BridgeMD
New treatment option for Advanced Renal Cell Carcinoma (aRCC)
Official title A Randomized Trial of Fianlimab and Cemiplimab +/- Ipilimumab or Ipilimumab Plus Nivolumab in First-line Advanced Renal Cell Carcinoma (RCC)
ClinicalTrials.gov ID: NCT07188896
What this study is testing
What is Fianlimab?
Fianlimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced renal cell carcinoma (arcc).
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 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.
- 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
- Signed informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be...
- 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.
You likely can't join if
- 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...
- Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents. The following...
- Central nervous system (CNS) metastases as described in the protocol.
See the full eligibility criteria
- 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
- 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...
- 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...
- Known HIV-infected people 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...
- people 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.
- people 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 people...
- 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.
- 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...
- Central nervous system (CNS) metastases as described in the protocol.
- 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 how well it works assessment of the investigational regimen, per treating physician discretion.
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Nashville, Tennessee, United States
- Milwaukee, Wisconsin, 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 Nashville, Tennessee, United States; Milwaukee, Wisconsin, 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.