Is NCT07188896 recruiting in Nashville, TN?

Yes, NCT07188896 is currently recruiting participants at its Nashville, TN location. This advanced renal cell carcinoma (arcc) clinical trial is actively enrolling qualified participants.

Is participation in this Nashville clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Advanced Renal Cell Carcinoma (aRCC) Clinical Trial in Nashville, TN

Q: How do I join the advanced renal cell carcinoma (arcc) clinical trial in Nashville?

To join this clinical trial in Nashville, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Advanced Renal Cell Carcinoma (aRCC) Study in Nashville

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.

Sponsor: Brian Rini

Who Can Participate

Inclusion 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 with an associated pathology report. If the metastatic lesion biopsy specimen does not contain at least 20 unstained slides, supplementation with primary kidney cancer tissue is acceptable.

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 father a child who are sexually active with a female of childbearing potential must be willing to abstain from penile-vaginal intercourse or use an effective method(s) of contraception.

Known HIV-infected subjects 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 this trial. Testing is not required at screening unless mandated by local policy

Subjects 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.

Subjects 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 subjects with HCV infection who are currently on treatment, the HCV viral load must be undetectable to be eligible for this trial. Testing is not required at screening unless mandated by local policy.

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.

Exclusion Criteria

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 hypothyroidism that requires only hormone replacement, psoriasis not requiring systemic treatment.

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 efficacy assessment of the investigational regimen, per treating physician discretion.

Subjects 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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Nashville?

Yes, this clinical trial (NCT07188896) has an active research site in Nashville, TN that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Advanced Renal Cell Carcinoma (aRCC) Treatment Options in Nashville, TN

If you're searching for advanced renal cell carcinoma (arcc) treatment options in Nashville, TN, this clinical trial (NCT07188896) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Nashville research site is actively enrolling participants for this clinical trial. You'll receive care from experienced advanced renal cell carcinoma (arcc) specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all advanced renal cell carcinoma (arcc) clinical trials near you to find additional studies recruiting in your area.

Advanced Renal Cell Carcinoma (aRCC) Clinical Trial in Nashville, TN

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