Clinical Trials for Kidney Cancer

A Phase 1/2 Study of REGN5678 (Anti-PSMAxCD28) With or Without Cemiplimab (Anti-PD-1) in Patients With Metastatic Castration-Resistant Prostate Cancer and Other Tumors Associated With PSMA Expression

Active drug

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

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.

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 PSMA-expressing tumors, primarily mCRPC post–ARPI (and including a post–177Lu‑PSMA‑617 cohort) and previously treated metastatic ccRCC, receive REGN5678 (nezastomig), a PSMA×CD28 costimulatory bispecific antibody, as monotherapy or with the PD‑1 inhibitor cemiplimab. Aims include identifying active/safe doses and assessing responses, with combination use tempered by prior immune‑related toxicities.

ClinicalTrials.gov ID: NCT03972657

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.

HealthScout 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.

HealthScout 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.

HealthScout 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 II Randomized Trial of Cabozantinib (NSC #761968) With or Without Atezolizumab (NSC #783608) in Patients With Advanced Papillary Renal Cell Carcinoma (PAPMET2)

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 papillary RCC (type 1/2; papillary component allowed), measurable extracranial disease, and PS 0–2 are randomized to cabozantinib alone vs cabozantinib plus atezolizumab. Cabozantinib is a multikinase inhibitor targeting MET/VEGFR2/AXL, and atezolizumab is an anti–PD-L1 antibody; key exclusions include prior cabozantinib, recent PD-1/PD-L1 therapy, uncontrolled CNS disease, and significant cardiovascular or bleeding risk.

ClinicalTrials.gov ID: NCT05411081

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.

HealthScout 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.

HealthScout 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.

HealthScout 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 Multicenter Study Evaluating the Safety and Efficacy of ALLO-316 Following ALLO-647 Containing Conditioning Regimen in Subjects With Advanced or Metastatic Clear Cell Renal Cell Carcinoma

Active drug

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

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.

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 advanced/metastatic clear cell RCC after prior IO and VEGF inhibitor therapy receive lymphodepletion with fludarabine/cyclophosphamide plus ALLO‑647 followed by ALLO‑316, an off‑the‑shelf allogeneic CAR T therapy targeting CD70. Designed to assess safety, dose, and preliminary activity; excludes prior anti‑CD70 therapy and those with active/unstable CNS metastases.

ClinicalTrials.gov ID: NCT04696731

Combination Nivolumab and Ipilimumab With and Without Camu Camu in First Line Treatment of 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 untreated metastatic clear-cell or sarcomatoid RCC (IMDC intermediate/poor risk, ECOG 0–1) receive standard nivolumab (PD‑1 inhibitor) plus ipilimumab (CTLA‑4 inhibitor), randomized to add daily camu camu, a polyphenol-rich prebiotic intended to modulate the gut microbiome (increase Ruminococcus) to potentially enhance immunotherapy response. Excludes prior checkpoint inhibitors, active autoimmune disease needing >10 mg steroids, unstable CNS mets, and recent probiotic/prebiotic use.

ClinicalTrials.gov ID: NCT06049576