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New treatment option for Melanoma (Skin Cancer)
Official title Neoadjuvant Pembrolizumab in Patients With Stage IIb/c Melanoma
ClinicalTrials.gov ID: NCT07349303
What this study is testing
What is Pembrolizumab?
Pembrolizumab is an investigational medicine, being studied as a potential treatment for melanoma (skin cancer).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A phase II double-blind placebo-controlled randomized trial. Patients with a clinical suspicion of a thick primary melanoma without clinical suspicion or evidence of lymph-node engagement will undergo a 3 mm punch biopsy to verify the diagnosis and ascertain eligibility.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patient is ≥18 years.
- Signed informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Histopathologically confirmed primary cutaneous melanoma stage IIb/c (Breslow \>2.0 mm with ulceration OR Breslow \>4.0mm without ulceration) with a...
- Patient planned for wide local excision and sentinel lymph node biopsy
You likely can't join if
- Life expectancy of less than 3 years.
- Patients who are unable to undergo general anesthesia for any reason.
- Clinical or radiographic evidence of nodal, satellite, in-transit or distant metastases
- Risk for developing in-operable disease due to study procedures as judged by study investigator
- Prior immunotherapy for any malignancy
- Use of live vaccines four weeks before or after the last study treatment.
See the full eligibility criteria
- Patient is ≥18 years.
- Signed informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Histopathologically confirmed primary cutaneous melanoma stage IIb/c (Breslow \>2.0 mm with ulceration OR Breslow \>4.0mm without ulceration) with a minimum diameter of 5 mm not completely removed by the diagnostic...
- Patient planned for wide local excision and sentinel lymph node biopsy
- Adequate organ function on blood test
- Female patient of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first treatment. If the urine test is positive or cannot be confirmed as negative, a...
- Female patients of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 150 days after the last dose of study medication. Note: Abstinence is acceptable...
- Male patients of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 150 days after the last dose of study therapy. Abstinence is...
- Life expectancy of less than 3 years.
- Patients who are unable to undergo general anesthesia for any reason.
- Clinical or radiographic evidence of nodal, satellite, in-transit or distant metastases
- Risk for developing in-operable disease due to study procedures as judged by study investigator
- Prior immunotherapy for any malignancy
- Use of live vaccines four weeks before or after the last study treatment.
- History of severe reactions to monoclonal antibodies.
- Active autoimmune disease or a documented history of autoimmune disease requiring systemic immunomodulatory treatment. Diabetes, rheumatoid arthritis, psoriasis, atopic dermatitis and hypothyroidism are excepted.
- A condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids...
- Concomitant therapy with any other anti-cancer therapy, concurrent medical conditions requiring use of immunosuppressive medications or use of other investigational drugs.
- Has a known additional malignancy that is progressing or requires active treatment.
- Pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 150 days after the last dose of study drug.
- A history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not...
The study team makes the final eligibility decision.
Where it's taking place
- Gothenburg, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gothenburg, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.