SITC Melanoma Immunotherapy Guideline

SITC's Cancer Immunotherapy Guidelines program is a collection of clinical practice guidelines (CPGs) developed by multi-disciplinary panels of experts who draw from their own practical experience as well as evidence in the published literature and clinical trial data to develop evidence- and consensus-based recommendations. SITC uses as a model the Institute of Medicine's 2011 "Standards for Developing Trustworthy Clinical Practice Guidelines" to ensure recommendations are unbiased, transparent, and balanced.

The recommendations in this guideline provide a valuable clinical decision-making tool to help guide oncologists and other advanced practice providers with selection of appropriate immunotherapeutic regimens, diagnostics and biomarker testing, and patient quality of life considerations.

Published Guideline

READ GUIDELINE

Updated Content (last reviewed 9/20/24)
In accordance with the Institute of Medicine’s Standards for Developing Trustworthy Clinical Practice Guidelines, SITC CPGs undergo periodic evaluation to assess if new evidence necessitates modifications to recommendations, treatment algorithms, or other guideline content. This is done through our “SITC Living Guidelines” rapid update protocols designed to ensure SITC CPGs are up-to-date with cutting-edge thinking and incorporate the leading expert guidance in cancer immunotherapy care – a vital service to treating clinicians and those along the whole cancer care continuum.

The information below provides an overview of updates made to the "Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of melanoma, version 3.0" published in Journal for ImmunoTherapy of Cancer (JITC).

Addendum v3.2 Summary

An addendum to the SITC Melanoma v3.0 CPG is now available. This addendum integrates prior rapid updates with practice-changing data and approvals. The SITC Melanoma CPG Expert Panel has updated the recommendations in this guideline to address the following:

On October 13, 2023, the US Food and Drug Administration (FDA) granted approval to nivolumab for the treatment of resected stage IIB/C melanoma in the adjuvant setting for patients 12 and older. Approval of nivolumab in this setting was based on significant improvement of recurrence-free survival (RFS) in the phase III CheckMate 76K trial(NCT04099251), which enrolled patients with completely resected stage IIB/C melanoma.
On February 16, 2024, the US FDA granted an accelerated approval to lifileucel for the treatment of unresectable or metastatic melanoma in adult patients who have been previously treated with a programmed cell death protein 1 (PD-1) blocking antibody, and if BRAFV600 positive, a BRAF inhibitor (BRAFi) with or without a MEK inhibitor (MEKi). Lifileucel is a first of its kind autologous tumor-infiltrating lymphocyte (TIL) cell therapy.
Practice-changing data demonstrating the efficacy of neoadjuvant nivolumab and ipilimumab followed by surgery in patients with resectable stage III melanoma were reported from the NADINA trial (NCT04949113). The phase III randomized trial assessed neoadjuvant nivolumab and ipilimumab followed by surgery (with adjuvant therapy for those with a partial or non-response) compared to adjuvant nivolumab in patients with resectable stage III melanoma showed longer event-free survival (EFS) with the neoadjuvant regimen.

Rapid Update v3.1 Summary

The FDA granted accelerated approval to lifileucel (autologous tumor-infiltrating lymphocyte therapy) for adult patients with unresectable or metastastic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 positive a BRAF inhibitor with or without a MEK inhibitor in February 2024. Based on this approval, the Melanoma v3.0 CPG has been updated in the following locations: "Stage IV cutaneous melanoma – Patients with CNS Disease," "Stage IV cutaneous melanoma – Available agents and indications for previously-treated disease," and "Special patient populations - Patients with non-cutaneous melanoma."

Download the app for quick access to the melanoma CPG with interactive tools and companion education resources.

Guideline Education

SITC is pleased to offer companion education resources in support of the gastrointestinal cancer CPG. These activities feature faculty comprised of the guideline expert panel and are designed to provide a deeper understanding of the recommendations in the SITC guidelines and how to apply them in various clinical scenarios. The education available features one-hour webinars, available free and on-demand, that take a deeper look at the guideline recommendations.

Practical Management Pearls for Immunotherapy for the Treatment of Melanoma

This one hour on-demand webinar features members of the guideline Expert Panel. These faculty members discuss how to appraise and classify organ-specific considerations for immunotherapy agents and toxicities, identify and manage clinically significant uncommon toxicities, and determine optimal sequencing of immunotherapies in relapsed and/or refractory disease.

Case Studies in Immunotherapy for the Treatment of Melanoma

This one hour on-demand webinar features members of the guideline Expert Panel. These faculty members discuss case studies that illustrate execution of SITC guideline recommendations, as well as discussion on difficult topics related to case management.

For questions regarding the SITC CPGs, please contact a member of the Scientific Publications Department at scientificresources@sitcancer.org.

SITC Melanoma Immunotherapy Guideline

Published Guideline

Guideline Education

Contact

Phone

Popular Links

Community Links

Legal