Clinical Trials for Kidney Cancer

Phase III Trial of Immunotherapy-Based Combination Therapy With or Without Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma (PROBE 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.

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.

HealthScout AI summary: Adults with newly diagnosed metastatic RCC (clear or non–clear cell, primary tumor in place) who achieve disease control after ~12 weeks of first-line ICI-based therapy (nivolumab/ipilimumab; or pembrolizumab+axitinib; or avelumab+axitinib) are randomized to continue systemic therapy alone versus cytoreductive nephrectomy followed by the same regimen. ICIs target PD-1/PD-L1 and CTLA-4 to restore antitumor immunity; axitinib is a VEGFR TKI.

ClinicalTrials.gov ID: NCT04510597

GU-187: Phase II Trial of Alternative Cabozantinib Dosing Schedule in Metastatic Renal Cell Carcinoma and Neuroendocrine Tumors

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.

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.

HealthScout AI summary: Adults with metastatic RCC (clear or non–clear cell) or progressive well-differentiated NETs receive cabozantinib using a finer titration schema (starting 40 mg daily with 10 mg adjustments; max 60 mg), with frontline RCC patients in one cohort also receiving standard-dose nivolumab (PD‑1 inhibitor). Excludes prior cabozantinib and significant cardiovascular/GI risks; NET cohort may continue stable somatostatin analogs.

ClinicalTrials.gov ID: NCT05263050

A Phase II Randomized Trial of Radium-223 Dichloride and Cabozantinib in Patients With Advanced Renal Cell Carcinoma With Bone Metastasis (RadiCal)

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.

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.

HealthScout AI summary: Adults with metastatic renal cell carcinoma of any subtype and at least one untreated bone metastasis, receiving mandatory osteoclast-targeted therapy, randomized to cabozantinib alone versus cabozantinib plus radium‑223 dichloride. Cabozantinib is a multikinase inhibitor (MET/VEGFR/AXL), and radium‑223 is a bone-targeted alpha‑emitting radiopharmaceutical; prior cabozantinib, radiopharmaceuticals, or hemibody RT are excluded.

ClinicalTrials.gov ID: NCT04071223

Cyto-KIK; TRIAL (CYTO Reductive Surgery in Kidney Cancer Plus Immunotherapy (Nivolumab) and Targeted Kinase Inhibition (Cabozantinib)

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.

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.

HealthScout AI summary: Single-arm study for adults with previously untreated metastatic clear cell RCC (ECOG 0–1) eligible for cytoreductive nephrectomy, giving neoadjuvant nivolumab (PD‑1 inhibitor) plus cabozantinib (VEGFR/MET/AXL TKI) for ~12 weeks, then nephrectomy with cabozantinib held 14–21 days pre-op and therapy resumed if benefiting. Aims to increase complete responses and assess tumor shrinkage, survival, and surgical outcomes.

ClinicalTrials.gov ID: NCT04322955

A Phase 2 Study of Nivolumab and Ipilimumab in Combination With Sirolimus and Prednisone in Kidney Transplant Recipients With Selected Unresectable or Metastatic Cutaneous Cancers

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.

HealthScout AI summary: Adults with functioning kidney transplants and unresectable or metastatic cutaneous melanoma (non-uveal), cSCC, BCC, or Merkel cell carcinoma receive nivolumab (PD‑1 inhibitor) plus ipilimumab (CTLA‑4 inhibitor) with concurrent sirolimus (mTOR inhibitor) and prednisone, followed by nivolumab maintenance. Designed to balance antitumor activity with graft preservation; prior PD-(L)1 exposure allowed, with re-induction permitted at progression.

ClinicalTrials.gov ID: NCT05896839

A Pilot Safety and Feasibility Study of Lymphodepleting Total Body Irradiation (TBI) Plus Cyclophosphamide Prior to Ciltacabtagene Autoleucel (Carvykti; Cilta-cel) for Multiple Myeloma (MM) Patients With Impaired Renal Function

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.

HealthScout AI summary: Adults with multiple myeloma and significant renal impairment (eGFR <45) receive cyclophosphamide plus low-dose total body irradiation for lymphodepletion instead of fludarabine, followed by ciltacabtagene autoleucel (BCMA-directed CAR T with dual BCMA-binding domains). The study assesses safety/feasibility of this TBI-based approach and its impact on CAR T expansion and antimyeloma activity.

ClinicalTrials.gov ID: NCT06623630

Pilot Study of Daratumumab in Combination With Bortezomib, Cyclophosphamide, and Dexamethasone (Dara-CyBorD) in Newly Diagnosed Multiple Myeloma Patients With Renal Failure

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.

HealthScout AI summary: Newly diagnosed multiple myeloma patients with significant renal impairment (CrCl <60 mL/min and/or dialysis) receive four 28-day cycles of subcutaneous daratumumab-hyaluronidase (anti‑CD38) plus bortezomib, cyclophosphamide, and dexamethasone, with outcomes focused on depth of hematologic response and renal recovery. Planned enrichment for approximately 50% African American participants; post-induction therapy follows standard practice (ASCT if eligible or additional Dara-CyBorD, then maintenance with lenalidomide plus SC daratumumab).

ClinicalTrials.gov ID: NCT06142396

A Phase 2 Study of Bevacizumab, Erlotinib and Atezolizumab in Subjects With Advanced Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC) Associated or Sporadic Papillary Renal Cell Cancer

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.

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.

HealthScout AI summary: Single-arm study for adolescents and adults with advanced measurable HLRCC-associated RCC or sporadic/non-HLRCC papillary RCC (prior VEGF therapy allowed, but no prior bevacizumab or PD-1/PD-L1 in the advanced setting), including patients with treated/stable brain mets. Treatment combines bevacizumab (anti-VEGF), erlotinib (EGFR TKI), and atezolizumab (anti–PD-L1) given in 21-day cycles until progression/toxicity, aiming to improve response and disease control.

ClinicalTrials.gov ID: NCT04981509

A Phase II Study of CyBorD (Cyclophosphamide, Bortezomib, Dexamethasone) Plus Daratumumab for Patients With Monoclonal Gammopathy of Renal Significance (MGRS)

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.

HealthScout AI summary: Adults with MGRS due to plasma cell dyscrasia, including NDMM with cast nephropathy or other biopsy-proven MGRS lesions (excluding AL amyloidosis), impaired renal function/proteinuria, and no prior anti–plasma cell therapy receive CyBorD plus subcutaneous daratumumab. Daratumumab is an anti‑CD38 monoclonal antibody; treatment includes 8 induction cycles with optional ASCT and, if ineligible, maintenance bortezomib/dexamethasone every other week plus daratumumab every 4 weeks.

ClinicalTrials.gov ID: NCT06083922

Phase I/II Study of Seleno-L Methionine (SLM) in Sequential Combination With Fixed Doses and Schedules of Axitinib and Pembrolizumab (SAP) in Locally Advanced and Metastatic Clear Cell Renal Cell Carcinoma (ccRCC)

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.

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.

HealthScout AI summary: Adults with untreated, locally advanced or metastatic clear cell RCC (ECOG 0–1) receive standard pembrolizumab (anti–PD-1) plus axitinib (VEGFR TKI) with the addition of oral seleno-L-methionine (an organic selenium agent proposed to modulate redox stress and sensitize tumors), after a 2-week SLM run-in. Excludes untreated CNS mets and significant cardiovascular risks; primary aims are safety/MTD of SLM and preliminary response rates.

ClinicalTrials.gov ID: NCT05363631