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New treatment option for Renal Cell Carcinoma
Official title A Study of Cemiplimab and Fianlimab in People With Clear Cell Renal Cell Carcinoma
ClinicalTrials.gov ID: NCT06699602
What this study is testing
What is Cemiplimab?
Cemiplimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for renal cell carcinoma.
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
- The researchers are doing this study to find out whether it is practical (feasible) to give cemiplimab and fianlimab before a nephrectomy and whether it causes any delays with surgery in people with kidney cancer. The researchers will also look at whether cemiplimab and fianlimab given before a nephrectomy is a safe and effective treatment approach and if there is a change in the size of the tumor following immunotherapy prior to planned surgery.
- Phase 2: a mid-size study of how well it works
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
- Age ≥ 18 years at the time of informed consent.
- Patient must be able to provide informed consent, or a legal authorized representative (LAR) must be identified to provide consent in cases where the...
- Signed and dated IRB-approved Informed Consent Form
- Patients must be planned for nephrectomy for high risk non-metastatic clear cell renal cell carcinoma.
- Non-metastatic disease will be defined by no evidence of metastases other than regional lymphadenopathy as assessed by imaging of the chest, abdomen...
You likely can't join if
- Prior receipt of any systemic therapy for renal cell carcinoma.
- Prior receipt of any immune checkpoint inhibitor therapy for any indication.
- Inability to safely delay surgery by 9 weeks as per surgeon's discretion.
- Patients who are receiving any other investigational agents.
- History of allergic reactions or known hypersensitivity attributed to the active substances or to any of the excipients
- History of severe hypersensitivity reaction to any monoclonal antibody.
See the full eligibility criteria
Who can join
- Age ≥ 18 years at the time of informed consent.
- Patient must be able to provide informed consent, or a legal authorized representative (LAR) must be identified to provide consent in cases where the patient cannot.
- Signed and dated IRB-approved Informed Consent Form
- Patients must be planned for nephrectomy for high risk non-metastatic clear cell renal cell carcinoma.
- Non-metastatic disease will be defined by no evidence of metastases other than regional lymphadenopathy as assessed by imaging of the chest, abdomen and pelvis with CT of the chest and MR of the abdomen/pelvis (CT...
- 'High-risk non-metastatic' is defined as those patients with a 12-year probability of metastases of ≥ 30% as per an established pre-operative nomogram
- Patients must undergo baseline biopsy to confirm clear cell histology prior to treatment initiation.
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Patients must have adequate organ and bone marrow function, defined by the following laboratory results obtained within 14 days prior to the first study treatment: i. ANC ≥ 1500 cells/μL (without granulocyte colony...
What rules you out
- Prior receipt of any systemic therapy for renal cell carcinoma.
- Prior receipt of any immune checkpoint inhibitor therapy for any indication.
- Inability to safely delay surgery by 9 weeks as per surgeon's discretion.
- Patients who are receiving any other investigational agents.
- History of allergic reactions or known hypersensitivity attributed to the active substances or to any of the excipients
- History of severe hypersensitivity reaction to any monoclonal antibody.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring therapy, symptomatic congestive heart failure, unstable angina pectoris, or uncontrolled cardiac arrhythmia.
- Patients with a history of myocarditis.
- Patients with Troponin TnT or troponin I TnI \> 2x institutional ULN at baseline. ° Patients with TnT or TnI levels between \> 1 to 2x ULN are permitted if repeat levels within 24 hours are ≤ 1x ULN. If TnT or TnI...
- Patients with active autoimmune disease or recent history (within 2 years) of autoimmune disease that might recur, which may affect vital organ function, or require immune suppressive treatment including systemic...
- Patients should be excluded if they have a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of study drug administration. Patients are permitted to...
- Diagnosis of another malignancy within 2 years before first dose of study treatment, except for superficial skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy.
- Prior allogeneic stem cell transplant or solid organ transplant.
- History or current evidence of significant (CTCAE grade ≥2) local or systemic infection (eg, cellulitis, pneumonia, septicemia) requiring systemic antibiotic treatment within 2 weeks prior to the first dose of trial...
- Use of live vaccines against infectious disease (e.g. varicella) within 30 days of initiation of study therapy. Killed vaccinations (e.g. influenza) are allowed at any appropriate time before and during the study. If a...
- Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus (HBV or HCV) infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection.
- Patients with known HIV infection who have controlled infection (undetectable viral load on HIV RNA PCR) and CD4 count above 350 (either spontaneously or on a stable antiviral regimen) are permitted. For patients with...
- Patients with HBV (hepatitis B surface antigen positive; HBsAg+) who have controlled infection (serum HBV DNA PCR that is below the limit of detection and receiving anti-viral therapy for HBV) are permitted. Patients...
- Patients who are HCV antibody positive (HCV Ab+) who have controlled infection (undetectable HCV RNA by PCR, either spontaneously or in response to successful prior course of anti-HCV therapy) are permitted.
- Patients with HIV or hepatitis must be reviewed by a qualified specialist (eg, infectious disease or hepatologist) managing this disease prior to commencing and regularly throughout the duration of their participation...
- Women with a positive serum beta-hCG pregnancy test at screening/baseline visit. If positive, pregnancy must be ruled out by ultrasound for patient to be eligible.
- Breast-feeding women.
- Women of childbearing potential (WOCBP) who are sexually active and are not willing to practice highly effective contraception prior to the first treatment, during the study, and for at least 6 months after the last...
- stable use of combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition...
- intrauterine device; intrauterine hormone-releasing system;
- bilateral tubal occlusion/ligation;
- vasectomized partner (provided that the male vasectomized partner is the sole sexual partner of the WOCBP study participant and that the vasectomized partner has obtained medical assessment of surgical success for the...
- sexual abstinence - Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study drugs. The reliability...
- Male study participants with WOCBP partners are required to use condoms during the study and until 6 months after the last dose of study treatment unless they are vasectomized or practice sexual abstinence.
- WOCBP must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the entire trial and until 6 months after last treatment.
- All men must agree not to donate sperm during the trial and for 6 months after receiving the last therapy dose.
The study team makes the final eligibility decision.
Where it's taking place
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, 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 Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 1 more location(s). 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.