Renal Cell Carcinoma
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Jul 20 – Jul 27, 2026
Safety and efficacy of fecal microbiota transplantation in solid cancers resistant to immune checkpoint inhibitors: results of the MITRIC trial.
J IMMUNOTHER CANCER · Q1 JOURNAL - RANK #12/183TOP-TIER
This single-arm phase IIa basket trial (MITRIC; NCT05286294) tested the safety, feasibility, and efficacy of fecal microbiota transplantation (FMT) from immune checkpoint inhibitor (ICI) responders to patients with advanced cancers refractory to ICIs. Patients received up to five FMT administrations in combination with ICIs, with FMT-related adverse events and objective response as co-primary endpoints. Among 12 participants with various solid tumors, no objective responses were observed, five achieved stable disease, and median progression-free survival and overall survival were 1.5 and 10.1 months, respectively. Although FMT plus ICIs proved safe and feasible, clinical activity was limited, highlighting the need for further studies.
10.1136/jitc-2026-015122
Jul 13 – Jul 20, 2026
Allogeneic CD70-Targeted Chimeric Antigen Receptor T-Cell Therapy for Advanced Renal Cell Carcinoma: Results From the Phase I TRAVERSE Trial.
J CLIN ONCOL · Q1 JOURNAL - RANK #6/326TOP-TIER
The phase Ia/b TRAVERSE trial prospectively assessed safety, tolerability and preliminary efficacy of ALLO-316, an allogeneic CD70-targeted CAR T-cell therapy, in adults with advanced clear-cell renal cell carcinoma resistant to immune checkpoint and VEGFR-targeted therapies. Using a modified 3 + 3 design, 51 patients received fludarabine/cyclophosphamide lymphodepletion with or without the anti-CD52 antibody ALLO-647, followed by escalating doses of ALLO-316; phase Ib confirmed the recommended regimen of FC plus 80 × 10⁶ CAR T cells. After a median 28.8-month follow-up, two dose-limiting toxicities (grade 3 autoimmune hepatitis; grade 5 cardiogenic shock) occurred, grade ≥3 cytokine release syndrome in 2%, neurotoxicity in 0%, and hemophagocytic lymphohistiocytosis-like syndrome in 6%, with hematologic toxicities (neutropenia 62%) predominating. Objective response rate was 17.4% overall, 25.0% in phase Ib, and 31.3% among tumors with CD70 ≥50%. Investigators conclude ALLO-316 shows manageable safety and promising antitumor activity, supporting further development of off-the-shelf CAR T-cell therapy for solid tumors.
10.1200/JCO-26-00388
Jul 06 – Jul 13, 2026
Adjuvant penpulimab in very-high risk clear cell renal cell carcinoma: a prospective, non-randomized, controlled phase II trial with integrated plasma multi-omics analyses.
J IMMUNOTHER CANCER · Q1 JOURNAL - RANK #12/183TOP-TIER
This multicenter, prospective, non-randomized controlled phase II trial investigated whether adjuvant penpulimab improves outcomes in 174 patients with very-high-risk clear cell renal cell carcinoma after nephrectomy. After 1:1 propensity score matching, 87 patients received penpulimab and 87 underwent routine surveillance; disease-free survival (DFS) was the primary endpoint, with overall survival (OS), safety, and plasma proteomic/metabolomic biomarkers as secondary or exploratory endpoints. Penpulimab prolonged DFS versus surveillance (hazard ratio 0.37, 95% CI 0.16–0.89, p = 0.026), with 1-year and 2-year DFS rates of 94.3% and 88.7% compared with 80.5% and 75.4%, respectively; OS data were still immature. Most adverse events were grade 1–2, and multi-omics analyses highlighted immune-response pathways and circulating biomarkers associated with reduced progression, supporting penpulimab as a promising adjuvant therapy that warrants further validation.
10.1136/jitc-2026-015686
Dynamic immune profiling predicts response to radiation plus anti-PD-1 therapy in oligometastatic renal cell carcinoma.
NAT COMMUN · Q1 JOURNAL - RANK #10/135TOP-TIER
The RAPPORT trial was a prospective phase I/II study of stereotactic ablative body radiotherapy (SABR) combined with pembrolizumab in 30 patients with oligometastatic clear cell renal cell carcinoma. The primary endpoint was safety, and secondary endpoints were overall survival, time to local progression, distant progression-free survival, objective/disease control rates, duration of response, and pain outcomes. Pre-treatment analyses indicated that responders exhibited elevated intra-tumoural cytotoxic T cell infiltration, while non-responders demonstrated immunosuppressive and angiogenic signatures; post-treatment, responders showed bursts of activated CD8 T cells and sustained tumour-enriched T cell receptor clones. The trial suggests that trafficking and maintenance of pre-existing tumour-specific T cells predict improved responses to SABR plus anti-PD-1 therapy.
10.1038/s41467-026-74255-x
Jun 29 – Jul 06, 2026
Evaluation and analysis of renal injury in patients with advanced renal cell carcinoma receiving first-line benmelstobart plus anlotinib: results from the ETER100 study.
BMC MED · Q1 JOURNAL - RANK #19/332
This post hoc analysis of the randomized ETER100 trial (NCT04523272) evaluated treatment-emergent renal injury and its prognostic implications in advanced RCC patients receiving first-line benmelstobart plus anlotinib versus sunitinib. Among all randomized patients treated with at least one dose, investigators compared incidences of serum creatinine elevation, creatinine clearance declines, and proteinuria, identified risk factors, and assessed associations with PFS/OS using multivariable models. The combination did not increase renal injury versus sunitinib (serum creatinine elevation p=0.0538; creatinine clearance % decrease p=0.2546; absolute decrease p=0.7343; proteinuria p=0.0728); nephrectomy history and eGFR <90 mL/min/1.73 m^2 predicted creatinine rises. Renal abnormalities frequently resolved (creatinine elevation recovered 64% [64/100], improved 6%; proteinuria recovered 45.56% [77/169], improved 22.49% [38/169]) and were not independent risk factors for PFS (p=0.3526/0.5831) or OS (p=0.0521/0.1224).
10.1186/s12916-026-05026-0
Adjuvant Pembrolizumab plus Belzutifan for Renal-Cell Carcinoma.
NEW ENGL J MED · Q1 JOURNAL - RANK #2/332TOP-TIER
This phase 3, double-blind, randomized clinical trial (LITESPARK-022, NCT05239728) assessed whether adding the HIF-2α inhibitor belzutifan to adjuvant pembrolizumab improves outcomes in patients with resected clear-cell renal-cell carcinoma at high risk of recurrence. 1,841 participants were randomized 1:1 to receive pembrolizumab 400 mg IV every six weeks for ≤9 doses combined with either belzutifan 120 mg orally once daily or placebo for up to one year; the primary endpoint was investigator-assessed disease-free survival (DFS), with overall survival (OS) and safety as secondary endpoints. After a median follow-up of 28.4 months, the combination significantly prolonged DFS versus pembrolizumab alone (HR 0.72, 95% CI 0.59–0.87; 24-month DFS 80.7% vs 73.7%; P<0.001), while interim OS showed no significant difference (HR 0.78, 95% CI 0.51–1.19; 24-month OS 96.2% vs 95.7%; P=0.24). Grade ≥3 adverse events occurred in 52.1% of combination-therapy patients versus 30.2% with monotherapy, leading to the conclusion that pembrolizumab-belzutifan improves DFS but increases high-grade toxicity post-nephrectomy.
10.1056/NEJMoa2518245
Casdatifan shows durable response linked to HIF-2α biology in kidney cancer.
NATURE · Q1 JOURNAL - RANK #2/135TOP-TIER
This prospective clinical trial investigated casdatifan, a selective HIF-2α inhibitor, as monotherapy in individuals with refractory metastatic clear cell renal cell carcinoma (ccRCC) using dose-expansion data from the ARC-20 study (NCT05536141), including cohorts of 100 mg QD (n = 32) and total (n = 127). The study found confirmed objective response rates of 35% (95% CI: 19-55%) for the 100 mg QD cohort and 31% (95% CI: 23-40%) for the total cohort, with median progression-free survival of 12.2 months (95% CI: 9.4-20.6) in the total cohort, and manageable safety profile. Greater reductions in serum erythropoietin correlated with improved outcomes, and higher HIF-2α expression linked to prolonged PFS. The study concludes that casdatifan yields meaningful, durable responses in metastatic ccRCC, driven by HIF-2α biology.
10.1038/s41586-026-10718-x
Long-term follow-up from the OMNIVORE trial: response-adaptive nivolumab and ipilimumab in advanced renal cell carcinoma.
J IMMUNOTHER CANCER · Q1 JOURNAL - RANK #12/183TOP-TIER
The OMNIVORE trial, a phase II response-adaptive study, evaluated a strategy of nivolumab monotherapy followed by treatment discontinuation in early responders (Arm A) or salvage ipilimumab addition in non-responders (Arm B) for advanced renal cell carcinoma. With a median follow-up of 59.4 months in Arm A and 31.4 months in Arm B, the 3-year overall survival rate was 64% overall, 83% in Arm A, and 63% in Arm B. Among Arm A patients, 50% remained off nivolumab at 1 year, with 5 maintaining responses beyond 43 months, while Arm B patients had a median progression-free survival of 4.6 months. The study concluded that early nivolumab responders achieved prolonged treatment-free survival, but salvage ipilimumab offered limited benefit, supporting upfront dual checkpoint blockade as the preferred approach.
10.1136/jitc-2026-015501
Jun 08 – Jun 15, 2026
3D surgical navigation contributes to renal function preservation during robot-assisted partial nephrectomy.
J ROBOT SURG · Q1 JOURNAL - RANK #48/312
This single-center cohort study prospectively enrolled 30 consecutive patients undergoing navigation-assisted robot-assisted partial nephrectomy (RAPN) and matched them with historical controls (2017-2022) by clinical tumor size and RENAL nephrometry score. The primary endpoint was excess resected parenchyma (resected specimen volume minus tumor volume); secondary endpoints were 3-month declines in serum eGFR and DTPA-measured ipsilateral GFR. Navigation-assisted RAPN significantly reduced excess resected parenchyma (2.7 vs. 6.2 cm³, p=0.013), but declines in serum eGFR (6.0% vs. 10.8%) and ipsilateral GFR (21.4% vs. 26.0%) were not statistically significant. The authors conclude navigation significantly reduces excess parenchymal resection, suggesting potential long-term renal function benefit, especially in high-complexity tumors.
10.1007/s11701-026-03512-4
Jun 01 – Jun 08, 2026
Participant-Reported Preference for Pembrolizumab Administered Subcutaneously or Intravenously: A Randomized, Open-Label, Phase II Study.
JCO ONCOL PRACT · Q1 JOURNAL - RANK #81/326
This phase II, open-label, crossover study (NCT06099782) evaluated participant preference for subcutaneous (SC) versus intravenous (IV) pembrolizumab in 147 patients with resected melanoma, renal cell carcinoma, or metastatic non-small cell lung cancer. Participants were randomized 1:1 to SC (395 mg) or IV (200 mg) pembrolizumab for three cycles before crossover, with preference assessed via Patient Preference Questionnaire. Results showed 65% (95% CI: 56-74) preferred SC, citing less clinic time (64%), and 68% chose SC for continued treatment; grade 3-4 AEs occurred in 1% (SC) and 7% (IV) during initial cycles. The study concluded SC pembrolizumab offers greater convenience and comparable safety to IV administration in cancer treatment.
10.1200/OP-25-01248
Papillary renal cell carcinoma - exploratory results of the SUNNIFORECAST trial comparing Ipilimumab plus Nivolumab vs standard of care as first line therapy based on central pathological review.
EUR J CANCER · Q1 JOURNAL - RANK #45/326
This was a prospective, investigator-initiated, phase II trial comparing ipilimumab plus nivolumab versus standard of care in advanced papillary renal cell carcinoma, based on central pathological review. A total of 127 patients with confirmed pRCC were included (64 receiving ipilimumab/nivolumab and 63 on standard therapy). Reported outcomes showed a 12-month OS rate of 74.77% with ipilimumab/nivolumab and 63.44% with SOC (p=0.085), and median OS of 24.89 vs 18.88 months, respectively. Although exploratory and limited, results suggest a potential OS benefit among patients with higher PD-L1 CPS (>1).
10.1016/j.ejca.2026.116816
May 25 – Jun 01, 2026
Pretreatment intratumoral mature TLSs in non-clear cell renal cell carcinoma are associated with response to immunotherapy rechallenge.
J IMMUNOTHER CANCER · Q1 JOURNAL - RANK #12/183TOP-TIER
This prospective human clinical trial evaluated the efficacy, safety, and predictive markers of immune checkpoint inhibitor (ICI) rechallenge in 39 patients with metastatic non-clear cell renal cell carcinoma (nccRCC). The study reported a median progression-free survival (PFS) of 11.8 months, an objective response rate (ORR) of 13.9%, and a disease control rate (DCR) of 69.4%. Patients with a high mature intratumoral tertiary lymphoid structure (m-iTLS) score had significantly better outcomes (ORR: 50.0% vs 0.0%, PFS: 28.2 vs 5.0 months), and ICI rechallenge was well tolerated with no treatment-related deaths observed. The findings highlight potential biomarkers for predicting ICI rechallenge efficacy and emphasize the therapy’s clinical benefit in this patient population, although additional validation is required.
10.1136/jitc-2025-013526
Safety, pharmacokinetics, pharmacodynamics, and antitumor activity of cergutuzumab amunaleukin: a phase I study in patients with advanced and/or metastatic solid tumors.
ESMO OPEN · Q1 JOURNAL - RANK #36/326
This phase I study evaluated the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of cergutuzumab amunaleukin (CA) in 60 patients with advanced/metastatic CEA-positive solid tumors. The study comprised two parts: single-dose (0.1-6 mg, n=5) and multiple ascending doses (10-40 mg q2w, n=31; 6-30 mg qw, n=24), establishing an MTD of 30 mg q2w with dose-limiting toxicities including Gr4 hypophosphatemia and thrombocytopenia. Pharmacokinetics showed dose-proportional exposure (6-40 mg), and pharmacodynamics revealed preferential expansion of CD8+ T and NK cells. No objective responses were observed, but 11% (6/53) achieved stable disease (median duration 4.5 months), supporting further combination therapy development.
10.1016/j.esmoop.2026.107697
Pembrolizumab plus high-dose IL-2 in advanced clear cell renal cell carcinoma: six-year survival outcomes and molecular signatures from a phase 2 trial.
NAT COMMUN · Q1 JOURNAL - RANK #10/135TOP-TIER
This single-arm phase 2 trial evaluated a fixed-duration regimen of pembrolizumab plus high-dose IL-2 in 26 treatment-naive patients with advanced clear cell renal cell carcinoma. The primary objectives of safety and response were previously met, with the overall response rate exceeding the 45% threshold. At a median follow-up of 76.4 months, the objective response rate was 73%, including 42% complete responses, median overall survival exceeded 84 months, and median progression-free survival was 19.3 months. The authors conclude that this immunotherapy combination yields durable responses and a prolonged treatment-free interval without high-grade toxicities.
10.1038/s41467-026-73336-1