Ipilimumab for Oral Squamous Cell Carcinoma

Phase-Based Estimates
1
Effectiveness
1
Safety
University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, PA
Oral Squamous Cell Carcinoma+12 More
Ipilimumab - Biological
Eligibility
18+
All Sexes
Eligible conditions
Oral Squamous Cell Carcinoma

Study Summary

This study is evaluating the side effects and best dose of ipilimumab when given together with cetuximab and IMRT in treating patients with previously untreated stage III-IVB head and neck cancer.

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Eligible Conditions

  • Oral Squamous Cell Carcinoma
  • Squamous Cell Carcinoma of Head and Neck
  • Head Neoplasms
  • Carcinoma, Squamous Cell
  • Carcinoma
  • Stage IVA Hypopharyngeal Squamous Cell Carcinoma AJCC v7
  • Stage IVB Laryngeal Squamous Cell Carcinoma AJCC v7
  • Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7
  • Stage IVB Oropharyngeal Squamous Cell Carcinoma AJCC v7
  • Stage III Hypopharyngeal Squamous Cell Carcinoma AJCC v7
  • Stage IVA Laryngeal Squamous Cell Carcinoma AJCC v7
  • Stage III Laryngeal Squamous Cell Carcinoma AJCC v6 and v7
  • Head and Neck Neoplasms
  • Stage IVB Hypopharyngeal Squamous Cell Carcinoma AJCC v7
  • Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Ipilimumab will improve 1 primary outcome and 7 secondary outcomes in patients with Oral Squamous Cell Carcinoma. Measurement will happen over the course of Up to 12 weeks.

Up to 12 weeks
Proportion of dose limiting toxicities at each dose level assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Up to 5 years
Clinical response by Response Evaluation Criteria in Solid Tumors criteria
HPV status
Myeloid-derived suppressor cell (MDSC) cell counts
Progression free survival
Serum factors and tumor infiltrates
T cell phenotypes
T regulatory cell counts

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
Treatment (cetuximab, IMRT, and ipilimumab)

This trial requires 19 total participants across 2 different treatment groups

This trial involves 2 different treatments. Ipilimumab is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Treatment (cetuximab, IMRT, and ipilimumab)Patients receive cetuximab IV over 60-120 minutes on days 1, 8, 15, and 22. Treatment with cetuximab repeats every 4 weeks for 2 courses. Beginning in week 2 of course 1, patients undergo concurrent IMRT 5 days per week for 7 weeks. Beginning in week 4 (day 1 of course 2) patients also receive ipilimumab IV over 90 minutes once every 21 days for 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients achieving disease progression may undergo surgery after completion of therapy.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
FDA approved
Cetuximab
FDA approved
Intensity-Modulated Radiation Therapy
2009
Completed Phase 3
~1250

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 5 years for reporting.

Closest Location

University of Pittsburgh Cancer Institute (UPCI) - Pittsburgh, PA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Oral Squamous Cell Carcinoma or one of the other 12 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
People with an intermediate risk of HPV/p16+ oropharyngeal squamous cell cancer have a smoking history of 10 pack-years or more, and/or evidence of nodal disease (N2 or higher), regardless of their smoking status. show original
This category includes cancer that has spread to nearby lymph nodes but not to distant parts of the body show original
High risk: any subsite other than the oropharynx, including the larynx or hypopharynx, or a HPV/p16-positive oropharynx subsite. show original
Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam
This means that the person's absolute neutrophil count is more than 1,200 cells per microliter of blood. show original
This text means that a person's platelet count should be at least 75,000/mcL. show original
No clinical evidence of hemolysis The total bilirubin level is less than 2 milligrams per deciliter show original
Patients should be newly diagnosed HNSCC, with no prior therapy for this disease
ECOG status is usually less than or equal to 1 (Karnofsky of at least 70%). show original
Leukocytes >= 3,000/mcL

Patient Q&A Section

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

What are the signs of oral squamous cell carcinoma?

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Signs of oral cancer involve the gums, the tongue and the cheeks. It is important to know what the signs are because they may be the first signs of cancer and should be managed accordingly by the health care professionals.

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Can oral squamous cell carcinoma be cured?

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Even though, many patients who are curable after primary IMRT with or without CCRT have a long-term disease-free survival, the survival was still not satisfactory.

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What are common treatments for oral squamous cell carcinoma?

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This article outlines some common treatments for oral SCC, and suggests that treatment can not be simplified to a single modality. The best therapy needs to be tailored to the individual patient.

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What causes oral squamous cell carcinoma?

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There is no consistent link between oral SCC and either tobacco or beer. No single environmental factor can be clearly identified, but the risk of developing oral SCC is higher in patients who have a sibling who is affected. Although the oral SCCs are often found in patients who drink alcohol, this is not true in patients from non-alcoholic families who have SCCs. The risk for developing oral SCC may also be an indicator of other underlying familial cancer syndromes, such as Li-Fraumeni syndrome.

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What is oral squamous cell carcinoma?

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The risk of developing oral SCC increases progressively with age, regardless of tobacco consumption. A previous history of non-alcoholic and alcoholic OJ and being a male are risk factors of oral SCC. Patients with oral and oropharyngeal SCCs require meticulous medical surveillance.

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

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The incidence of oral squamous cell carcinoma is higher than most other oral and pharyngeal cancer in the U.S. and is rising faster than many other forms of cancer. This is a global challenge to tackle in a global health arena.

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What does ipilimumab usually treat?

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There are many conditions that ipilimumab has been reported for, all [for example, autoimmune disorders and cancers] can have a variety of side effects, and in general, the side effects [at least what patients experience] may change depending on if it is used in clinic or if it is part of a trial. The side effects of ipilimumab vary based on the disease it treats. There is no way to tell where you will get side effects before taking the drug. For example, if you plan to use ipilimumab to treat an [autoimmune disorder] you may have some side effects while you are taking it. Once you start you may need to take the drug for your entire life.

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Does oral squamous cell carcinoma run in families?

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The occurrence of oral carcinoma in multiple members of a family would be an important finding in the differential diagnosis of oral cancer. The authors found no evidence that oral carcinoma runs in families.

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

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Although there have been many important discoveries in the treatment of oral squamous cell carcinoma, it is still extremely difficult to get these drugs into society.

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What are the common side effects of ipilimumab?

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Patients receiving ipilimumab experienced a substantial fraction (18-20%) of common side effects, comparable to those seen in clinical studies of ipilimumab but not matched cohorts receiving chemotherapy for cancer or immune checkpoint inhibitor with chemotherapy previously. This should be considered in the evaluation of the benefits and limitations of ipilimumab therapy in individual patients. summary: Data from a recent study lists common side effects of ipilimumab therapy. Clinical trials with ipilimumab in patients who received prior chemotherapy will be helpful for determining the most common side effects of ipilimumab.

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What is the latest research for oral squamous cell carcinoma?

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The use of molecular probes like immunohistochemistry or gene profiling in the evaluation of the biopsy is probably more likely to be a marker of the disease process rather than a marker of a particular disease state and should also be included in the clinical practice of oropharyngeal carcinoma management. As molecular markers improve in their sensitivity, specificity, and technical ease of use, more stringent clinical validation and incorporation of such biomarkers into prospective studies will be needed for better management of oro-pharyngeal carcinoma.

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What are the chances of developing oral squamous cell carcinoma?

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The chance of developing OSCC is 1%. The risk increases after sixty years of age, with the odds increasing until the age of eighty. The incidence at all levels of socioeconomic status is almost the same. In this population-based sample, smokers and smokers with other systemic cancers are at higher risk than those who did neither.

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