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AzTrials

Renal Cell Carcinoma, Clear CellPhase 2NCT06708949

A Randomized Phase 2 Trial of Nivolumab, Relatlimab Plus Ipilimumab vs. Nivolumab Plus Ipilimumab in First-line Advanced Renal Cell Carcinoma (RCC)

A Phase 2 study testing Drugs Nivolumab, Ipilimumab and BMS-986213 (Relatlimab-Nivolumab FDC) in people with Renal Cell Carcinoma, Clear Cell, run by M.D. Anderson Cancer Center at 6 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a phase 2 stratified, randomized, multicenter, study investigating the efficacy of a triplet arm treating with nivolumab 480 mg every 4 weeks (Q4W), relatlimab 160 mg Q4W and ipilimumab 1 mg/kg every 8 weeks (Q8W) intravenous (IV) versus a doublet arm treating with nivolumab 480 mg Q3W and ipilimumab 1mg/kg… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Cell Carcinoma, Clear Cell
What is being tested?
Drugs Nivolumab, Ipilimumab and BMS-986213 (Relatlimab-Nivolumab FDC)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
6 sitesUnited States
Study dates
20 Mar 2025to 15 Dec 2028
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

  • Willing and able to provide a signed and dated written informed consent.
  • ≥ 18 years of age
  • Confirmed diagnosis of RCC with a clear cell component
  • Stage IV metastatic renal cell carcinoma per American Joint Committee on Cancer
  • No prior systemic therapy for RCC. Prior neo/adjuvant systemic therapy is not allowed.
  • Karnofsky performance status ≥ 70%.
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  • At least one measurable lesion as defined by RECIST 1.1 (Appendix 3)
  • A tumor lesion situated in a previously irradiated area is considered a measurable/target lesion only if subsequent disease progression has been documented in the lesion
  • Adequate organ function within 28 days prior to first dose of protocol-indicated treatment, including:
  • White blood cell (WBC) ≥ 2,000 /µL
  • Absolute neutrophil count (ANC) ≥ 1,500/µL
  • Platelets ≥ 100,000/µL
  • Serum creatinine < 1.5 x upper limit of normal (ULN) or creatinine clearance > 30 mL/min (measured or calculated by Cockroft-Gault formula)
  • Total bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who must have total bilirubin < 3.0 mg/dL)
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN
  • Women must not be breastfeeding while taking the study drug and for up to five months after the last dose of study drug
  • Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 24 hours prior to receiving first dose of protocol-indicated treatment. An extension up to 72 hours prior to the start of study treatment is permissible in situations where results cannot be obtained within the standard 24-hour window.
  • "Women of childbearing potential" (WOCBP) is defined as any female who has experienced menarche who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or is not postmenopausal.
  • Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 years of age in the absence of other biological or physiological causes.
  • If menopausal status is considered for the purpose of evaluating childbearing potential, women < 62 years of age must have a documented serum follicle stimulating hormone (FSH) level within laboratory reference range for postmenopausal women, in order to be considered postmenopausal and not of childbearing potential.
  • Women of childbearing potential (WOCBP) must agree to follow instructions for acceptable contraception Appendix 5 from the time of signing consent, and for 23 weeks after their last dose of protocol-indicated treatment.

Who cannot join

  • Prior systemic treatment for RCC of any type including neoadjuvant or adjuvant therapy is not allowed.
  • ≤ 28 days before first dose of protocol-indicated treatment:
  • Major surgery requiring general anesthesia.
  • ≤ 14 days before first dose of protocol-indicated treatment:
  • Radiosurgery or radiotherapy
  • Minor surgery. (Note: Placement of a vascular access device is not considered minor or major surgery)
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  • Active infection requiring infusion treatment.
  • Any history of or current CNS metastases
  • Any condition requiring systemic treatment with either corticosteroids (> 10 mg/day prednisone or equivalent daily) or other immunosuppressive medications within 14 days prior to initiating protocol-indicated treatment.
  • In the absence of active autoimmune disease, subjects are permitted the use of corticosteroids with minimal systemic absorption (e.g. topical, ocular, intra-articular, intranasal, and inhalational) ≤ 10 mg/day prednisone or equivalent daily; and physiologic replacement doses of systemic corticosteroids ≤ 10 mg/day prednisone or equivalent daily (e.g. hormone replacement therapy needed in patients with hypophysitis)
  • Active, known or suspected autoimmune disease (see Appendix 1 for a comprehensive list of autoimmune diseases and immune deficiencies).
  • Subjects with type I diabetes mellitus; endocrine organ dysfunction (e.g., hypothyroidism) that are controlled and only requiring only hormone replacement; skin disorders such as vitiligo, psoriasis or alopecia not requiring systemic treatment; or conditions not expected by the investigator to recur in the absence of an external trigger are permitted to enroll.
  • Known psychiatric condition, social circumstance, or other medical condition reasonably judged by the investigator to unacceptably increase the risk of study participation; or to prohibit the understanding or rendering of informed consent or anticipated compliance with and interpretation of scheduled visits, treatment schedule, laboratory tests and other study requirements.
  • History of myocarditis, regardless of etiology
  • Troponin T (TnT) or I (TnI) > 2× institutional upper limit of normal (ULN)
  • Participants with TnT or TnI levels between > 1× to 2× ULN will be permitted if repeat levels within 24 hours are ≤ 1× ULN. If TnT or TnI levels are between > 1× to 2× ULN within 24 hours, the participant may undergo a cardiac evaluation and be considered for treatment, based on a favorable benefit/risk assessment by the Investigator.
  • When repeat levels within 24 hours are not available, a repeat test should be conducted as soon as possible. If TnT or TnI repeat levels beyond 24 hours are < 2× ULN, the participant may undergo a cardiac evaluation and be considered for treatment, based on a favorable benefit/risk assessment by the Investigator.
  • Treatment with any live/attenuated vaccine within 30 days of first study treatment

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • The University of Texas M. D. Anderson Cancer Center

    Houston, Texas, 77030

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Penn Medicine Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

This is a phase 2 stratified, randomized, multicenter, study investigating the efficacy of a triplet arm treating with nivolumab 480 mg every 4 weeks (Q4W), relatlimab 160 mg Q4W and ipilimumab 1 mg/kg every 8 weeks (Q8W) intravenous (IV) versus a doublet arm treating with nivolumab 480 mg Q3W and ipilimumab 1mg/kg Q3W IV in first-line advanced RCC.

Read the detailed description

Primary Objectives:

To determine the safety and tolerability of nivolumab, relatlimab and ipilimumab in patients with untreated advanced RCC

  • To assess the ORR of nivolumab, relatlimab and ipilimumab in patients with untreated advanced RCC
Being tested
Drugs Nivolumab, Ipilimumab, BMS-986213 (Relatlimab-Nivolumab FDC)
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.

  • Drugs NivolumabDrug

    Given by IV Infusion

  • IpilimumabDrug

    Given by IV Infusion

  • BMS-986213 (Relatlimab-Nivolumab FDC)Drug

    Given by IV Infusion

Study groups in NCT06708949
Study groupRoleWhat they receive
Treatment with Nivolumab + IpilimumabExperimentalParticipants will randonmized to study and treatment will be administered on an outpatient basis.
Receives: Drug: Drugs Nivolumab; Drug: Ipilimumab
Treatment with Nivolumab + Relatlimab + IpilimumabExperimentalParticipants will randonmized to study and treatment will be administered on an outpatient basis.
Receives: Drug: Ipilimumab; Drug: BMS-986213 (Relatlimab-Nivolumab FDC)

What is being measured

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

  1. Safety and Averse events (AEs)

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

    Measured: Through study completion; an average of 1 year

Timeline

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

  1. First posted29 Nov 2024
  2. Study start20 Mar 2025
  3. Primary completion15 Dec 2028 (estimated)
  4. Study completion15 Dec 2028 (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
Single group
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06708949
Sponsor's protocol ID
2024-1337
Other IDs
NCI-2025-01553
Status last verified
Sep 2026
First submitted
25 Nov 2024
Last updated
11 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 Drugs Nivolumab, Ipilimumab and BMS-986213 (Relatlimab-Nivolumab FDC) in people with Renal Cell Carcinoma, Clear Cell, run by M.D. Anderson Cancer Center at 6 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 21 inclusion and 18 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: under way, not looking for participants, as of the sponsor's last update on 11 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 6 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Averse events (AEs) (time frame: Through study completion; an average of 1 year). 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 NCT06708949.

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 11 Sep 2026.

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