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RECRUITING Phase 2

A Randomized Trial of Fianlimab and Cemiplimab +/- Ipilimumab or Ipilimumab Plus Nivolumab in First-line Advanced Renal Cell Carcinoma (RCC)

NCT07188896 · View on ClinicalTrials.gov ↗

Study Summary

This three-arm randomized phase 2 trial will enroll advanced clear cell RCC patients (all IMDC risk groups). Patients will be randomized 2:2:1 to either Arm A (fianlimab/ cemiplimab/ ipilimumab), Arm B (fianlimab/ cemiplimab), or Arm C (standard ipilimumab/ nivolumab), respectively.

Interventions

  • DRUG Cemiplimab
  • DRUG Nivolumab
  • DRUG Ipilimumab
  • DRUG Fianlimab

Study Locations (1)

Tennessee

  • Vanderbilt-Ingram Cancer Center — Nashville

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2026-03
Est. Completion 2030-11
Phase Phase 2

Sponsor

Brian Rini

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07188896

The ClinicalTrials.gov registry entry for NCT07188896 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brian Rini, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Clear Cell Renal Cell Carcinoma (ccRCC) appearing as the primary indexed condition, and to 4 interventions — of which Cemiplimab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07188896 reports 1 study location spanning 1 distinct geographic area — top geographies include Tennessee. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT07188896 about?

NCT07188896 is a clinical study titled "A Randomized Trial of Fianlimab and Cemiplimab +/- Ipilimumab or Ipilimumab Plus Nivolumab in First-line Advanced Renal Cell Carcinoma (RCC)". This three-arm randomized phase 2 trial will enroll advanced clear cell RCC patients (all IMDC risk groups). Patients will be randomized 2:2:1 to either Arm A (fianlimab/ cemiplimab/ ipilimumab), Arm B (fianlimab/ cemiplimab), or Arm C (standard ipilimumab/ nivolumab), respectively.

What is the current status of trial NCT07188896?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2026-03. Estimated completion is 2030-11.

What conditions does trial NCT07188896 study?

This clinical trial studies the following conditions: Clear Cell Renal Cell Carcinoma (ccRCC), Metastatic Renal Cell Carcinoma ( mRCC), Advanced Renal Cell Carcinoma (aRCC). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07188896?

The interventions under investigation include: Cemiplimab (DRUG), Nivolumab (DRUG), Ipilimumab (DRUG), Fianlimab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07188896?

This trial is sponsored by Brian Rini, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT07188896 being conducted?

This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial