Professional Standards

Cancer Immunotherapy Guidelines Program

The SITC Cancer Immunotherapy Guidelines (CIG) 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. SITC CPGs distill the published literature and the best clinical judgment of the expert panel into practical, actionable recommendations to help cancer care providers develop immunotherapy treatment plans for their patients. SITC has 16 different CPGs covering a variety of hematologic malignancies, solid tumors, and toxicity management.

Clinical Practice Guidelines

SITC CPG topics and features:

Recommended therapies and treatment algorithms
Diagnostics and biomarkers
Monitoring response to treatment
Toxicity management
Patient education and quality of life considerations
Special patient populations
Emerging agents

2024 CPG Living Guidelines Rapid Updates

SITC Living Guideline rapid update protocols are designed to ensure SITC’s clinical practice guidelines are up to date with cutting-edge thinking and incorporate the leading expert guidance in cancer immunotherapy care. Through the use of innovative technology, rapid updates are swiftly integrated into our existing published guidelines in a clear and concise manner. An overlay system highlights affected content and provides new text reflecting the updated Expert Panel guidance as well as important supporting information, data, and references. These rapid updates show the progression of the changes by using a version numbering system and last reviewed date that accompanies each new posted update.

In 2024, SITC published seven updates to our existing guidelines including:

  • Head and Neck Squamous Cell Carcinoma CPG v1.1, updated 11/15/24
  • Urothelial Cancer CPG v2.4, updated 10/19/24
  • Melanoma CPG v3.1 and v 3.2, last updated 9/20/24
  • Gynecologic Cancer CPG v1.1, updated 5/25/24
  • Nonmelanoma Skin Cancer CPG v1.1, updated 3/19/24
  • Breast Cancer CPG v1.2, updated 3/15/24

CPG Mobile App

AAMSE’s 2024 President’s Award Recipient

The SITC CPG Mobile App has been honored with the 2024 President’s Award from the American Association of Medical Society Executives (AAMSE). This is the highest honor bestowed by AAMSE each year as part of their Profiles of Excellence (PoE) Award Program that recognizes organizations for their efforts to advance the field of medicine and improve the lives of physicians and the patients they serve.

Named a “Best App” by Genetic Engineering & Biotechnology News

The CPG Mobile App has received a rating of "Excellent" by Genetic Engineering & Biotechnology News (GEN), earning a spot in its "Best Apps" category. GEN attributes this ranking to the app’s wide range of resources and interactive tools, and its well-organized, user-friendly design.

CPG Companion Education

SITC offers free, on-demand educational webinars and mini-modules for published SITC CPGs. These resources provide information intended to enhance understanding of the clinical recommendations and treatment algorithms included in the SITC CPGs as well as provide practical experience through case studies examples.

Certificate in Cancer Immunotherapy

SITC offers physicians and qualified healthcare providers the only opportunity to earn a Certificate in Cancer Immunotherapy, supporting their knowledge and skills to provide effective and safe cancer immunotherapy treatment for patients. Learners can develop a comprehensive understanding of cancer immunotherapies, including checkpoint inhibitors, cell therapies and many others, as well as the management of side effects, allowing them to successfully implement immunotherapy in clinical practice.

234 learners registered for the SITC-G in 2024

To date, 146 people have completed the SITC-G

Learn more: sitcancer.org/certificate

Intratumoral Immunotherapy Clinical Trials (IICT) Consensus Statement

Published in April 2024, the new manuscript, “Society for Immunotherapy of Cancer (SITC) recommendations on intratumoral immunotherapy clinical trials (IICT): from premalignant to metastatic disease” aims to provide guidance on how to design trials with the greatest likelihood of demonstrating the benefits of intratumoral immunotherapy across all stages of pathogenesis, and ultimately bring more effective treatment options to patients. Key elements discussed include patient stratification factors, exclusion criteria, study arm considerations, optimal endpoints, response assessment, and patient populations to prioritize.

PATHdata Research

The Pan-tumor harmonization of pathologic response assessment for standardized data collection in neoadjuvant IO trials (PATHdata) project continues to move forward. Thus far, we have completed the multi-institutional reproducibility study, the interim analysis of the data, and the post-scoring survey of the participating pathologists. High reproducibility amongst pathologists was observed using irPRC scoring (overall intraclass correlation coefficient, ICC [95% confidence Interval]: 0.88 [0.79-0.94]). These results were presented at ASCO and SITC as late-breaking abstracts. As the study leads work to complete the accompanying manuscripts and update the training materials to reflect the pathologist feedback, we’ve had initial discussions with CAP and AJCC about incorporating a pan-tumor approach within their reporting systems. In addition, Dr. Neil Gross (MD Anderson) has asked to utilize the training materials in an upcoming trial: NRG-HN014: Randomized Phase III Trial of Neoadjuvant Immunotherapy with Response-Adapted Treatment Versus Standard-Of-Care treatment For Resectable Stage III/IV Cutaneous Squamous Cell Carcinoma. We are currently developing a survey to keep track of how many pathologists from the study utilize the training materials and implement the pan-tumor approach.

IO Surrogate Endpoints Consensus Effort

The discovery of effective novel surrogate endpoints is critical to increase the quality, quantity, and speed of which novel therapies can gain accelerated approval through clinical trials. As such, on April 5, 2024, led collaboratively by the SITC Biomarkers Committee and Regulatory Subcommittee, SITC held the Surrogate Endpoints Virtual Summit. 

SITC invited 59 experts across the field of immunotherapy to discuss the science behind surrogate endpoints and identify potential endpoints worth pursuing. Five working groups were created focusing on the role of:  

  • IO Endpoints
  • Deep Response Rate
  • Pathologic Evaluation
  • ctDNA
  • Imaging

The results of the summit have been drafted into an executive summary and the summary was marketed to the field with an open call for comment survey. The summary and the results of the survey are being used to facilitate the development of a consensus-level manuscript detailing field-wide recommendations with the intention to have continued discussions with the FDA. The manuscript is currently under development with an intended publication in late 2025. View the executive summary here.

Essential Biomarkers Commentary and Consensus Manuscript

With the aim of proposing a framework for the prioritization of biomarker studies in immunotherapy clinical trials, in March of 2024, a commentary on categorizing biomarkers for clinical development was published in the Journal for ImmunoTherapy of Cancer (JITC).

This publication was then used as the basis for a Delphi survey of SITC members, the SITC Clinical Immuno-Oncology Network (SCION) faculty, the Pathology and Biomarker Committees of SITC, and the readership of JITC. Based on the feedback provided by this survey, as well as rapid development across the field, the commentary authors have developed and fleshed out updated definitions by listing "essential" biomarkers that they believe should be included in all immunotherapy protocols. These essential biomarkers will be detailed in a forthcoming, consensus-level publication that is currently in development. The manuscript is intended to be published in JITC in January of 2025. The manuscript authors plan to update the manuscript on an annual basis as the field continues to evolve.

Read the commentary in JITC.