Clinical Trials for Kidney Cancer

Phase 2 Study of Cabozantinib as a Maintenance Agent to Prevent Progression or Recurrence in High-Risk Pediatric Solid 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: Maintenance cabozantinib (oral multi-kinase inhibitor of MET/VEGFR2/AXL/RET) for 12 months in children, adolescents, and young adults (≥18 months to <40 years) with ultra–high-risk solid tumors who have achieved at least stable disease after their most recent therapy and can start within 12 weeks. Includes strata such as neuroblastoma, metastatic Ewing sarcoma, osteosarcoma, high-risk rhabdomyosarcoma, DSRCT, and other high-risk sarcomas; single-arm, compared to historical controls.

ClinicalTrials.gov ID: NCT05135975

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 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.

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 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 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

Optimal Treatment by Invoking Biologic Clusters in Renal Cell Carcinoma (OPTIC 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.

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: Treatment-naive adults with advanced/metastatic clear cell RCC are assigned by tumor RNAseq biologic clusters (1/2 vs 4/5) to either ipilimumab plus nivolumab (CTLA-4 + PD-1 blockade) or nivolumab plus cabozantinib (PD-1 inhibitor with VEGF/MET/AXL-targeting TKI). Includes patients with controlled brain mets; key exclusions address cardiovascular risk, bleeding/proteinuria, and factors affecting cabozantinib safety or absorption.

ClinicalTrials.gov ID: NCT05361720

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