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A phase 2 clinical trial on neoadjuvant pembrolizumab in patients diagnosed with high-risk melanoma without clinical evidence of metastatic dissemination.
EU CTIS ID: 2024-517840-68-00
What this study is testing
To estimate the antitumor activity of pembrolizumab in high-risk primary cutaneous melanoma population (pT1b to pT4b) without clinical evidence of metastasis (cN0M0) in the neoadjuvant setting.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- ≥18 years of age on the day of signing informed consent.
- Capable of providing documented informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. Participants (or legally acceptable representative) must provide documented informed consent
- Histologically confirmed high risk primary cutaneous pT1b-4b melanoma. High risk primary melanoma is defined in this study as the following AJCC8 T-stages: • pT1b-3a, with a poor prognostic score on the Merlin™ test (“Merlin™ high risk”); • pT3b-4b, irrespective of their Merlin™ test result
- Amenable to sentinel lymph node biopsy.
- No evidence of metastatic dissemination as demonstrated by PET/CT, ultrasound of the draining lymph node basin, and clinical examination.
- No prior exposure to systemic treatment for melanoma.
You likely can't join if
- Patients with uveal melanoma and melanoma of unknown primary origin.
- Prior transplantation of human cells, tissues and organs (e.g. liver transplant) or candidates for any type of transplantation.
- History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient’s participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.
- Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Any contra-indication for evaluation by whole body 18F-FDG-PET/CT or MRI.
- Active autoimmune disease requiring systemic treatment
See the full eligibility criteria
Who can join
- ≥18 years of age on the day of signing informed consent.
- Capable of providing documented informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. Participants (or legally acceptable representative) must provide documented informed consent
- Histologically confirmed high risk primary cutaneous pT1b-4b melanoma. High risk primary melanoma is defined in this study as the following AJCC8 T-stages: • pT1b-3a, with a poor prognostic score on the Merlin™ test (“Merlin™ high risk”); • pT3b-4b, irrespective of their Merlin™ test result
- Amenable to sentinel lymph node biopsy.
- No evidence of metastatic dissemination as demonstrated by PET/CT, ultrasound of the draining lymph node basin, and clinical examination.
- No prior exposure to systemic treatment for melanoma.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1 or 2 assessed within 7 days prior to the first dose of study treatment.
- Adequate organ function as defined: Absolute neutrophil count ≥ 1.2 x 103/mm3, Hemoglobin ≥ 9.0 g/dL, Platelet count ≥ 75 x 103/mm3, Total bilirubin ≤ 1.5 x ULN, ALT ≤ 2.5 x ULN, Calculated creatinine clearance ≥ 50 mL/min). Specimens must be collected within 7 days prior to the start of study treatment.
- Women: a. Not a woman of childbearing potential (WOCBP) b. Women of childbearing potential must have a negative serum pregnancy test during screening and within 72 hours prior to treatment initiation and agree to use effective contraception of their choice throughout the treatment period, and for 16 weeks after the last dose of study treatment. c. Women who are not breastfeeding
- Men with a female partner of childbearing potential must agree to use effective contraception from 14 days prior to administration of the first dose of study treatment or have either had a prior vasectomy, throughout the treatment period, and for 16 weeks after the last dose of study treatment.
What rules you out
- Patients with uveal melanoma and melanoma of unknown primary origin.
- Prior transplantation of human cells, tissues and organs (e.g. liver transplant) or candidates for any type of transplantation.
- History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient’s participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.
- Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Any contra-indication for evaluation by whole body 18F-FDG-PET/CT or MRI.
- Active autoimmune disease requiring systemic treatment
- Patients with a history of previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: gastric, colon, cervical/dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 3 years prior to screening and no additional therapy is required or anticipated to be required during the study period.
- Known Human Immunodeficiency Virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection. Exception: subjects with laboratory evidence of cleared HBV and HCV infection will be permitted.
- Any serious or unstable pre-existing medical conditions (aside from malignancy exceptions specified above), psychiatric disorders, or other conditions that could interfere with the subject’s safety, obtaining informed consent, or compliance with study procedures.
- Active infection at the time of screening (e.g. wound infection)
- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study treatment, or excipients
- History of organ allograft.
- Patients who have previously been exposed to checkpoint inhibitors
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.