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

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Brian Rini
Study ID
NCT07188896
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fianlimab — DRUG
    Fianlimab will be co-administered by IV.
  • Ipilimumab — DRUG
    Ipilimumab will be administered by IV.
  • Nivolumab — DRUG
    Nivolumab will be administered by IV. Maintenance nivolumab will then be administered by IV.
  • Cemiplimab — DRUG
    Cemiplimab will co-administered by IV.

Study Details

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.

Key Dates

Start date
Apr 29, 2026
Status verified
Apr 2026
Primary completion
Nov 30, 2029
Completion
Nov 30, 2030

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Cemiplimab, Fianlimab, and Ipilimumab
    Cemiplimab and fianlimab will be co-administered by IV. Ipilimumab will be administered by IV.
  • Experimental: Arm B: Cemiplimab and Fianlimab
    Cemiplimab and fianlimab will be co-administered by IV.
  • Active Comparator: Arm C: Nivolumab and Ipilimumab
    Nivolumab and ipilimumab will be by IV. Nivolumab will be administered by IV after the combination.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232
Rebekah Caza, RN, MSN
[email protected]
615-343-6584
Brian Rini, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Nashville, TN

By research site
Vanderbilt-Ingram Cancer Center· Nashville, TN

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