pepinemab + pembrolizumab for Oral Squamous Cell Carcinoma

Phase-Based Estimates
1
Effectiveness
1
Safety
Siteman Cancer Center - Washington University Medical Campus, Saint Louis, MO
Oral Squamous Cell Carcinoma+5 More
pepinemab + pembrolizumab - Drug
Eligibility
18+
All Sexes
Eligible conditions
Oral Squamous Cell Carcinoma

Study Summary

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

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Eligible Conditions

  • Oral Squamous Cell Carcinoma
  • Squamous Cell Carcinoma of Head and Neck
  • Relapse
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Recurrence
  • Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (HNSCC)
  • Metastatic Squamous Cell Carcinoma of the Head and Neck (HNSCC)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether pepinemab + pembrolizumab will improve 3 primary outcomes, 7 secondary outcomes, and 3 other outcomes in patients with Oral Squamous Cell Carcinoma. Measurement will happen over the course of 2 Years.

2 Years
Duration of Response (DoR)
Efficacy Endpoint
Evaluation of RP2D
Extent of Disease (EOD)
Immunogenicity Endpoint
Number of Subjects with Treatment Emergent Adverse Events (TEAE's).
On-Treatment Tumor Biopsies
Overall Survival (OS)
Pharmacodynamic (PD) Endpoint
Pharmacokinetic (PK) Endpoints
Progression Free Survival (PFS)
Serum and CSF Levels of Neuroinflammatory Cytokines
T- and B-Cell Quantitation by Flow Cytometry (TBNK)

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
pepinemab + pembrolizumab

This trial requires 65 total participants across 2 different treatment groups

This trial involves 2 different treatments. Pepinemab + Pembrolizumab 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 & 2 and have already been tested with other people.

pepinemab + pembrolizumab
Drug
Pepinemab will be administered at 20 mg/kg (with possible dose modifications to 15 mg/kg or 10 mg/kg, if the initial 20 mg/kg dose of pepinemab is determined not to be well tolerated) in combination with a fixed dose of 200 mg pembrolizumab, administered in separate IV infusions, Q3W.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

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

Closest Location

Siteman Cancer Center - Washington University Medical Campus - Saint Louis, MO

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Oral Squamous Cell Carcinoma or one of the other 5 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:
You must be at least 18 years old to participate. show original
People who want to be in a study have to sign a paper that says they understand what the study is, what they're getting into, and the risks and benefits. show original
People with cancer of the mouth, throat, or voice box that has been confirmed by a microscope slide or lab test are eligible for this study. show original
Subjects with PD-L1 expression must have their PD-L1 IHC scores (including CPS scores using an FDA approved test) tested within 6 months of screening or at screening. show original
The patient has measurable disease as assessed by the central imaging vendor or the local site investigator/radiology show original
The subjects must have a life expectancy of at least 12 weeks. show original
ANC ≥1,500/μL
The person's platelet count is more than 100,000 per microliter. show original
Subjects must have a cancer that has come back after treatment or that has spread to other parts of the body. show original
Participants in the study must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 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 causes oral squamous cell carcinoma?

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The incidence of OSCC has increased in recent decades in many countries of the world. This has been attributed to factors such as increased risk for xerostomia or a younger age at time of diagnosis. The role of hepatitis B and smoking is still unclear.

Unverified Answer

What is oral squamous cell carcinoma?

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Oral squamous cell carcinoma is a malignancy that originates in the oral mucosa and produces ulcers, swelling, redness, pain, and tenderness in the mouth of epithelial tissue. The disease is diagnosed after a biopsy is done to exclude the presence of a mycotic or other type of tumor. Oral cancers have a reputation as a cancer that involves only white people or persons of Jewish or Asian origins.\n

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What are the signs of oral squamous cell carcinoma?

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OST is a potentially curable disease with excellent prognosis. The signs of OST, which can mostly be detected in premalent stages of the disease, include painless and painful ulcers of the mouth and gingiva in relation to gingival hypertrophy, tooth mobility, black or green stains, ulcerated stomata (the mouth-breathing organs), swelling of the cheeks and cheeks, the cheeks as a part of the facial dimple (buccal mucosa), and a non-specific dental history including loss of teeth. These signs can reflect in a dental radiograph and can be observed in premalent stages of the disease.

Unverified Answer

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

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Findings from a recent study suggest that the incidence of oral SCC could be higher than estimates from prior studies due to the longer period from lesion to diagnosis.

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Can oral squamous cell carcinoma be cured?

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Although in this case, the tumours had metastasised to many parts of body, the treatment that consisted only of radiotherapy, plus one course of chemotherapy, resulted in a better local control of the tumour than other therapy options, when applied to localised condition.

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What are common treatments for oral squamous cell carcinoma?

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Generally, the survival of patients with oral cancer is very good, regardless of the type, sites, or stages of oral cancers. To improve the survival outcome for this type of cancer, clinicians need to improve treatment modalities.

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How serious can oral squamous cell carcinoma be?

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The 5-year survival rate for primary head and neck squamous cell carcinoma was 27% with a mean overall survival of 27 months. The survival rate for T1 was 60% with a mean overall survival of 16 months. Tumor diameter ≥ 3 cm was one of the most important prognostic factors for both T1 and T2 lesions, with a survival rate for T2 of 25% and T3 or worse of 30%. Overall survival for the entire cohort of 870 subjects was 26% with a mean overall survival of 21.5 months. The 5 year survival rate for patients with advanced T4 lesions was 7%, with a mean overall survival of 13.7 months.

Unverified Answer

What does pepinemab + pembrolizumab usually treat?

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The PEP-EZUMAB regimen is efficacious in patients who have previously received an chemotherapy regimen containing platinum plus taxanes in metastatic or locally advanced squamous cell carcinoma. It may be considered for treatment in patients with locally advanced or recurrent SSC.

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What is the latest research for oral squamous cell carcinoma?

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Oral cancer remains a major health problem, yet little progress over the past 10 years. The reasons for this lack of progress are unknown, but research to understand the biologic cause of OSCC and to treat it with less toxicity and greater effectiveness remain important. Understanding the biologic mechanism by which cancers become malignant and developing effective treatments to disrupt their transformation are fundamental to progress in OSCC. Clinical trials provide a platform for conducting research to meet this goal. If results in these trials show that new treatment strategies are effective, an important next step would be to conduct Phase III clinical trials for OSCC. Recent advances are also guiding treatment strategies for other forms of OSCC that are currently more common in Europe and the East.

Unverified Answer

Who should consider clinical trials for oral squamous cell carcinoma?

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The probability of receiving a trial might be higher for all patients, but most should look at their physicians, family member, or family practitioner first before enrolling. There is a much better idea of benefit to patients who have either systemic, local, and/or adjuvant treatment.

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What are the chances of developing oral squamous cell carcinoma?

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Of all the oral cancers studied in one large-scale longitudinal study, OSCC comprised 13% of the cases. Risk estimates of developing OSCC varied with age and sex, but it was always high. It was more common than expected in patients with a family history of buccal carcinoma, and it was less common than expected in patients with a family history of OSCC. This information may be useful for patient counseling and in risk stratification in oral cancer screening studies.

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Does oral squamous cell carcinoma run in families?

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Although many of the risk factors for oral cancer are known, only half of the cancers have a hereditary component and only a minority are due to germ-line mutations in one of the known TSGs.

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