Nivolumab for Oral Squamous Cell Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Johns Hopkins University, Baltimore, MD
Oral Squamous Cell Carcinoma+1 More
Nivolumab - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a combination of drugs may help reduce the risk of cancer returning in individuals who have had surgery to remove cancer.

See full description

Eligible Conditions

  • Oral Squamous Cell Carcinoma
  • Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Nivolumab will improve 2 primary outcomes and 4 secondary outcomes in patients with Oral Squamous Cell Carcinoma. Measurement will happen over the course of From neoadjuvant therapy to surgical resection, approximately 4 weeks.

Week 4
Immune Related Pathologic Response
Pathologic Response
Day 100
Feasibility of neoadjuvant Nivolumab in combination with HuMax or Cabiralizumab
Safety of neoadjuvant Nivolumab in combination with HuMax or Cabiralizumab
Year 5
Overall Survival
Relapse Free Survival

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

3 Treatment Groups

Cohort 3
1 of 3
Cohort 1
1 of 3
Cohort 2
1 of 3
Experimental Treatment

This trial requires 24 total participants across 3 different treatment groups

This trial involves 3 different treatments. Nivolumab is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Cohort 3
Drug
Nivolumab + another agent (which will be determined depending on results from Cohort 1 and Cohort 2) will be administered as an IV infusion.
Cohort 1Nivolumab + HuMax (BMS-986253) will be administered as an IV infusion.
Cohort 2Nivolumab + Cabiralizumab will be administered as an IV infusion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabiralizumab
Not yet FDA approved
Nivolumab
FDA approved
HuMax-IL8
2015
Completed Phase 1
~20

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 100 days after the last dose of study drug
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 100 days after the last dose of study drug for reporting.

Closest Location

Johns Hopkins University - Baltimore, MD

Eligibility Criteria

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.

Mark “yes” if the following statements are true for you:
The primary site should be a head and neck squamous cell carcinoma (including, but not limited to oral cavity, oropharynx, hypopharynx, or larynx, paranasal sinuses, nasal cavity). Squamous cell carcinoma of unknown primary, diagnosed in lymph nodes in neck, can be included but should be tested for p16 and confirmed with an HPV specific assay (testing NOT required for enrollment; can be done at an interval).
Subjects must be human papillomavirus (HPV) negative (confirmed testing for oropharyngeal primary tumors - if otherwise suspected HPV positivity e.g. some oral cavity or sinonasal tumors if e.g. absence of smoking) OR (if HPV+) be high risk based on a ≥20 pack year smoking history.
HPV testing is required per clinical standards
Subjects must have been determined to be candidates for surgical resection by a multidisciplinary team including a surgeon, a medical oncologist and a radiation oncologist. Resection should typically be definitive but may also be done for symptomatic control e.g. in the setting of (suspected) metastatic disease with dominant local symptoms.
Subjects must have at least one lesion that can be (or has been) biopsied at baseline.
Patients with metastatic disease (both HPV(-) and high-risk HPV(+) (i.e. ≥20 pack years of smoking) are allowed, as long as patients have an indication for surgery for locoregional disease, and a life expectancy of ≥6 months. Metastatic disease can be addressed with additional treatments after trial treatment, e.g. focal radiation, or additional systemic therapy (e.g. chemotherapy or as indicated a targeted therapy or standard of care immunotherapy).
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
Age greater than or equal to 18 years
Life expectancy of greater than 6 months
Patients must have normal organ and marrow function

Patient Q&A Section

What are common treatments for oral squamous cell carcinoma?

"This is the first study to highlight major differences between Chinese and Western patterns of treatment for ESCC. Chinese patients are less likely to be prescribed multiple therapeutic modalities, and are more likely to be prescribed chemotherapy alone. Chinese patients also have a higher rate of relapse than their Western counterparts." - Anonymous Online Contributor

Unverified Answer

What is oral squamous cell carcinoma?

"OS: OSA, dysbarbituria, and/or PSA level >or=3 ng/ml were associated with an increased risk of OSCC; moreover, OSCC could be predicted by age, family history, dysbarbituria, hypertension, and/or OSA regardless of age, race, sex and comorbidities." - Anonymous Online Contributor

Unverified Answer

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

"The high incidence of cancer of the esophagus suggests that carcinoma of the esophagus is likely a significant cause of death from oral cancer. This may partly account for the high incidence of squamous cell carcinoma lesions in oral cavity and the large number of patients who come to our unit annually. This is the first study to show this association with esophageal cancer. It is also a first study of a large number of patients with esophageal cancer to confirm that some patients die from this disease only. This reinforces the need for urgent and careful planning for any management approach, including any neoadjuvant therapy, in patients with advanced OSCC to minimize the consequences of the disease, including cancer bone and brain metastases." - Anonymous Online Contributor

Unverified Answer

Can oral squamous cell carcinoma be cured?

"Oral cancer can be cured. In selected circumstances, the use of surgery alone can be adequate and even curative; therefore, surgery can be the first approach in such cases." - Anonymous Online Contributor

Unverified Answer

What are the signs of oral squamous cell carcinoma?

"Cough, swollen neck gland, neck pain, and painless lumps, are the signs of oral squamous cell carcinoma. These symptoms may be associated with increased lymph node metastases. The location of the primary lesion, lymph node metastasis and histological type were the signs, which were significantly associated with the presence or absence of these painful or persistent signs. The incidence rate of these signs was lower in the women with the squamous cell carcinoma of skin, compared to the men, both in Taiwan and the western countries." - Anonymous Online Contributor

Unverified Answer

What causes oral squamous cell carcinoma?

"Over 10% (40/409) of patients had a family history of [head and neck (CNS) cancer, especially oral cancer (p. 0.0001<0.0001)] or oral leukoplakia. Recent findings of this study demonstrated a strong association or family history of head and neck cancer and oral cancer in patients who attended a major Cancer Centre. The study indicated that patients who developed oral squamous cell carcinoma could have a genetic predisposition to oral cancer similar to other cancers in the head and neck region, such as head and neck cancers, tongue and neck cancers, and oropharyngeal cancers. The role of the risk factors and genetic predisposition need further research." - Anonymous Online Contributor

Unverified Answer

What is the latest research for oral squamous cell carcinoma?

"Oral cancer, though not exclusive to the Mediterranean Basin, still has a disproportionately high toll of its victims. This is because many populations of the world lack the preventive measures offered by oral health education, especially smoking cessation. The risk for developing oral cancers is also heightened because of the socioeconomic and cultural challenges faced by developing countries that are still struggling to establish oral health systems. While the rate and severity of oral cancers is no less prominent in these countries, they lack many of the medical resources and capabilities to deal with the health related issues. Therefore, oral cancers remain a largely neglected topic in public health. It is therefore imperative that world leaders prioritize oral cancer prevention and treatment as a major global health campaign." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving nivolumab?

"This is the first documentation of nivolumab being studied prospectively in combination with standard of care treatment or in patients treated with a first line of chemotherapy. Overall, the most common adverse effects encountered were fatigue, diarrhea and skin hypersensitivity reactions. There were no grade ≥ 3 adverse effects." - Anonymous Online Contributor

Unverified Answer

Is nivolumab safe for people?

"Nivolumab was well-tolerated with no apparent increased risk of adverse effects compared with the controls for comparators. This safety profile is similar to previous published neoadjuvant studies; patients who receive nivolumab in the neoadjuvant setting report no increased adverse effects. This information is particularly important as a number of patients requiring adjuvant treatment may be denied neoadjuvant treatment due to poor oral health." - Anonymous Online Contributor

Unverified Answer

How quickly does oral squamous cell carcinoma spread?

"The tumour size and its initial location are the most important preclinical prognostic factors of OSCC. The OSCC tumour stage appears to be closely associated with local progression after radical treatment. Results from a recent paper therefore suggest that a careful determination of the clinical stage of the disease before treatment is required for the optimal management of individual cases." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in nivolumab for therapeutic use?

"Nivolumab is a useful treatment option for patients with a first line of chemotherapy failure and should be included in clinical practice guidelines, as in Japan nivolumab might become the first-line therapeutic agent for patients with lung cancer." - Anonymous Online Contributor

Unverified Answer

Is nivolumab typically used in combination with any other treatments?

"Nivolumab can be considered with other agents such as chemotherapy, targeted agents, immunotherapy (including immune checkpoint inhibitors) and radiotherapy. It can also be combined with surgical debridement in selected cases." - Anonymous Online Contributor

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