Is NCT07510334 recruiting in Rochester, MN?

Yes, NCT07510334 is currently recruiting participants at its Rochester, MN location. This advanced clear cell renal cell carcinoma clinical trial is actively enrolling qualified participants.

Is participation in this Rochester 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 Clear Cell Renal Cell Carcinoma Clinical Trial in Rochester, MN

Q: How do I join the advanced clear cell renal cell carcinoma clinical trial in Rochester?

To join this clinical trial in Rochester, 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 Clear Cell Renal Cell Carcinoma Study in Rochester

This phase II trial tests adding VSV-IFNβ-NIS to standard of care ipilimumab and nivolumab for the treatment of clear cell renal cell carcinoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). A virus modified in the laboratory, such as VSV-IFNβ-NIS, may be able to kill tumor cells without damaging normal cells. Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving VSV-IFNβ-NIS with ipilimumab and nivolumab may be effective for the treatment of advanced or metastatic clear cell renal cell carcinoma.

Sponsor: Mayo Clinic

Who Can Participate

Inclusion Criteria

Age ≥ 18 years

Disease Characteristics:

Histological confirmation of advanced (not amenable to curative surgery or radiation therapy) or metastatic \[American Joint Committee on Cancer (AJCC) version 8 Stage IV\] renal cell carcinoma (RCC) with a clear cell component, including all International Metastatic RCC Database Consortium (IMDC) risk categories (favorable, intermediate, and poor risk) allowed

Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

NOTE: Liver lesions that have been previously embolized (bland embolization, chemo- or radio-embolization) or have undergone percutaneous thermoablation are not eligible as target lesions. Tumor lesions in a previously irradiated area are not considered measurable disease; disease that is measurable by physical examination only is not eligible

Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2

Hemoglobin ≥ 9.0 g/dL (obtained ≤ 15 days prior to registration)

Absolute neutrophil count (ANC) ≥ 1500/mm\^3 (obtained ≤ 15 days prior to registration)

Platelet count ≥ 100,000/mm\^3 (obtained ≤ 15 days prior to registration)

Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (obtained ≤ 15 days prior to registration)

Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement) (obtained ≤ 15 days prior to registration)

Prothrombin time (PT)/international normalization ratio (INR)/activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN OR if patient is receiving anticoagulant therapy and INR or aPTT is within target range of therapy (≤ 5 x ULN for patients with liver involvement) (obtained ≤ 15 days prior to registration)

Serum creatinine ≤ 1.5 x upper limit of normal (ULN) OR creatinine clearance ≥ 50 ml/min using the chronic kidney disease epidemiology (CKD-EPI) creatinine equation (per National Kidney Foundation) (obtained ≤ 15 days prior to registration)

NOTE: See calculator at National Kidney Foundation website here: https://www.kidney.org/professionals/kdoqi/gfr\_calculator

Negative pregnancy test done ≤ 8 days prior to registration, for persons of childbearing potential only

Provide written informed consent

Willingness to provide mandatory blood specimens for correlative research

Willingness to provide mandatory tissue specimens for correlative research

Willing to return to Mayo Clinic for follow-up (during the active monitoring phase of the study)

Exclusion Criteria

Any of the following because this study involves an investigational agent, the genotoxic, mutagenic and teratogenic effects of which on the developing fetus and newborn are unknown:

Pregnant persons

Nursing persons

Persons of childbearing potential and persons able to father a child who are unwilling to employ adequate contraception

Prior treatment for advanced or metastatic RCC \[American Joint Committee on Cancer (AJCC) Stage IV\]

History of portal vein thrombosis involving more than intrahepatic portal vein branches: thrombosis of the right or left portal vein branch or the bifurcation, partial or complete obstruction of the portal vein trunk

NOTE: Level 0 or 1 tumor thrombus remain eligible; Level 2, 3, of 4 tumor thrombus related to the primary kidney tumor are ineligible

Has received a live vaccine ≤ 30 days prior to registration

NOTE: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines and are NOT allowed

Any of the following prior therapies:

Surgery ≤ 3 weeks prior to registration

Chemotherapy ≤ 2 weeks prior to registration

Radiation therapy ≤ 2 weeks prior to registration

Therapy in the first-line setting for advanced or metastatic RCC

Adjuvant immunotherapy during which or in the ≤ 6 months immediately following, relapse or disease progression has occurred

New York Heart Association classification III or IV, known symptomatic coronary artery disease, or symptoms of coronary artery disease on systems review, or known cardiac arrhythmias \[atrial fibrillation or supraventricular tachycardia (SVT)\]

Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens

Uncontrolled intercurrent illness including, but not limited to:

ongoing or active infection

symptomatic congestive heart failure

unstable angina pectoris

cardiac arrhythmia

dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy

or psychiatric illness/social situations that would limit compliance with study requirements

Current immunodeficiency or immunosuppression and receiving systemic corticosteroids at \> 10mg/day prednisone or equivalent ≤ 1 week prior to registration.

NOTE: Inhaled steroids for pulmonary disease are permitted

Known history of the following:

Suspected active organ-threatening autoimmune disease including, but not limited to, inflammatory bowel disease, autoimmune hepatitis, lupus, or pneumonitis which can flare while receiving immune checkpoint inhibitor (ICI) treatment.

NOTE: Patients with well-controlled or clinically inactive autoimmune diseases are eligible

Non-infectious pneumonitis that required steroids, current pneumonitis, carcinomatous meningitis, or interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity

Known or ongoing illness or infection including:

Any active Grade 3 or higher \[per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version (v) 5.0\] viral, bacterial, or fungal infection ≤ 2 weeks of registration.

Acute hepatitis B (HBV) or acute hepatitis C virus (HCV)

NOTE: Patients with chronic HBV or HCV with adequate liver function per inclusion criteria are still eligible

Patients known to be HIV positive and currently receiving antiretroviral therapy

Known history of active tuberculosis (TB) (bacillus tuberculosis)

Uncontrolled hypertension and/or diabetes

Clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease requiring hospitalization ≤ 3 months prior to treatment)

Receiving concurrent anti-cancer therapy (chemotherapy, immunotherapy, radiotherapy, or any other investigational agent or therapy considered investigational (used for a non-Food and Drug Administration (FDA) approved indication and in the context of a research investigation)

Known concurrent malignancy that is progressing or requires active treatment

EXCEPTIONS: basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in-situ cervical cancer that has been treated with curative intent, prostate cancer confined to the prostate gland with Gleason score ≤ 6, as well as any cancer treated with curative intent or any prior cancer with a disease-free interval of ≥ 3 years

History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias

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 Rochester?

Yes, this clinical trial (NCT07510334) has an active research site in Rochester, MN 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 Clear Cell Renal Cell Carcinoma Treatment Options in Rochester, MN

If you're searching for advanced clear cell renal cell carcinoma treatment options in Rochester, MN, this clinical trial (NCT07510334) 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 Rochester research site is actively enrolling participants for this clinical trial. You'll receive care from experienced advanced clear cell renal cell carcinoma 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 clear cell renal cell carcinoma clinical trials near you to find additional studies recruiting in your area.

Advanced Clear Cell Renal Cell Carcinoma Clinical Trial in Rochester, MN

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