Cemiplimab-Rwlc for Oral Squamous Cell Carcinoma

Phase-Based Estimates
1
Effectiveness
2
Safety
University of Miami, Miami, FL
Oral Squamous Cell Carcinoma+7 More
Cemiplimab-Rwlc - Drug
Eligibility
18+
All Sexes
Eligible conditions
Oral Squamous Cell Carcinoma

Study Summary

This study is evaluating whether a new immunotherapy drug may help improve outcomes for individuals with head and neck cancer.

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Eligible Conditions

  • Oral Squamous Cell Carcinoma
  • Squamous Cell Carcinoma of Head and Neck
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Squamous Cell Carcinoma of the Oral Cavity
  • Squamous Cell Carcinoma of Hypopharynx
  • HNSCC
  • Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)
  • Squamous Cell Carcinoma of the Larynx

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Cemiplimab-Rwlc will improve 1 primary outcome and 3 secondary outcomes in patients with Oral Squamous Cell Carcinoma. Measurement will happen over the course of Up to 9 months.

Up to 1 year
PFS Rate
Up to 2 years
Overall Survival (OS)
Progression-Free Survival (PFS)
Up to 9 months
Incidence of Treatment-Related Toxicity and Adverse Events

Trial Safety

Safety Estimate

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

Trial Design

2 Treatment Groups

Control
Cemiplimab After CRT in HNSCC

This trial requires 44 total participants across 2 different treatment groups

This trial involves 2 different treatments. Cemiplimab-Rwlc 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 2 and have already been tested with other people.

Cemiplimab After CRT in HNSCC
Drug
Participants will receive Cemiplimab for 6 consecutive months (a total of 8 cycles) 14-42 days after completion of standard of care CRT.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cemiplimab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 2 years for reporting.

Who is running the study

Principal Investigator
C. I.
Prof. Chukwuemeka Ikpeazu, Associate Professor of Clinical
University of Miami

Closest Location

University of Miami - Miami, FL

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:
Patients with Stage IV HNSCC were treated with radiation therapy and chemotherapy prior to receiving radiation therapy show original
The patient has a good performance status, which means they are able to carry out everyday activities. show original
This text is discussing the histological diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx show original
The American Joint Committee on Cancer has designated the stage of squamous cell carcinoma of the oral cavity, larynx or hypopharynx as III-IVB. show original
This person has a cancer that has spread to their oropharynx and it is at stage III-IVB. show original
The patient has oropharyngeal cancer that is in stage II or III according to the AJCC system. show original
The tumor must have a documented score of 1 or greater for PD-L1 on immunohistochemistry. show original
ANC of at least 1,000/µL or 1.0 x 10^9/L. show original
Platelets that are 75,000 or more per microliter or 100,000,000 or more per liter. show original
There were no signs of any progressive disease when they enrolled in the study. show original

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 common treatments for oral squamous cell carcinoma?

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Oral squamous cell carcinoma is usually treated surgically by external beam radiation therapy or by intravascular brachytherapy. Chemotherapy is often used and often effective, but is more useful in early stages. In recent years, adjuvant chemotherapy has proven to be useful in advanced stages.

Unverified Answer

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

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Around 5,000 people develop a new oral carcinoma a year in the United States. Most of these cases are attributable to tobacco use. Most of the time, this is in addition to a previous malignancy, which may have been caused by the same exposures or by carcinogens already in the mouth.

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What are the signs of oral squamous cell carcinoma?

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The signs and symptoms of oral SSCC are nonspecific and difficult to detect until advanced disease. The most informative signs are those with a temporal or regional habit. The signs and symptoms in a patient with a diagnosis of SSCC should be asked about.

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What is oral squamous cell carcinoma?

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OSCC is not a cancer common in the UK; its incidence rate is low. Most cases reported are in the 25-50 age group. For this reason, there is a real risk of unnecessary treatment that will not help the patient's long-term well-being. Oral surgery requires a high degree of expertise; there is a case for a high specialist referral centre with multidisciplinary team-based management at the forefront of the team. A good collaboration with medical oncologists is needed.

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Can oral squamous cell carcinoma be cured?

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Data from a recent study indicated the importance of early detection and treatment when OSCC was diagnosed. Nevertheless, treatment can not totally eliminate or cure OSCC. Therefore, OSCC patients and their families should be advised to know the information before treatment is chosen.

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What causes oral squamous cell carcinoma?

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Most oral cancers occur from environmental factors. High-risk groups that have other disease predispositions, such as smoking, drinking heavily, or having a family history of cancer, also have an increased risk. High-risk groups that do not have any predisposition to cancer have a low cancer risk. Tobacco is the prime cause of oral cancer in this group.

Unverified Answer

How serious can oral squamous cell carcinoma be?

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Results from a recent clinical trial suggest that oral cancer patients with high-grade tumors, especially those with T3 or T4 tumors, have a significantly higher risk of DM and renal (kidney) cancer. However, OSCC is generally a disease which appears after other chronic diseases are diagnosed. This makes it difficult to treat even patients with localized oral cancer. It is generally impossible to diagnose before other chronic diseases are diagnosed. This means that when oral cancer is diagnosed, oral cancer is frequently already disseminated. When the oral cancer is localized, treatment, as for other cancers, should be carried out.

Unverified Answer

Is cemiplimab-rwlc safe for people?

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The Phase I experience demonstrated that cemiplimab at a dose of 5 mg/m(2) weekly is safe and well-tolerated in people with advanced solid tumors or, more particularly, metastatic NSCLC.

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

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None. Most studies are low-quality and need further assessment. It should be considered to use randomised controlled trials for oral cancer treatment. More studies about oral oncology are needed to identify treatment patterns and trends in the last three years.

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Does cemiplimab-rwlc improve quality of life for those with oral squamous cell carcinoma?

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Cemiplimab-rwlc treatment significantly increased QoL in the majority of patients with oral SCC. Further investigation is warranted to determine the exact role of this antibody and its possible utility in the treatment of oral SCC.

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What is the latest research for oral squamous cell carcinoma?

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The current literature has continued to reveal the need for targeted therapies as well as the use of combinations of agents against oral squamous cell carcinoma. In light of advancements in molecular and cellular biology, targeted therapies against oral cancer will provide patients with a more individualized treatment strategy.

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What does cemiplimab-rwlc usually treat?

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For metastatic disease with progressive disease progression, pembrolizumab-rwlc should be considered for patients with BRAF V600 mutation or those who are treated with BRAF V360 mutation. For patients with BRAF V180 mutation or those who are treated with BRAF V160 mutation, cemiplimab-rwlc may also be considered. Patients without a BRAF mutation should be treated with the standard of care, cemiplimab treatment.

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