Pembrolizumab for Desmoplastic Melanoma

Not currently recruiting at 325 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the effectiveness of pembrolizumab, an immunotherapy drug, in treating desmoplastic melanoma, a rare type of skin cancer. The trial includes two groups: one for patients whose cancer can be surgically removed and another for those whose cancer cannot be removed. Pembrolizumab may help the immune system attack cancer cells and stop their growth. Patients with this type of melanoma who have not previously received systemic treatment and meet specific health criteria might be suitable for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people, offering patients a chance to contribute to important advancements in cancer therapy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot receive other cancer treatments or certain medications like systemic corticosteroids within 14 days before joining the trial.

Is there any evidence suggesting that pembrolizumab is likely to be safe for humans?

Research has shown that pembrolizumab is generally well-tolerated by people with desmoplastic melanoma. In one study, 89% of patients with melanoma that couldn't be removed by surgery responded to the treatment, with most experiencing tumor shrinkage. About 37% of these patients had a complete response, where their cancer was no longer detectable.

Regarding safety, another study examined the side effects of pembrolizumab and found the treatment to be generally safe, with most side effects being manageable. While some people may experience side effects, they are usually not severe and can often be treated without stopping the medication.

Overall, pembrolizumab has shown promising results in both effectiveness and safety for treating desmoplastic melanoma.12345

Why do researchers think this study treatment might be promising for melanoma?

Researchers are excited about pembrolizumab for desmoplastic melanoma because it leverages the power of immunotherapy. While traditional treatments often involve surgery, chemotherapy, or radiation, pembrolizumab is a monoclonal antibody that enhances the immune system's ability to recognize and destroy cancer cells. This treatment specifically targets the PD-1/PD-L1 pathway, which tumors use to hide from the immune system, making it a promising option for patients with unresectable or advanced forms of the disease. By potentially offering a less invasive and more targeted approach, pembrolizumab could represent a significant advancement in melanoma treatment.

What evidence suggests that pembrolizumab might be an effective treatment for desmoplastic melanoma?

Research shows that pembrolizumab effectively treats desmoplastic melanoma, a rare type of skin cancer. Studies have found that 89% of patients experienced a positive response, with tumors either shrinking or disappearing. Notably, 37% of patients saw their tumors completely vanish. This treatment aids the body's immune system in attacking and destroying cancer cells. In this trial, participants in Cohort A will receive pembrolizumab and may undergo surgery if their cancer is potentially resectable. Participants in Cohort B will receive pembrolizumab for unresectable disease. These strong results suggest that pembrolizumab could be a powerful option for people with desmoplastic melanoma, regardless of whether the cancer can be surgically removed.14567

Who Is on the Research Team?

KL

Kari L Kendra

Principal Investigator

SWOG Cancer Research Network

Are You a Good Fit for This Trial?

Adults with desmoplastic melanoma, a type of skin cancer, that can either be surgically removed or not. Participants must not have had prior treatments for this cancer or certain other therapies and drugs recently. They should not have active infections, autoimmune diseases needing recent treatment, or untreated brain metastases. Women who can bear children must test negative for pregnancy and agree to use contraception.

Inclusion Criteria

My medical center will send my samples for a special review.
COHORT B: Treating institution's identity must have current institutional review board approval for this study entered in the system
I haven't needed treatment for an autoimmune disease in the last 2 years.
See 38 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment (Cohort A)

Participants receive pembrolizumab intravenously every 21 days for up to 3 cycles, followed by surgery if disease is resectable

9 weeks
3 visits (in-person)

Treatment (Cohort B)

Participants with unresectable disease receive pembrolizumab intravenously every 21 days for up to 34 cycles

up to 2 years
34 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years
Every 12 weeks for the first year, then every 6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Pembrolizumab
Trial Overview The trial is testing pembrolizumab's effectiveness on resectable (can be removed by surgery) and unresectable (cannot be removed by surgery) desmoplastic melanoma. Pembrolizumab is an immunotherapy drug designed to help the immune system fight cancer cells. The study includes imaging tests like CT scans and may involve biopsies and collecting tissue samples.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Cohort B (pembrolizumab)Experimental Treatment6 Interventions
Group II: Cohort A (pembrolizumab, surgery)Experimental Treatment7 Interventions

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

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Approved in United States as KEYTRUDA for:
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Approved in European Union as KEYTRUDA for:
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Approved in United Kingdom as KEYTRUDA for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

Pembrolizumab (KEYTRUDA) was approved by the FDA for treating unresectable or metastatic melanoma based on two clinical trials involving 1,374 patients, showing significant improvements in overall survival compared to ipilimumab, with hazard ratios indicating a reduced risk of death.
Patients receiving pembrolizumab also experienced significant improvements in progression-free survival, although some immune-mediated adverse reactions like hypothyroidism and pneumonitis were noted, highlighting the importance of monitoring for side effects.
FDA Approval Summary: Pembrolizumab for the Treatment of Patients with Unresectable or Metastatic Melanoma.Barone, A., Hazarika, M., Theoret, MR., et al.[2022]
Pembrolizumab, a PD-1 inhibitor, has demonstrated clinical effectiveness in treating various solid tumors, particularly in patients with PD-L1-positive non-small-cell lung cancer and unresectable/metastatic melanoma.
Early-phase trials and ongoing studies are focused on further confirming the clinical benefits of pembrolizumab in thoracic malignancies, highlighting its potential as a significant treatment option in cancer therapy.
Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions.Karim, S., Leighl, N.[2017]
In a study of 183 patients with advanced melanoma treated with pembrolizumab, several baseline factors such as active brain metastases, higher total metabolic tumor volume (TMTV), and lower absolute lymphocyte count (ALC) were linked to worse survival outcomes.
TMTV was identified as a more effective predictor of treatment futility compared to other markers like C-reactive protein (CRP) and lactate dehydrogenase (LDH), suggesting that patients with high TMTV may not benefit from pembrolizumab therapy.
A Comprehensive Analysis of Baseline Clinical Characteristics and Biomarkers Associated with Outcome in Advanced Melanoma Patients Treated with Pembrolizumab.Awada, G., Jansen, Y., Schwarze, JK., et al.[2021]

Citations

Pembrolizumab Hits Nearly 90% Response Rate in ...Pembrolizumab showed an 89% objective response rate in unresectable desmoplastic melanoma, with a 37% complete response rate. The 3-year ...
Single-Drug Immunotherapy Shows Success in Rare Skin ...Pembrolizumab delivers 89% response rate in desmoplastic melanoma, sparing patients from harsher combination treatments.
Pembrolizumab Shows Exceptional Efficacy in Advanced ...Pembrolizumab Shows Exceptional Efficacy in Advanced Desmoplastic Melanoma · 37% complete response (CR) – full tumour disappearance. · 89% overall response rate ( ...
Pembrolizumab Alone to Treat Desmoplastic MelanomaIn that study, pembrolizumab or nivolumab alone shrank tumors in 38 of 56 (68%) patients, and 19 patients (32%) had complete responses.
Immunotherapy helps extend the lives of patients with rare ...The team found that 37% of patients had a complete response, meaning their tumors completely disappeared. Overall, 89% of patients experienced ...
Management of Cutaneous Melanoma, With a Special ...The 3-year melanoma specific survival was 96% (Table 1). There was no statistical difference in the benefit of neoadjuvant pembrolizumab between ...
Anti-PD-1 therapy in unresectable desmoplastic melanomaSecondary endpoints included progression-free survival (PFS), overall survival (OS) and evaluation of safety and tolerability of pembrolizumab ...
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