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Phase 2 Study for Advanced Kidney Cancer (RCC)

This study is testing two different combinations of medicines for advanced kidney cancer (renal cell carcinoma or RCC) that has spread. You would receive either nivolumab, relatlimab, and ipilimumab, or nivolumab and ipilimumab. These medicines are given through an IV. The main goal is to see how safe these combinations are and what side effects they might cause. Researchers will also look at how well the treatments work. You could join if you are 18 or older, have clear cell RCC that has spread, and have not had other treatments for your advanced cancer. About 15 people are expected to join this study. The current status of this study is unclear.

Study design
This is a phase 2 study where participants are randomly assigned to one of two treatment groups. It is a multicenter study, meaning it takes place at several locations, and plans to enroll about 15 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety and side effects will be monitored throughout the study, which is expected to last an average of 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06708949

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~15 participants
Updated 2026-05-14 on ClinicalTrials.gov
What's tested:Drugs NivolumabIpilimumabBMS-986213 (Relatlimab-Nivolumab FDC)

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Averse events (AEs)
Measured over Through study completion; an average of 1 year

Conditions

Renal Cell Carcinoma, Clear Cell

Explore related trials

Renal Cell Carcinoma

Where it's being run

6 sites across 5 states
Texas2
Massachusetts1
North Carolina1
Pennsylvania1
Tennessee1

Study leadership

  • Eric Jonasch, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Eric Jonasch, MD
[email protected]
(713) 563-7232
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 9. Women must not be breastfeeding while taking the study drug and for up to five months after the last dose of study drug 10. 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. 11. 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.

Exclusion

Radiosurgery or radiotherapy
Minor surgery. (Note: Placement of a vascular access device is not considered minor or major surgery)
Active infection requiring infusion treatment. 4. Any history of or current CNS metastases 5. 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.

What this trial measures

  • Safety and Averse events (AEs)Through study completion; an average of 1 year

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