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New treatment option for Renal Cell Carcinoma, Clear Cell
Official title A Randomized Phase 2 Trial of Nivolumab, Relatlimab Plus Ipilimumab vs. Nivolumab Plus Ipilimumab in First-line Advanced Renal Cell Carcinoma (RCC)
ClinicalTrials.gov ID: NCT06708949
What this study is testing
What is Drugs Nivolumab?
Drugs Nivolumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for renal cell carcinoma, clear cell.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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)
See the full eligibility criteria
- 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%.
- 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 \ 30 mL/min (measured or calculated by Cockroft-Gault formula)
- Total bilirubin ≤ 1.5 x ULN (except people 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...
- "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...
- 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.
- 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)
- 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, people are permitted the use of corticosteroids with minimal systemic absorption (e.g. topical, ocular, intra-articular, intranasal, and inhalational) ≤ 10 mg/day prednisone...
- Active, known or suspected autoimmune disease (see Appendix 1 for a comprehensive list of autoimmune diseases and immune deficiencies).
- people 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...
- 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...
- 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...
- Treatment with any live/attenuated vaccine within 30 days of first study treatment
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- Durham, North Carolina, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; Durham, North Carolina, United States; Philadelphia, Pennsylvania, United States; Nashville, Tennessee, United States; Dallas, Texas, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.