Clinical Trials for Kidney Cancer

PRISM: Phase 1b of Retifanlimab and Ruxolitinib In Solid Malignancies Progressing on Prior Checkpoint Inhibition

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.

TrialFetch AI summary: Adults with advanced/metastatic clear cell renal cell carcinoma or non-small cell lung cancer who had at least stable disease on one prior line of PD-1/PD-L1 therapy but then radiographically progressed within 6 months of stopping it (ECOG 0–1; measurable disease; no active CNS disease or uncontrolled autoimmune disease) and lack/decline standard options. Patients receive retifanlimab (anti–PD-1 antibody) 500 mg IV every 4 weeks as checkpoint rechallenge combined with oral ruxolitinib (JAK1/2 inhibitor) twice daily with dose escalation to define the recommended dose.

ClinicalTrials.gov ID: NCT07219576

A Randomized Study of Nivolumab and Ipilimumab With and Without EXL01 in First-Line Treatment of Metastatic Renal Cell Carcinoma (mRCC)

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.

TrialFetch AI summary: Adults with treatment-naïve metastatic/advanced stage IV renal cell carcinoma with a clear-cell component (ECOG 0–2; measurable disease; select stable treated brain metastases allowed) receive standard nivolumab (PD-1 inhibitor) plus ipilimumab (CTLA-4 inhibitor) induction for 4 cycles followed by nivolumab maintenance, randomized to with or without oral EXL01. EXL01 is an investigational live biotherapeutic containing Faecalibacterium prausnitzii intended to modulate the gut microbiome and potentially enhance systemic immune tone/checkpoint inhibitor responsiveness.

ClinicalTrials.gov ID: NCT07128680

Knight Cancer Institute Study of Histology-Agnostic Immunotherapy With Focus on Timing: - Knight SHIFT - A Prospective, Multi-Histology Pragmatic Study

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.

TrialFetch AI summary: Adults with measurable advanced/metastatic solid tumors eligible for standard FDA-approved immune checkpoint inhibitor therapy (anti–PD-1/PD-L1 and/or anti–CTLA-4), including NSCLC, HNSCC, RCC, biliary, HCC, and melanoma, who are ICI-naive. Patients are randomized to receive their planned standard-of-care immunotherapy in the morning versus afternoon for the first 4 doses to evaluate whether administration timing affects outcomes.

ClinicalTrials.gov ID: NCT07405086

Phase III Double Blinded Trial of Immune-Based Therapy With a Live Biotherapeutic MO-03 or Placebo for Frontline Therapy of Advanced Clear Cell Renal Cell Carcinoma [BioFront 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.

TrialFetch AI summary: Adults with previously untreated advanced or metastatic RCC with a clear cell component receive investigator-selected first-line ipilimumab/nivolumab or an immunotherapy/TKI combination plus oral MO-03 or placebo. MO-03 is a live, butyrate-producing Clostridium butyricum CBM 588 biotherapeutic intended to modulate the gut microbiome and enhance checkpoint inhibitor activity.

ClinicalTrials.gov ID: NCT07383441

Belzutifan's Role in Active Surveillance Versus Treatment for Indolentmetastatic Clear Cell Renal Ccell Carcinoma (BRAVE-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.

TrialFetch AI summary: Adults with previously untreated, indolent metastatic clear cell RCC (IMDC favorable/intermediate risk, ECOG 0–1) who are appropriate for observation are randomized to daily oral belzutifan, a HIF-2α inhibitor, or active surveillance without anticancer therapy.

ClinicalTrials.gov ID: NCT07023432

An Open-label Phase 1/2 Dose Finding, Safety and Efficacy Study of Oral NEO212 in Patients with Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Uncontrolled Brain Metastasis in Patients with Select 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.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

TrialFetch AI summary: This clinical trial evaluates the safety and efficacy of the investigational drug NEO212, a novel conjugate of temozolomide and perillyl alcohol with enhanced brain penetration, in adults with Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype, or uncontrolled brain metastases from select solid tumors, including combinations with standard treatments like pembrolizumab or ipilimumab.

ClinicalTrials.gov ID: NCT06047379

Single Arm Study to Assess the Immune Effects of Fermented Wheat Germ (FWG) Nutritional Supplementation in Patients With Advanced Malignancies Being Treated With Standard of Care Checkpoint Inhibitor-Based Therapy

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 advanced non-small cell lung, renal cell, melanoma, colorectal, or triple-negative breast cancers eligible for standard checkpoint inhibitor immunotherapy will receive oral fermented wheat germ supplementation (a nutritional product with proposed but unproven immunomodulatory effects) alongside their standard immunotherapy regimen. No chemotherapy, radiotherapy, or recent immunomodulatory agents are allowed prior to enrollment.

ClinicalTrials.gov ID: NCT05967533

Allogeneic Stem Cell Transplantation Utilizing Alpha/Beta T Cell and CD19+ B Cell Depletion With Zoledronic Acid in Combination to Treat Pediatric, Adolescent, and Young Adult Patients With Relapsed/Refractory Solid Tumors

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: Pediatric, adolescent, and young adult patients (6 months–25 years) with relapsed/refractory high-risk solid tumors undergo haploidentical allogeneic HSCT using αβ T-cell and CD19+ B-cell–depleted grafts, with adjunct zoledronic acid. Zoledronic acid, a nitrogen-containing bisphosphonate that inhibits farnesyl pyrophosphate synthase and activates γδ T cells, is used to enhance graft-versus-tumor effects.

ClinicalTrials.gov ID: NCT06625190

Immunotherapy For Adults With GPC3-Positive Solid Tumors Using Interleukin-15 And -21 Armored Glypican-3-Specific Chimeric Antigen Receptor Expressing Autologous T Cells

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 GPC3-positive solid tumors (notably HCC; centrally confirmed by IHC) after standard therapies receive autologous GPC3-targeted CAR T cells armored with IL-15 and IL-21 to enhance expansion/persistence, incorporating an inducible caspase-9 safety switch, following cyclophosphamide/fludarabine lymphodepletion. Optional second infusion at 4 weeks if no progression.

ClinicalTrials.gov ID: NCT06198296

Interleukin-15 and -21 Armored Glypican-3-specific Chimeric Antigen Receptor Expressing Autologous T Cells as an Immunotherapy for Children With Solid Tumors (CARE)

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: Children and young adults (1–21 years) with relapsed/refractory GPC3-positive solid tumors (including HCC) receive cyclophosphamide/fludarabine lymphodepletion followed by a single infusion of autologous GPC3-targeted CAR T cells co-expressing IL-15 and IL-21, with an inducible caspase-9 safety switch. The investigational CAR targets the tumor proteoglycan GPC3, with IL-15/IL-21 “armoring” intended to enhance T-cell expansion and persistence.

ClinicalTrials.gov ID: NCT04715191