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Advanced Renal Cell Carcinoma (aRCC)Phase 2NCT07188896

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

A Phase 2 study testing Fianlimab, Ipilimumab and Nivolumab in people with Advanced Renal Cell Carcinoma (aRCC) and Metastatic Renal Cell Carcinoma ( mRCC), run by Brian Rini at 5 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Fianlimab, Ipilimumab and Nivolumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
5 sitesUnited States
Study dates
29 Apr 2026to 30 Nov 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
  • Age ≥ 18 years at the time of consent.
  • Karnofsky Performance Status ≥ 70% within 14 days prior to registration.
  • Histological or cytological evidence of renal cell carcinoma having a clear cell component
  • Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV [version 9]) renal cell carcinoma.
  • Treatment naïve for systemic therapy for renal cell carcinoma including no prior neo/adjuvant systemic therapy
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  • Measurable disease according to RECIST 1.1 within 28 days prior to registration.
  • Patient must have either a formalin-fixed, paraffin-embedded (FFPE) tissue block or unstained tumor tissue sections, obtained from preferably a metastatic lesion, preferably within 3 months or no more than 12 months with an associated pathology report. If the metastatic lesion biopsy specimen does not contain at least 20 unstained slides, supplementation with primary kidney cancer tissue is acceptable.
  • Demonstrate adequate organ function as defined in the protocol. All screening labs to be obtained within 14 days prior to registration.
  • Females of childbearing potential must have a negative serum pregnancy test within 14 days prior to registration.
  • Females of childbearing potential who are sexually active with a male able to father a child must be willing to abstain from penile-vaginal intercourse or must use an effective method(s) of contraception. Males able to father a child who are sexually active with a female of childbearing potential must be willing to abstain from penile-vaginal intercourse or use an effective method(s) of contraception.
  • Known HIV-infected subjects on effective anti-retroviral therapy with undetectable viral load and CD4 count above 350 either spontaneously or on a stable antiviral regimen within 6 months of registration are eligible for this trial. Testing is not required at screening unless mandated by local policy
  • Subjects with known chronic hepatitis B virus (HBV) infection, must have an undetectable HBV viral load (serum hepatitis B virus DNA PCR that is below the limit of detection) and be on suppressive therapy, if indicated.
  • Subjects with a history of hepatitis C virus (HCV) infection must have been treated and cured (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy). For subjects with HCV infection who are currently on treatment, the HCV viral load must be undetectable to be eligible for this trial. Testing is not required at screening unless mandated by local policy.
  • As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.

Who cannot join

  • Prior systemic therapy against renal cell carcinoma in the neo/adjuvant or metastatic setting
  • Any condition requiring ongoing ≥ 10 mg prednisone equivalent/day
  • Participants with a history of myocarditis.
  • If clinically indicated based on clinical assessment and any ECG abnormalities, optional troponin T (TnT) or troponin I (TnI) may be done as described in the protocol.
  • Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents. The following are allowed: vitiligo, childhood asthma that has resolved, residual hypothyroidism that requires only hormone replacement, psoriasis not requiring systemic treatment.
  • Central nervous system (CNS) metastases as described in the protocol.
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  • Active infection requiring systemic therapy as described in the protocol.
  • Pregnant or breastfeeding as described in the protocol.
  • Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen, per treating physician discretion.
  • Subjects must not receive live attenuated vaccines within 4 weeks prior to Cycle 1 Day 1 or at any time during the study. Inactivated vaccines are allowed.
  • Known hypersensitivity to the active substances or to any of the excipients.
  • Currently participating in another study or participated in any study of an investigational agent or investigational device within 30 days of the first dose of study drug.

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Brian Rini, MD contact

615-936-8422

brian.rini@vumc.org

Allison Lipps contact

317-634-5842 ext. 40

alipps@hoosiercancer.org

5 sites in 1 country

United States5 sites, 5 recruiting

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

    Kate Ashcraft, PhD, 919-966-0807, kate_ashcraft@med.unc.edu

    Catherine Fahey, MD, PhD

    Recruiting

  • Penn State Cancer Institute

    Hershey, Pennsylvania, 17033

    Meredith Belga, RN, 717-531-5232, mbelga@pennstatehealth.psu.edu

    Stuthi Perimbeti, MBBS, MPH

    Recruiting

  • Froedtert and The Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Jaime Goeldner, 414-805-8943, jgoeldner@mcw.edu

    Deepak Kilari, MD

    Recruiting

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232

    Rebekah Caza, RN, MSN, 615-343-6584, rebekah.caza@vumc.org

    Brian Rini, MD

    Recruiting

  • Georgetown University

    Washington D.C., District of Columbia, 20057

    Jamie Manganti, BSN, RN, 202-687-3937, jm3821@georgetown.edu

    Michael Atkins, MD

    Recruiting

Other trials in United States

About this study

Official title: A Randomized Phase 2 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.

Being tested
Fianlimab, Ipilimumab, Nivolumab, Cemiplimab
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FianlimabDrug

    Fianlimab will be co-administered by IV.

  • IpilimumabDrug

    Also called Yervoy

    Ipilimumab will be administered by IV.

  • NivolumabDrug

    Also called Opdivo

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

  • CemiplimabDrug

    Cemiplimab will co-administered by IV.

Study groups in NCT07188896
Study groupRoleWhat they receive
Arm A: Cemiplimab, Fianlimab, and IpilimumabExperimentalCemiplimab and fianlimab will be co-administered by IV. Ipilimumab will be administered by IV.
Receives: Drug: Fianlimab; Drug: Ipilimumab; Drug: Cemiplimab
Arm B: Cemiplimab and FianlimabExperimentalCemiplimab and fianlimab will be co-administered by IV.
Receives: Drug: Fianlimab; Drug: Cemiplimab
Arm C: Nivolumab and IpilimumabActive comparatorNivolumab and ipilimumab will be by IV. Nivolumab will be administered by IV after the combination.
Receives: Drug: Ipilimumab; Drug: Nivolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    ORR is defined as confirmed complete response (CR) + confirmed partial response (PR) and will be determined as per RECIST 1.1.

    Measured: 2 years

Secondary outcomes (6)

  1. Median Progression Free Survival (PFS)

    PFS is defined as the time from Day 1 of treatment to the first documented disease progression per RECIST 1.1, clinically progressive disease per investigator, or death due to any cause, whichever occurs first.

    Measured: 5 years

  2. 12-month Progression Free Survival (PFS)

    PFS is defined as the time from Day 1 of treatment to the first documented disease progression per RECIST 1.1, clinically progressive disease per investigator, or death due to any cause, whichever occurs first.

    Measured: 12 months

  3. 24-month Progression Free Survival (PFS)

    PFS is defined as the time from Day 1 of treatment to the first documented disease progression per RECIST 1.1, clinically progressive disease per investigator, or death due to any cause, whichever occurs first.

    Measured: 24 months

  4. Duration of Response (DOR)

    DOR is defined as the time from first documented evidence of CR or PR per RECIST 1.1 until disease progression based on RECIST 1.1 or death due to any cause, whichever occurs first.

    Measured: 5 years

  5. Treatment Free Survival (TFS)

    TFS will be assessed based on the area between two time to event KM curves from the time of study treatment initiation to study treatment discontinuation and from study initiation to initiation of subsequent systemic anti-cancer treatment or death. Time on or off treatment with Grade 3 or greater treatment related toxicities per CTCAE v5 will be determined as the area between study initiation and toxicity start and study initiation and Grade 3 toxicity ending.

    Measured: 5 years

  6. Adverse Event Rates

    The frequency of subjects experiencing treatment related adverse events and SAEs graded per NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2025
  2. Study start29 Apr 2026
  3. Primary completion30 Nov 2029 (estimated)
  4. Study completion30 Nov 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07188896
Sponsor's protocol ID
HCRN GU23-651
Status last verified
Sep 2026
First submitted
16 Sep 2025
Last updated
4 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fianlimab, Ipilimumab and Nivolumab in people with Advanced Renal Cell Carcinoma (aRCC) and Metastatic Renal Cell Carcinoma ( mRCC), run by Brian Rini at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Brian Rini, MD (615-936-8422, brian.rini@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07188896.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.

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