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

NCT07188896 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-05-01

No results posted yet for this 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.

Conditions

  • Advanced Renal Cell Carcinoma (aRCC)
  • Metastatic Renal Cell Carcinoma ( mRCC)
  • Clear Cell Renal Cell Carcinoma (ccRCC)

Interventions

DRUG

Fianlimab

Fianlimab will be co-administered by IV.

DRUG

Ipilimumab

Ipilimumab will be administered by IV.

DRUG

Nivolumab

Nivolumab will be administered by IV. Maintenance nivolumab will then be administered by IV.

DRUG

Cemiplimab

Cemiplimab will co-administered by IV.

Sponsors & Collaborators

Principal Investigators

  • Brian Rini, MD · Vanderbilt-Ingram Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-29
Primary Completion
2029-11-30
Completion
2030-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07188896 on ClinicalTrials.gov