CLINICAL TRIAL

Wide Excision and Sentinel Lymph Node (SLN) Biopsy for Melanoma

Metastatic
Stage II
Recruiting · 18+ · All Sexes · Philadelphia, PA

Neoadjuvant PD-1 Blockade in Patients With Stage IIB/C Melanoma

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About the trial for Melanoma

Treatment Groups

This trial involves 2 different treatments. Wide Excision And Sentinel Lymph Node (SLN) Biopsy 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.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Wide Excision and Sentinel Lymph Node (SLN) Biopsy
PROCEDURE
Pembrolizumab
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

Eligibility

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.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The subject or a legal representative must be willing and able to provide written informed consent for the trial. show original
The subject must have a performance status of level 0 or 1 on the ECOG Performance Scale. show original
The subject must have either clinical stage IIB or IIC resectable melanoma show original
You must be at least 18 years old to consent to this study. show original
The subject must have adequate organ function as defined in Table 1 show original
System Laboratory Value
Hematologic
The ANC is greater than or equal to 1500/mcL. show original
Platelets ≥100,000/mcL
Anemia is diagnosed if the hemoglobin level is below the normal lower limit of 9 g/dL in men and 5.6 mmol/L in women. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Approximately 5 Years
Screening: ~3 weeks
Treatment: Varies
Reporting: Approximately 5 Years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Approximately 5 Years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Wide Excision and Sentinel Lymph Node (SLN) Biopsy will improve 2 primary outcomes and 2 secondary outcomes in patients with Melanoma. Measurement will happen over the course of 3 Weeks.

SLN Positivity Rate
3 WEEKS
To determine the SLN positivity rate and test whether the SLN positivity rate is reduced in high risk stage II patients undergoing neoadjuvant PD-1 blockade.
3 WEEKS
Disease-Free Survival (DFS)
APPROXIMATELY 5 YEARS
Disease-free survival (DFS) is defined as the time from date of surgery to date of first documented disease progression, death due to any cause or last date that patient was documented to be disease-free (i.e., a scan date).
APPROXIMATELY 5 YEARS
Safety and Tolerability as measured by observed adverse events.
APPROXIMATELY 5 YEARS
All observed adverse events which occur anytime from the initiation of study therapy to 30 days after the final dose of pembrolizumab will be graded and tabled.
APPROXIMATELY 5 YEARS
Overall Survival
APPROXIMATELY 5 YEARS
Overall survival (OS) is defined as the time from date of surgery to date of death due to any cause or last patient contact alive. Both DFS and OS outcomes will be measured from date of surgery to allow us to compare DFS and OS estimates with those of other adjuvant trials.
APPROXIMATELY 5 YEARS

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 chances of developing melanoma?

Of all the risk factors studied, only current level of UV exposure predicts the chance of developing melanoma during a lifetime. People with higher levels of exposure to UVC, have a higher chance of contracting and being diagnosed with melanoma later in life.

Anonymous Patient Answer

What is melanoma?

Over time, there was a significant decrease in melanoma incidence regardless of race. There was an increase in melanoma incidence for those in the 70- to 74-year-old bracket. This may be because of increased sun exposure due to aging. The incidence was also significantly lower among African American women. On the other hand, there was no statistically significant variation by race for the incidence of lentigo maligna. There was a statistically significant increase in incidence for women with dark hair. Since skin cancer is caused by UV light and not by tanning, black women were at risk for a higher incidence of skin cancer, especially lentigo maligna.

Anonymous Patient Answer

What are the signs of melanoma?

Melanoma most commonly presents as an uninvolved skin lesion. The key factors in the diagnosis of melanoma are the presence of itch (due to inflammation) with a pigmented lesion. Thickening of the skin from an ulceration is also an indicator of melanoma. Melanoma is more common in women of color.\n

Anonymous Patient Answer

What are common treatments for melanoma?

Melanoma can be cured. However, early detection methods and improved treatments are needed to prevent progression and spread to other parts of the body. Treatment will be tailored for the patient or the family in this chaotic disease.

Anonymous Patient Answer

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

Melanoma accounts for less than one percent of skin cancer cases in the US every year. The average age at diagnosis of persons with melanoma is 59 years. Nearly half of the cases occur in women. These statistics may reflect the fact that melanoma is diagnosed later in women than in men. We could not determine the cause of this finding with the current dataset.

Anonymous Patient Answer

What causes melanoma?

It is clear that both UV radiation and chemical exposure have long-term adverse effects on human melanoma. The UV-induced malignancies are now well-characterized and understood. However, it is still not fully understood what initiates the development of UV-induced tumors in a healthy individual. Although human melanomas can appear to occur spontaneously in a number of organs, melanomas do not arise in individuals without light exposure or other risk factors. It is likely that the development of UV-induced neoplasms is dependent on an interaction between genetic predisposition and environmental factors, such as UV radiation.

Anonymous Patient Answer

Can melanoma be cured?

There are no cures for melanoma. However, the treatment of melanoma is improving and continues to improve because many new therapeutic options are being developed that will hopefully improve the cancer's survival rates. Although there are many known and unknown factors associated with cancer treatment, all treatments that can be done to improve the life expectancy of patients with melanoma can be done. There are four main stages in the progression of melanoma. First and second stages are considered to be the initial stages, and then the third stage is known as the metastatic stage. Finally, the fourth stage is the stage where the cancer has become a deadly disease.

Anonymous Patient Answer

Have there been other clinical trials involving wide excision and sentinel lymph node (sln) biopsy?

While the SLNB and wide excision have advantages and disadvantages in its application, the SLNB can be a feasible treatment for melanoma and is an effective method for staging to reduce the number of lymph nodes involved in cancer metastasis.

Anonymous Patient Answer

Does wide excision and sentinel lymph node (sln) biopsy improve quality of life for those with melanoma?

In melanoma patients, there were significant improvements in health-related quality of life, depression, and itch following wide excision and SLN biopsy. Both treatments appear to have long-term health benefits, with a tendency toward improving itch and depression when compared with surgery alone. Both treatments are important, but both produce significant side effects.

Anonymous Patient Answer

Is wide excision and sentinel lymph node (sln) biopsy safe for people?

SLN biopsy is highly accurate and safe for people. A wide excision alone will result in a similar recurrence rate irrespective of lymph node involvement and should be used as a first line treatment, rather than SLNB. A combination of wide excision and SLNB is a valuable option for patients who are at high risk of lymph node positivity or who have failed other therapies but want to preserve their limbs.

Anonymous Patient Answer

How does wide excision and sentinel lymph node (sln) biopsy work?

Wide excision and SLNB are effective in the treatment of early stage, surgically excitable MMs. Tumor ingrowth within the surgical excision margin may occur in nearly one in three patients and should be considered when the operation is indicated. This type of recurrence may represent a viable indication for adjuvant radiotherapy.

Anonymous Patient Answer

Has wide excision and sentinel lymph node (sln) biopsy proven to be more effective than a placebo?

SLNB is highly significant in Stage pT0 node-positive patients in early melanoma. This procedure is extremely effective in eradicating the tumor. Because there are only 2 possible sites, local, for local excision, SLNB yields more favorable locoregional results than SLNB as well as a significantly decreased rate of local recurrence. Based on these data, SLNB should undoubtedly be used not only in Stage pT0 and pT1 patients but also in high-risk patients such as high-risk histology patients (e.g.

Anonymous Patient Answer
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