disease by about 1,000 cases a year. OSCC incidence in children may be much less common than currently believed.

Anonymous Patient Answer

What causes oral squamous cell carcinoma?

The primary cause of OSSCC is most often identifiable during the course of treatment for an underlying head and neck condition. This information may help provide patients with accurate risk information and help guide treatment decisions.

Anonymous Patient Answer

What are common treatments for oral squamous cell carcinoma?

Current treatment patterns for patients with oral carcinoma vary widely from the current national guidelines. The differences may impact the survival and quality of life for patients. As we have established, a significant proportion of patients with oral cancer receive no therapies for their disease. A review of these patients might allow for increased treatment and better outcomes for patients with oral cancer. For patients evaluated and treated in other regions, additional studies concerning treatment pathways are needed.

Anonymous Patient Answer

Can oral squamous cell carcinoma be cured?

Recent findings may not be generalized to other types of cancer. The long-term cancer outcome after cure of OSCC remains to be determined. Recent findings may not be generalized to other types of cancer.

Anonymous Patient Answer

What is oral squamous cell carcinoma?

The prognosis of OSCC is very poor compared with that of other cancers. However, when this cancer is localized, there are many ways which can be used to treat it, such as radiotherapy or chemotherapy. For example, it has been demonstrated that the prognosis of patients with oral SCC is better when radiotherapy is used. [To stop the disease growing quickly and start treatments earlier, we need to gather information about OSCC, investigate what treatments are effective, and make treatment plans based on those results. It is very important to understand this cancer's biology. Then we can determine better treatment options for patients. If we want to prevent this cancer from becoming more widespread, we must find treatment strategies to change its biology.

Anonymous Patient Answer

What are the signs of oral squamous cell carcinoma?

Frequent cheek chewing or a foul odour (either of the mouth or elsewhere on the face) may be a sign of oral cancer. Weakness and soreness in the mouth or in the jaw is another sign. Other signs of oral cancer include a lump or swelling (a lump on the floor of the mouth, in the mouth or on the gums), bleeding from the gums into the mouth or the nose, or a ulcer or sore under the gum. It is also important to exclude the spreading of cancer to other (non-oral) body sites.

Anonymous Patient Answer

What does vsv-ifnβ-nis usually treat?

Patients with persistent oral cavity squamous cell carcinoma in remission after treatment with vv-ifnβ-nis have an overall and disease-free survival similar to those who receive treatment with vv-ifnβ-sis alone. The vv-ifnβ-nis is a useful treatment option in patients with oral cavity squamous cell carcinoma in sustained complete clinical remission after definitive therapy, and also merits further investigation.

Anonymous Patient Answer

What are the common side effects of vsv-ifnβ-nis?

The vast majority of the common adverse events observed with vsv-ifnβ-nis in the two trials were mild to moderate, and occurred almost exclusively in patients who received the higher dose of IFNβ. There was no difference in the frequency or severity of any of the observed common adverse events between vsv- ifnβ-nis at doses of 50 μg and 1000 μg. The rate of infusion-related events was higher with vsv-ifnβ-nis than with IFNβ. Patients' comfort during treatment with vsv-ifnβ-nis was not impaired.

Anonymous Patient Answer

Is vsv-ifnβ-nis safe for people?

As the use of the VSV-IFN-B for OCM treatment for head and neck cancer (HNC) was found to be safe it could be considered as an alternative to other forms of antiviral treatment during the treatment of advanced HNC.

Anonymous Patient Answer

Have there been any new discoveries for treating oral squamous cell carcinoma?

There were no new discoveries. For the development of new treatments for oral cancer, there needs to be a careful selection of patients so that only those patients are selected for treatment who have a high probability of cure.

Anonymous Patient Answer

Have there been other clinical trials involving vsv-ifnβ-nis?

Overall, it is unlikely that there will be more trials with this drug compared to the current therapies. It is also unlikely that there will be an increase of toxicity when using the IFNbeta-3b drug compared to the existing therapies.

Anonymous Patient Answer

What are the latest developments in vsv-ifnβ-nis for therapeutic use?

Ifnβ in combination with IFNβ is active and well tolerated. However, it increases the risk of opportunistic infections. It also has the potential to initiate the development of anti-tumor immunity. Further combination studies could provide more information.

Anonymous Patient Answer
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