Pembrolizumab for Cancer

1
Effectiveness
2
Safety
M D Anderson Cancer Center, Houston, TX
Cancer+3 More
Pembrolizumab - Biological
Eligibility
18+
All Sexes
Eligible conditions
Cancer

Study Summary

This study is evaluating whether a drug called pembrolizumab can help treat patients with high risk oral intraepithelial neoplasia.

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Eligible Conditions

  • Cancer
  • Neoplasms
  • Carcinoma in Situ
  • Oral Intraepithelial Neoplasia
  • Oral Cavity Carcinoma

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Pembrolizumab will improve 1 primary outcome in patients with Cancer. Measurement will happen over the course of From randomization to the development of histologically confirmed oral cancer or death of any cause, whichever occurs first, assessed up to 7 years.

Year 7
Oral cancer-free survival

Trial Safety

Safety Estimate

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

Trial Design

2 Treatment Groups

Arm A (observation)
Arm B (pembrolizumab)

This trial requires 15 total participants across 2 different treatment groups

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

Arm B (pembrolizumab)Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Arm A (observation)
Other
Patients undergo observation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from randomization to the development of histologically confirmed oral cancer or death of any cause, whichever occurs first, assessed up to 7 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from randomization to the development of histologically confirmed oral cancer or death of any cause, whichever occurs first, assessed up to 7 years for reporting.

Closest Location

M D Anderson Cancer Center - Houston, TX

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:
For subjects with total bilirubin levels > 1.5 ULN, the serum total bilirubin must be < 1.5 X ULN or the direct bilirubin must be < ULN. show original
The enzymes aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) should not exceed 2.5 times the upper limit of the normal range for healthy people. show original
Histological evidence of oral intra-epithelial neoplasia within 12 months prior to enrollment; subjects with a history or clinical diagnosis suggestive of oral intra-epithelial neoplasia, or patients with a history of invasive oral cancer are eligible, but must have a confirmed histological diagnosis of oral intra-epithelial neoplasia before randomization; histological evidence of oral intraepithelial neoplasia on an invasive oral cancer resection specimen is acceptable; a visible, measurable, clinical lesion (such as leukoplakia and/or erythroplakia) is not required; only individuals with high risk profiles will be considered eligible for randomization; high risk profiles are defined as patients without a prior oral cancer and have loss of heterozygosity (LOH) at 3p14 and/or 9p21 plus at least at one additional chromosomal site (4q,8p,11p,13q, or 17p) or patients with a prior oral cancer history and have LOH at 3p14 and/or 9p21; all high risk patients must also meet the additional eligibility criteria
The person has a very poor performance status and is unable to carry out normal activities. show original
An absolute neutrophil count of at least 1,500/mcL is required. show original
A platelet count of 75,000 or more is considered high. show original
Please let us know if you are able to consent to research and willing to sign our consent form. show original
, and have a negative pregnancy test Be at least 18 years old on the day you sign the consent form for the trial, and have a negative pregnancy test. show original
If you are able to, please provide a tissue sample from your newly obtained oral biopsy. show original
Women who could potentially become pregnant should have a negative pregnancy test less than 72 hours before receiving the first dose of the study medication 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.

How many people get cancer a year in the United States?

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Between 1.4 and 1.8 million people are diagnosed with an invasive cancer every year in the United States. This is in addition to an unknown number of invasive cancers that are detected, but do not result in a diagnosis. The public health importance of these numbers is uncertain.

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What causes cancer?

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Genetic predisposition and lifestyle factors are very closely tied to the development of many cancers. But it can be hard to tell what is an environmental and what is a hereditary cause, because these types of risk factors often co-exist. While genetic predisposition to cancer is widely accepted, environmental risk factors cannot be eliminated and can even be an important element in disease onset.\n

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What is cancer?

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The word cancer is often used as an insult meaning "uncommon illness." This should be discouraged, because it promotes an inadequate perception of risk. The word cancer can also be used as an end in itself, implying the illness is an affliction, rather than merely an unwanted sign or symptom of disease. On this basis, the word cancer is actually the most appropriate in modern English.

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Can cancer be cured?

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If cancer is curable, then there is no such thing as death from cancer. For those afflicted with the disease, one would have to be very ill to die from cancer; yet, even in cases of very long illness, the death usually occurs from something unrelated to cancer. The term "cure", if used in this sense, must be construed as ‘curing’ the state of cancer, so that a human being can say he or she is cured of cancer, which does not mean that the cancer (of which the human being is no longer aware) has, in every sense, been cured of being cancer. Thus, it is meaningless and even misleading to say that cancer has been cured.

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What are the signs of cancer?

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Cancers frequently result in symptoms that are painful, bulky, and may involve the entire body. Cancer often presents with swelling and/or redness at the site of the tumor. Some cancer, such as breast cancer, may have symptoms that involve the skin.\n

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What is the latest research for cancer?

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The advances in science from a genetic and molecular level to clinical settings for understanding of tumor development are tremendous and are ongoing. The development of new technologies and new therapies for the treatment and improvement of cancer is also progressing from preclinical discoveries through Phase I trials to larger randomized studies and finally to clinical trials to show the benefit of these therapies. It is crucial to acknowledge and remember that the first successful new cancer drug is often years after its discovery in preclinical models, because drug development is an expensive and slow process, and many new drugs are never commercialized.

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What is the average age someone gets cancer?

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Over the lifetime of a person, they appear to develop various cancers at different average ages. The most frequent cancers that are likely to be seen over a person's lifetime are non-melanoma skin cancer, endometrial cancer, lung cancer and stomach cancer. These are not necessarily in the most common demographic groups which is the age range of the average Australian aged 45-69

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Is pembrolizumab safe for people?

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The safety profile is comparable to other IMs. The most frequent adverse events were fatigue and infusion reactions, whereas most common discontinuations were related to infusion reactions. Only 1.7% of patients experienced cardiac complications, whereas all patients experienced serious infusion reactions.

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What are the common side effects of pembrolizumab?

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The incidence of side effects was moderate to severe. The most common side effects were fatigue, diarrhea, abdominal pain, nausea, dizziness, decreased appetite and muscle/muscle damage.

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Does cancer run in families?

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Cancers seem to often run in families with an increased chances of siblings developing the disease. The causes of this relationship remain unknown. It has been reported that a few familial cancers have been observed, this includes ovarian and breast cancers. Individuals with familial cancers often show an earlier age at onset of illness. Families are also at an increased risk for having cases of multiple cancers with an increased number of cancers per individual compared to the general population. These relationships between familial cancer and early onset of cancer suggest a possible genetic link in oncogenesis.

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What is the survival rate for cancer?

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The survival rate for a person who has cancer is not the same for every cancer. The survival rates depend on gender, age of the patient, the type of cancer, and other factors. But there is a general pattern that cancer has a higher survival rate when the patient is between the ages of 0‑14 yr old. More importantly, the survival rates for cancer is always significantly higher than the survival rates for other diseases. The survival rates are the worst for the deadliest cancers. In the past decade, improvement in survival rates for cancer is much greater than it was for any other disease. The cancer mortality rates have declined significantly over the past three decades.

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