Clinical Trials for Kidney Cancer

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.

HealthScout 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.

HealthScout 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

Randomized Phase II Stereotactic Ablative Radiation Therapy (SABR) for Metastatic Unresected Renal Cell Carcinoma (RCC) Receiving Immunotherapy (SAMURAI)

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.

HealthScout AI summary: Adults with unresected, metastatic or node-positive RCC (IMDC intermediate/poor risk) receiving standard first-line immunotherapy (IO-IO or IO-VEGF regimens) are randomized to immunotherapy alone versus the same therapy plus stereotactic ablative radiotherapy (SABR) to the intact primary kidney tumor. Regimens may include nivolumab + ipilimumab (PD-1 + CTLA-4), pembrolizumab or nivolumab combinations with VEGF/VEGFR TKIs (axitinib, lenvatinib, cabozantinib), or avelumab + axitinib.

ClinicalTrials.gov ID: NCT05327686

A Randomized Phase 2 Trial of Nivolumab, Relatlimab Plus Ipilimumab vs. Nivolumab Plus Ipilimumab in First-line Advanced Renal Cell Carcinoma (RCC)

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.

HealthScout AI summary: Untreated adults with stage IV clear cell–containing RCC (KPS ≥70%) are randomized to standard nivolumab plus ipilimumab versus a triplet adding relatlimab, a LAG‑3–blocking monoclonal antibody, to nivolumab and ipilimumab. Excludes prior systemic RCC therapy, CNS mets, and active autoimmune disease; endpoints include safety and antitumor activity (RECIST 1.1).

ClinicalTrials.gov ID: NCT06708949

Phase 2 Study of Combination Tivozanib and Nivolumab in Advanced Non-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.

HealthScout AI summary: Adults with metastatic non–clear cell RCC (papillary, chromophobe, oncocytic, unclassified/NOS; ≤1 prior systemic therapy) receive tivozanib (oral VEGFR-1/2/3 TKI) plus nivolumab (IV PD-1 inhibitor), including patients with controlled/asymptomatic brain metastases. Excludes prior tivozanib/nivolumab, medullary/collecting duct histologies, significant autoimmune disease, and uncontrolled hypertension.

ClinicalTrials.gov ID: NCT06053658

Phase 2, Open-label, Single Cohort, Multicenter Trial for Sequential Treatment of High Dose Cabozantinib on/After Progression on Cabozantinib Monotherapy in Advanced Renal Cell Carcinoma (Seq-Cabo)

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.

HealthScout AI summary: Adults with unresectable or metastatic RCC of any histology who previously benefited from and then progressed on cabozantinib 60 mg daily receive cabozantinib dose escalation to 80 mg daily. Cabozantinib is a multikinase inhibitor targeting VEGFR, MET, and AXL; prior PD-1/PD-L1 therapy is allowed, and participants must have measurable disease and ECOG 0–2.

ClinicalTrials.gov ID: NCT05931393

Pilot Study of an Implantable Microdevice for in Situ Evaluation of Drug Response in 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.

HealthScout AI summary: Adults with suspected or confirmed metastatic RCC undergoing standard-of-care nephrectomy or metastasectomy receive a percutaneously placed implantable microdevice 72±24 hours pre-op that releases microdoses of up to 19 anticancer agents locally into the tumor to assess in situ drug response; the device and surrounding tissue are removed at surgery. Investigational component is the microdevice-based response profiling (not therapeutic), using FDA-approved or RCC-relevant agents (e.g., TKIs, IO, targeted therapies) to inform sensitivity.

ClinicalTrials.gov ID: NCT05700461

A Phase II Study Assessing the Feasibility and Clinical Efficacy of Adaptive Immunotherapy Combination With VEGFR-TKI in Patients With Advanced 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.

HealthScout AI summary: Treatment-naïve adults with unresectable/metastatic clear cell RCC (ECOG 0–2) receive pembrolizumab (PD‑1 inhibitor) plus axitinib (VEGFR‑1/2/3 TKI) with an adaptive on–off dosing strategy triggered by RECIST responses on serial imaging. Excludes active CNS disease unless treated/stable and significant recent cardiovascular events; controlled HBV/HCV/HIV allowed.

ClinicalTrials.gov ID: NCT06860386

Phase II Trial Of Stereotactic Body Radiation Therapy (SBRT) for Oligoprogression on Immune Checkpoint Inhibitors (ICI) in Metastatic 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.

HealthScout AI summary: Adults with metastatic renal cell carcinoma on a stable immune checkpoint inhibitor regimen who develop 1–5 oligoprogressive lesions receive SBRT to all progressing sites (with optional local therapies to some lesions) while continuing the same ICI. Excludes brain-only progression; aims to prolong disease control without switching systemic therapy.

ClinicalTrials.gov ID: NCT04974671

Phase III Randomized Trial of Stereotactic Ablative Radiotherapy (SAbR) for Oligometastatic Advanced Renal Carcinoma (SOAR)

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.

HealthScout AI summary: Adults with oligometastatic renal cell carcinoma (2–5 measurable lesions; primary controlled; IMDC favorable/intermediate; ECOG 0–2) are randomized to stereotactic ablative radiotherapy to all metastases followed by standard systemic therapy versus standard systemic therapy alone. Systemic options per guideline may include immune checkpoint inhibitors and/or VEGF/tyrosine kinase inhibitors; key exclusions include brain metastases, sarcomatoid component, and prior systemic therapy for metastatic disease.

ClinicalTrials.gov ID: NCT05863351