Clinical Trials for Kidney Cancer

An Open-label Dosimetry, Biodistribution, Tolerability and Safety Study of Lutetium (177Lu) Vipivotide Tetraxetan in Participants With Progressive PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC) With Moderately and Severely Impaired and With Normal 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.

TrialFetch AI summary: Adults with progressive PSMA-positive mCRPC (ECOG 0–2) stratified by renal function (normal, moderate, severe impairment) receive lutetium-177 vipivotide tetraxetan (177Lu-PSMA-617), a PSMA-targeted beta-emitting radioligand therapy, to assess biodistribution, dosimetry, PK, urinary excretion, and safety; dosing is 7.4 GBq q6 weeks (6 cycles for normal/moderate; 3 with possible extension in severe impairment). Excludes prior PSMA RLT and significant QT risk/medications during Cycle 1; all require PSMA-avid disease on 68Ga-PSMA-11 PET/CT.

ClinicalTrials.gov ID: NCT06004661

Randomized Phase II Rescuing Cancer Immunotherapy With Plasma Exchange in Bladder Cancer 1 (ReCIPE-B1)

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 metastatic urothelial carcinoma that progressed after prior enfortumab vedotin plus pembrolizumab are randomized to re-challenge with enfortumab vedotin (nectin-4–targeting ADC delivering MMAE) plus pembrolizumab (PD-1 inhibitor) with added therapeutic plasma exchange (days 1–3 of cycles 1–3) versus physician’s choice next-line standard of care. Eligible patients have measurable disease and ECOG 0–2; key exclusions include variant histologies (neuroendocrine, micropapillary, signet ring) and significant comorbidity.

ClinicalTrials.gov ID: NCT07087860

Phase II Study of Olaparib in Metastatic Renal Cell Carcinoma Patients Harboring a BAP-1 or Other DNA Repair Gene Mutations (ORCHID)

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.

TrialFetch AI summary: Single-arm study of olaparib, an oral PARP1/2 inhibitor, in adults with metastatic RCC (clear or non–clear cell) harboring pathogenic BAP1 or other DDR/HRR gene alterations (e.g., ATM, BRCA1/2, PALB2), after prior ICI and/or anti-VEGF therapy. Eligible patients require ECOG 0–1 and measurable disease; prior PARP inhibitor use and uncontrolled CNS disease are excluded.

ClinicalTrials.gov ID: NCT03786796

A Phase 0 Pilot Study of Memory-like Natural Killer (NK) Cell Immune Therapy in Patients With Renal Cell Carcinoma or Urothelial Carcinoma

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 advanced/metastatic clear cell, translocation, or chromophobe RCC or urothelial carcinoma with measurable disease and prior progression on PD-1/PD-L1 (plus prior VEGFR TKI for RCC and chemo or ADC for UC) receive autologous cytokine-induced memory-like NK cells after lymphodepletion, supported by low-dose IL-2. CIML NK cells are ex vivo cytokine-activated NK cells designed to enhance innate antitumor cytotoxicity, cytokine production, and persistence; treated, stable brain metastases allowed.

ClinicalTrials.gov ID: NCT06318871

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.

TrialFetch 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.

TrialFetch 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.

TrialFetch 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.

TrialFetch 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.

TrialFetch 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.

TrialFetch 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