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Experts break down the clinical trial data and regulatory developments that made 2025 a “remarkable year” in kidney and bladder cancer management.

Experts highlight considerations for treating patients with oligometastatic kidney cancer, such as differentiating between de novo and recurrent disease.

A first-in-human phase 1/2 trial is evaluating the theranostic pair of ITM-91 and ITM-94 in patients with solid tumors.

Pembrolizumab plus belzutifan is the first combination therapy to improve DFS vs pembrolizumab monotherapy in the adjuvant treatment of those with RCC.

Belzutifan/lenvatinib also showed a favorable trend toward improvement for overall survival in this advanced renal cell carcinoma population.

Data from the FRUSICA-2 trial may support fruquintinib/sintilimab as a “valuable” option for patients with advanced renal cell carcinoma.

Casdatifan, administered at 100 mg once daily, achieved a confirmed ORR of 35% in patients with pretreated metastatic kidney cancer.

Ongoing studies in kidney cancer aim to explore determinants of immune-related adverse effects and strategies for mitigating them.

Machine learning–based approaches may play a role in further understanding of how somatic alterations influence responses or resistance to therapy.

Data from a first-in-disease trial assessing a personalized cancer vaccine in RCC require validation at a larger level, according to David Braun, MD, PhD.

Changes in FKSI-15 scores from baseline indicated more favorable HRQOL outcomes with the benmelstobart combo vs sunitinib in advanced ccRCC.

External validation will be assessed in cohort 2 of the AURORAX-0087A trial to improve recurrence detection for clear cell renal cell carcinoma.

Additional correlative data and further prospective clinical investigations are needed to inform biomarker-directed advanced RCC treatment.

The biomarker analysis in KEYNOTE-426 showed that pembrolizumab plus axitinib therapy is associated with positive outcomes with angiogenesis in RCC.

Data from the LITESPARK-005 Q-TWiST analysis show belzutifan’s improved quality-adjusted survival time and favorable toxicity profile vs everolimus in RCC.

Improving data collection and biomarker development across institutions may represent areas of expansion in kidney cancer research.

KIM-1 is a biomarker in the blood that may help noninvasively detect kidney cancer, according to Wenxin (Vincent) Xu, MD.

Experts share their perspectives on updated clinical trial results, personalized cancer vaccine research, and other notable developments in kidney cancer.

A phase 0 trial is seeking to assess the feasibility of aiding anticancer cells with cytokines to restore their function.

Although pembrolizumab addressed a long-standing need in adjuvant kidney cancer treatment, combinations with the agent may further bolster efficacy.
![“The trial will be successful, or [we’ll] declare it a success if we see at least 3 of 24 responses overall,” stated Ravi, MD, BChir, MRCP, on the phase 2 LASER trial in RCC.](https://cdn.sanity.io/images/0vv8moc6/cancernetwork/9addaac21d809a7b642a567b0a704cbb15d87ac5-2966x1684.png?w=350&fit=crop&auto=format)
“The trial will be successful, or [we’ll] declare it a success if we see at least 3 of 24 responses overall,” stated Praful Ravi, MB, BChir, MRCP, on the phase 2 LASER trial in RCC.

Success with the 177Lu-PSMA-617 radioligand therapy would be transformative for the clear cell renal cell carcinoma treatment landscape.

Personalized kidney cancer vaccines may help guide immune therapies to more effectively attack cancerous cells while mitigating harm to healthy tissue.

Collaborators in the Kidney Cancer Research Consortium aim to address mechanistic and scientifically driven questions in the kidney cancer field.

A genitourinary oncologist explained that KIM-1 can be used to diagnose, risk-stratify, and detect disease and monitor disease treatment in patients with kidney cancers.









![“As a community, if we’re looking to help enroll and advocate for patients with rare [kidney cancers], we need to be aware of what is out there,” said A. Ari Hakimi, MD.](https://cdn.sanity.io/images/0vv8moc6/cancernetwork/a69f69efca1ade2e100fbb9cdf798d49ea5a0f94-2966x1684.png?w=320&fit=crop&auto=format)




























































