Clinical Trials for Kidney Cancer

CAST-AI: Cystectomy After Systemic Therapy With ADC and Immunotherapy

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults with newly diagnosed, node-positive or metastatic urothelial carcinoma (bladder or upper tract), ECOG 0–2, receive first-line enfortumab vedotin (nectin‑4–targeting MMAE ADC) plus pembrolizumab (PD‑1 inhibitor) for at least 4 cycles, then proceed to cytoreductive cystectomy and/or ureterectomy if surgical candidates, with optional metastasis-directed therapy and potential postoperative maintenance EV/pembrolizumab. Excludes prior systemic therapy or checkpoint inhibitor exposure, significant comorbidities/autoimmunity, and prior pelvic RT.

ClinicalTrials.gov ID: NCT06764095

Phase II Single-Arm Study of Enfortumab Vedotin (EV) Plus Pembrolizumab in the Treatment of Locally Advanced or Metastatic Bladder Cancer of Variant Histology

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults with unresectable locally advanced or metastatic bladder cancers of variant or non-urothelial epithelial histologies (e.g., micropapillary, plasmacytoid, sarcomatoid, squamous, adenocarcinoma/urachal), ECOG 0–1, treatment-naïve or previously treated, excluding prior EV or PD-1/L1 therapy. Treatment is enfortumab vedotin (Nectin-4–targeting antibody–drug conjugate delivering MMAE) plus pembrolizumab (PD-1 inhibitor).

ClinicalTrials.gov ID: NCT05756569

A Randomized Trial of Maintenance Systemic Therapy After Radiation for Oligometastatic Renal Cell Carcinoma (ASTROs)

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults with oligometastatic clear cell RCC (≤5 measurable lesions; ECOG 0–1) receive definitive radiation to all treatable sites and are randomized to 1 year of maintenance pembrolizumab vs observation. Pembrolizumab is an anti–PD-1 antibody immunotherapy; brain metastases allowed, prior recent immunotherapy and significant immunosuppression excluded.

ClinicalTrials.gov ID: NCT06004336

A Phase 1b/2 Study of Abemaciclib Plus Cabozantinib in Immune Checkpoint Blockade-pretreated Metastatic Clear Cell Renal Cell Carcinoma

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults with metastatic clear cell RCC who have progressed after 2–3 prior lines including a PD-1/PD-L1 inhibitor and a VEGFR TKI receive oral abemaciclib (CDK4/6 inhibitor) plus cabozantinib (multikinase inhibitor targeting MET/VEGFR2/AXL). Single-arm study assesses safety/MTD and preliminary efficacy; excludes prior abemaciclib/cabozantinib and patients with uncontrolled CNS disease, significant CV risk, or strong CYP3A modulator use.

ClinicalTrials.gov ID: NCT06835972

Phase I/II Trial of Inulin Gel in Combination With Ipilimumab and Nivolumab in Advanced Renal Cell Carcinoma [ICON Trial]

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults with untreated metastatic or progressive locally advanced clear cell/sarcomatoid RCC (ECOG ≤2) are randomized to standard ipilimumab plus nivolumab versus the same regimen plus oral inulin gel, a fermentable prebiotic fiber intended to modulate the gut microbiome to enhance checkpoint inhibitor response. Key exclusions include active/unstable brain mets, significant GI disease/surgery, recent antibiotics/probiotics, and autoimmune conditions requiring immunosuppression.

ClinicalTrials.gov ID: NCT06866262

A Pilot, Rapid Sequencing of First Line Cabozantinib, Ipilimumab and Nivolumab, and Lenvatinib and Everolimus in Patients with Metastatic or Unresectable Clear Cell Renal Cell Carcinoma

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults with untreated metastatic or unresectable clear cell RCC (ECOG 0–1; stable treated brain mets allowed) receive a rapid sequence: cabozantinib lead-in (multi-target TKI inhibiting MET/VEGFR/AXL/RET) → ipilimumab (CTLA-4) plus nivolumab (PD-1) → response-adapted maintenance with nivolumab or switch at progression to cabozantinib or lenvatinib (VEGFR/FGFR TKI) plus everolimus (mTOR inhibitor). Excludes prior systemic therapy for advanced disease and significant autoimmune, cardiovascular, bleeding, or GI risks.

ClinicalTrials.gov ID: NCT05188118

A Phase 1 Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb819 in Subjects With Relapsed or Refractory Clear Cell Renal Cell Carcinoma

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with relapsed/refractory clear cell RCC after standard therapy (ECOG 0–1) receive XmAb819, a bispecific T‑cell engager targeting ENPP3 on tumor cells and CD3 on T cells, administered with IV or SC priming/step‑up dosing. Excludes prior anti‑ENPP3/CD203c therapy, active CNS disease (unless treated/stable), and active autoimmune disease requiring systemic therapy.

ClinicalTrials.gov ID: NCT05433142

A Phase 1, Open-label, Dose Escalation and Dose Expansion Study, to Investigate the Safety, Tolerability, and Pharmacokinetic Profile of AB521 Monotherapy and Combination Therapies in Participants With Clear Cell Renal Cell Carcinoma and Other Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with ECOG 0–1: dose escalation enrolls any advanced solid tumor lacking standard options; expansion enrolls histologically confirmed ccRCC. Treatments include the oral HIF-2α inhibitor casdatifan (AB521) as monotherapy or combined with cabozantinib or the anti–PD-1 antibody zimberelimab.

ClinicalTrials.gov ID: NCT05536141

A Phase I/II Study to Evaluate the Safety and Efficacy of Bicalutamide in Combination with Sunitinib in Patients with Receptor Tyrosine Kinase Inhibitor Resistant Renal Cell Carcinoma

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults with advanced RCC that has progressed on prior RTKI therapy (ECOG 0–2) receive bicalutamide 50 mg daily (androgen receptor antagonist) plus sunitinib 25–50 mg on a 2-weeks-on/1-week-off schedule. Single-arm study assessing safety and objective response, with exploratory androgen-signaling biomarkers (AR IHC, AR-related miRNAs, KLK2).

ClinicalTrials.gov ID: NCT06222593

Lymphodepleting Chemotherapy With Fludarabine and Cyclophosphamide Prior to Infusion of CAR T Cell Therapy in Patients With Moderate-Severe Renal Dysfunction

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults with multiple myeloma, leukemia, or lymphoma and moderate to severe renal impairment (including dialysis) who are candidates for commercial CAR T therapy receive renal function–adjusted fludarabine/cyclophosphamide lymphodepletion prior to CAR T infusion. The study assesses safety/feasibility (CRS, ICANS, cytopenias) of dose-reduced fludarabine (20–50%) and cyclophosphamide (0–25% reduction) based on renal function.

ClinicalTrials.gov ID: NCT05909059