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New treatment option for Melanoma (Skin Cancer)
Official title A Phase II Clinical Trial on Neo-adjuvant Pembrolizumab in Patients With pT3b-T4a/b cN0M0 Melanoma.
ClinicalTrials.gov ID: NCT07448831
What this study is testing
What is Pembrolizumab?
Pembrolizumab is an investigational medicine, given as an infusion into a vein, 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
- This study, called NeoSenti, is exploring whether giving one dose of the immunotherapy drug pembrolizumab before surgery can help the immune system fight melanoma more effectively. The study includes adults with high-risk melanoma who do not show any signs of the cancer having spread on scans.
- Phase 2: a mid-size study of how well it works
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
- ≥ 18 years of age on the day of signing the informed consent. Histologically confirmed high risk primary cutaneous pT1b-4b melanoma High risk primary...
- pT1b-3a, with a poor prognostic score on the Merlin™ test ("Merlin™ high risk");
- pT3b-4b, irrespective of their Merlin™ test result Amendable to sentinel lymph node biopsy. No evidence of metastatic dissemination as demonstrated...
- Female patients must be surgically sterile or be postmenopausal (A postmenopausal state is defined as no menses for 12 months without an alternative...
- If a female patient is a woman of childbearing potential (WOCBP) they must agree to use highly effective contraception measures during the period of...
You likely can't join if
- Patients with uveal melanoma, mucosal melanoma and melanoma of unknown primary origin.
- 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...
- Known Human Immunodeficiency Virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection. Exception: people with laboratory evidence...
- Any serious or unstable pre-existing medical conditions (aside from malignancy exceptions specified above), psychiatric disorders, or other...
- Active infection at the time of screening (e.g. wound infection).
See the full eligibility criteria
- ≥ 18 years of age on the day of signing the 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 Amendable to sentinel lymph node biopsy. No evidence of metastatic dissemination as demonstrated by PET/CT, ultrasound of the draining lymph node basin, and clinical...
- Female patients must be surgically sterile or be postmenopausal (A postmenopausal state is defined as no menses for 12 months without an alternative medical cause).
- If a female patient is a woman of childbearing potential (WOCBP) they must agree to use highly effective contraception measures during the period of therapy, which should be continued for at least 4 months following the...
- Should not be breastfeeding at screening or during study treatment. Men with a female partner of childbearing potential must agree to use highly effective contraception from 14 days prior to administration of the first...
- Patients with uveal melanoma, mucosal melanoma and melanoma of unknown primary origin.
- 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...
- Known Human Immunodeficiency Virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection. Exception: people 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...
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Jette, Brussels Capital, Belgium
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 Jette, Brussels Capital, Belgium. 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.