Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of renal cell carcinoma, version 3.0
- Study type
- Clinical guideline
- Study name
- SITC RCC 2026
- Design
- Clinical guideline based on evidence review and expert panel consensus (modified Delphi method)
- Source
- J Immunother Cancer · 2026
In plain words
This guideline from the international Society for Immunotherapy of Cancer explains which patients with kidney cancer benefit from immunotherapy after surgery or in advanced disease, and which treatment is appropriate after immunotherapy stops working.
Key guideline recommendations
- LE:1
In patients with resected RCC who have pT2 with Fuhrman grade 4 or sarcomatoid differentiation, pT3 or higher, regional lymph node metastasis, or M1 with no evidence of disease, adjuvant pembrolizumab should be considered; treatment should start within 3 to 4 months of surgery and continue for 1 year.
- LE:1
For patients in whom immunotherapy is being considered, four regimens (nivolumab + ipilimumab; pembrolizumab + axitinib; nivolumab + cabozantinib; pembrolizumab + lenvatinib) have improved overall survival, and in the absence of head-to-head comparisons any of them is recommended.
- LE:1
In RCC with sarcomatoid features, ipilimumab + nivolumab is the preferred option.
- LE:3
In ICI-refractory metastatic RCC, a TKI-based regimen or (if previously treated with a TKI) belzutifan is recommended; if the patient has already received an ICI + TKI combination, a different TKI should be chosen. There is no proven role for sequential anti-PD-(L)1 regimens.
- Consensus
For relapse during or within 1 year of adjuvant pembrolizumab, there is no level 1 evidence for a standard treatment.
Study population
Patients with high-risk localised and advanced renal cell carcinoma for whom immunotherapy is being considered.
Endpoints
Recommendations required at least 85% expert panel consensus and are given with a level of evidence (LE) based on the Oxford criteria.
Clinical significance and place in guidelines
This version (2026) is the most recent specialist guideline on immunotherapy for RCC and takes into account the negative results of continuing immunotherapy after progression (CONTACT-03 and TiNivo-2) and the lack of an overall survival benefit for the triplet cabozantinib + nivolumab + ipilimumab (COSMIC-313).
Limitations
The recommendations are partly based on expert consensus and the guideline is limited to immunotherapy. The text of the recommendations is taken from the full text of the paper (open access).
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.