Italian Foundation started a clinical trial of Combination or Sequence of Vemurafenib, Cobimetinib, and Atezolizumab in High-risk, Resectable Melanoma
The Melanoma Foundation (Fondazione Melanoma Onlus) is commencing recruitment for the clinical trial of the Combination or Sequence of Vemurafenib, Cobimetinib, and Atezolizumab in High-risk, Resectable Melanoma.
The condition is Melanoma.
A new clinical trial is recruiting patients in the following locations: Italy.
The trial officially began on the October 12, 2020 and is planned to complete on June 2027.
Melanoma represents a considerable health burden and an ongoing area of unmet need in oncology. Despite melanoma accounts for only 1% of diagnosed skin cancers, it is the cause of most skin cancer-related deaths. Until recently, limited effective treatment options were available to patients with advanced melanoma. Historically, response rates to conventional chemotherapy and immunomodulation therapy (interleukin-2 or interferon-γ) have been reported at approximately 5-19%.
Adjuvant immune checkpoint blockade (ICB) and target therapy improve outcomes of patients with high-risk resectable melanoma. It has recently been demonstrated that treatment with neoadjuvant and adjuvant targeted therapy (dabrafenib and trametinib) is associated with a high pathologic complete response (pCR) rate and improved outcomes over surgery alone. However, treatment with ICB has not been well studied in the neoadjuvant setting, despite preclinical studies suggesting that neoadjuvant administration of ICB is associated with improved survival and enhanced anti-tumour immune responses compared to the same therapy administered in the adjuvant setting.
Neoadjuvant plus adjuvant treatment with target therapy and immunotherapy given in combination or sequence may have an anti-tumour activity and may reduce the risk of relapse in patients with high-risk resectable melanoma (stage III B / C / D and oligometastatic stage IV).
The advantage of neoadjuvant trials is the availability of blood and tumour tissue samples before and after systemic therapy for the conduct of novel mechanistic and biomarker studies in the circulation and the tumour microenvironment.
Among the criteria that allow participation, the following are indicated:
- Patients of either sex aged ≥18 yearsю
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent formю
- Patients must have histologically or cytologically confirmed Stage IIIB/C/D or oligometastatic stage IV1 resectable melanoma. The definition of resectability can be determined by the patient's surgical oncologist and verified via discussion at Multidisciplinary Tumour Conference attended by melanoma medical and surgical oncology staff. Resectable tumours are defined as having no significant vascular, neural or bony involvement. Only cases where a complete surgical resection with tumour-free margins can safely be achieved are defined as resectableю
- All patients must have a BRAF V600E/K mutation status knownю
- Absence of any psychological, familiar or social condition that may affect compliance with study protocol and schedule follow-up.
The full list can be viewed at the link below.
Clinical Research Technology S.r.l is the collaborator in this clinical trial.
The link to the complete study profile: https://ichgcp.net/clinical-trials-registry/NCT04722575
