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T. Choueiri

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Open access Sep 2026

3 Safety Profile of Casdatifan Monotherapy in Patients with Clear Cell Renal Cell Carcinoma: Pooled Analysis of the ARC-20 Study (NCT05536141)

Abstract Background Hypoxia-inducible factor 2α (HIF-2α) is highly dysregulated in clear cell renal cell carcinoma (ccRCC), resulting in increased expression of proteins involved with angiogenesis, proliferation, and metastasis. Casdatifan is a potent, selective, orally bioavailable HIF-2α inhibitor that has demonstrat...

R. McKay, J. Merchan, A. Patnaik et al. · 0 citations
Open access Sep 2026

1 Pembrolizumab Plus Belzutifan Versus Pembrolizumab Plus Placebo as Adjuvant Therapy for Renal Cell Carcinoma: Patient-Reported Outcomes in LITESPARK-022

Abstract Background The randomized, double-blind, phase 3 LITESPARK-022 study (NCT05239728) showed significant disease-free survival benefit with the addition of belzutifan to adjuvant pembrolizumab in participants with clear cell renal cell carcinoma (ccRCC) at increased risk of recurrence following surgery. We presen...

T. Powles, T. Choueiri, J. Karam et al. · 0 citations
Open access Sep 2026

72 Time-of-day of Immune Checkpoint Inhibitor Infusion and Overall Survival in Renal Cell Carcinoma: A Real-World Cohort Analysis

Abstract Background Previous retrospective work found an association between earlier immune-checkpoint inhibitors (ICI) infusion times and survival outcomes in renal cell carcinoma (RCC). A recent randomized trial in non-small cell lung cancer (NSCLC) also reported benefit, however, a recent analysis of several randomi...

P. Barrios, Mustafa Saleh, Liliana Ascione et al. · 0 citations
Open access Sep 2026

11 Long-Term Follow-Up from the OMNIVORE Trial: Response-Adaptive Nivolumab and Ipilimumab in Advanced Renal Cell Carcinoma (NCT03652142)

Abstract Background Immune checkpoint inhibitor-based combinations represent the standard of care for advanced renal cell carcinoma (RCC). The OMNIVORE trial (NCT03652142) investigated a response-adaptive strategy including treatment discontinuation in early nivolumab responders (Arm A) and salvage ipilimumab addition...

M. Serzan, Wan-Ling Xie, B. McGregor et al. · 0 citations
Open access Sep 2026

70 Lymphocyte Hsp70 is a Novel Predictive Biomarker for Response to Immune Checkpoint Inhibitors in Metastatic Renal Cell Carcinoma

Abstract Background We sought to map the immunological landscape of metastatic renal cell carcinoma (RCC) in order to understand the mechanisms that dictate response to immune checkpoint inhibitors (ICI) and uncover biomarkers for ICI response. Methods We generated a single-cell RNA sequencing (scRNA-seq) atlas of the...

Ethan C. Burns, S. Kashima, Rishabh Rout et al. · 0 citations
Open access Oct 2026

Pharmacologic HIF-2α inhibition preserves T cell effector function in clear cell renal cell carcinoma.

Hypoxia-inducible factor 2α (HIF-2α) is a central oncogenic driver in clear cell renal cell carcinoma (ccRCC) and a therapeutic target of the small-molecule inhibitor belzutifan. Genetic studies in murine models have suggested that hypoxia signaling may support T cell effector programs, raising concern that HIF-2α inhi...

Katrine N. Madsen, S. Kashima, H. Soulati et al. · 0 citations
Sep 2026

Spatially confined IL-12 programs CAR-NK through mTORC1 to coordinate antitumor immune networks.

Solid tumors evade immunotherapy because of immunosuppressive microenvironments that limit immune cell persistence and function. Although interleukin-12 (IL-12) potently activates antitumor immunity, its clinical use has been constrained by systemic toxicity. Here we engineered a CAR natural killer (NK) cell platform t...

Mubin Tarannum, K. Dinh, Mila Stanojevic et al. · 0 citations
Open access Aug 2026

Adjuvant pembrolizumab for the treatment of clear cell renal cell carcinoma: Five-year results from the phase III KEYNOTE-564 study.

BACKGROUND The randomized phase III study KEYNOTE-564 (NCT03142334) established pembrolizumab after surgery as the standard of care for patients with clear cell renal cell carcinoma (ccRCC) at increased risk of recurrence. Prior analyses showed significantly improved disease-free survival (DFS) and overall survival (OS...

N. Haas, T. Powles, P. Tomczak et al. · 1 citation
Review Open access Sep 2026

85 Phase 3 LITESPARK-033 (NCT07227402) Study of Belzutifan Plus Zanzalintinib Versus Cabozantinib for Recurrent Clear Cell Renal Cell Carcinoma During or After Adjuvant Anti–PD-(L)1 Therapy

A randomized, multicenter, open-label phase 3 LITESPARK-033 study is designed to evaluate the efficacy and safety of belzutifan plus zanzalintinib versus cabozantinib in participants with advanced clear cell RCC who experienced recurrence during or after anti–PD-(L)1 adjuvant therapy.

T. Choueiri, T. Powles, M. Voss et al. · 0 citations
Review Open access Sep 2026

88 PEAK-1 (NCT07011719): A Randomized, Double-Blind, Active-Control Phase 3 Trial of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients with Advanced Clear Cell Renal Cell Carcinoma

Abstract Background For patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have relapsed after anti-programmed death protein 1 (anti–PD-1) or anti-programmed death ligand-1 (anti–PD-L1) treatment, second-line treatment options remain limited, consisting primarily of tyrosine kinase inhibit...

T. Choueiri, S. Pal, R. McKay et al. · 0 citations
Open access Sep 2026

54 Primary Progressive Disease and Outcomes with First-Line Nivolumab Plus Ipilimumab in Metastatic Renal Cell Carcinoma: A Real-World IMDC Analysis

Abstract Background Nivolumab plus ipilimumab (NIVO+IPI) combination therapy is a first-line standard in metastatic renal cell carcinoma (mRCC). Despite durable responses in some patients, over 20% develop primary progressive disease (PPD) at first restaging imaging. In this study, we evaluated clinical factors associa...

É. Ibrahim, Wan-Ling Xie, R. El Hajj Chehade et al. · 0 citations
Open access Sep 2026

43 DSG2 and NPNT are Elevated in the Plasma of Metastatic Chromophobe RCC and are Associated with Poorer Overall Survival

Abstract Background Chromophobe renal cell carcinoma (ChRCC) is traditionally defined by its unique metabolic reprogramming, including an increase in mitochondrial mass. The mitochondrial plasma proteome of metastatic ChRCC has been recently reported (Steiner et al. Cancers 2026), and we defined a two-protein signature...

Tie-Gang Han, Clara Steiner, Steven Safi et al. · 0 citations

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