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NCT07188896 · ClinicalTrials.gov registry record · Phase 2
A Randomized Trial of Fianlimab and Cemiplimab +/- Ipilimumab or Ipilimumab Plus Nivolumab in First-line Advanced Renal Cell Carcinoma (RCC)
A Phase 2 study of Clear Cell Renal Cell Carcinoma (ccRCC) and Metastatic Renal Cell Carcinoma ( mRCC), sponsored by Brian Rini.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT07188896: Recruiting Phase 2 study of Clear Cell Renal Cell Carcinoma (ccRCC) and Metastatic Renal Cell Carcinoma ( mRCC), sponsored by Brian Rini.
NCT07188896 is a Phase 2 study of Clear Cell Renal Cell Carcinoma (ccRCC) and Metastatic Renal Cell Carcinoma ( mRCC) that is actively recruiting participants, run by Brian Rini. The registered enrollment target is 120 participants, below the 463-participant average among 5 other Clear Cell Renal Cell Carcinoma (ccRCC) trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07188896, a Phase 2 study of Clear Cell Renal Cell Carcinoma (ccRCC) and Metastatic Renal Cell Carcinoma ( mRCC), is actively recruiting participants, sponsored by Brian Rini.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
ORR is defined as confirmed complete response (CR) + confirmed partial response (PR) and will be determined as per RECIST 1.1.
Conditions Studied
Interventions
- DRUG Cemiplimab
- DRUG Nivolumab
- DRUG Ipilimumab
- DRUG Fianlimab
Study Locations (1)
Tennessee
- Vanderbilt-Ingram Cancer Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2026-03 |
| Est. Completion | 2030-11 |
| Phase | Phase 2 |
What NCT07188896 shows while recruiting
NCT07188896 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 463-participant average among 5 other Clear Cell Renal Cell Carcinoma (ccRCC) trials with a reported enrollment target (74% lower).
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.
NCT07188896 reports a single indexed study location in Tennessee.
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).
What interventions are being tested in trial NCT07188896?
The interventions under investigation include: Cemiplimab (DRUG), Nivolumab (DRUG), Ipilimumab (DRUG), Fianlimab (DRUG).
Who is sponsoring clinical trial NCT07188896?
This trial is sponsored by Brian Rini, which has 1 total clinical trials registered on ClinicalTrials.gov.
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.
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