Is NCT07383441 recruiting in Springdale, AR?

Yes, NCT07383441 is currently recruiting participants at its Springdale, AR location. This advanced clear cell renal cell carcinoma clinical trial is actively enrolling qualified participants.

Is participation in this Springdale 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 Springdale, AR

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

To join this clinical trial in Springdale, 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 Springdale

This phase III trial compares the effect of adding live biotherapy, MO-03, to standard of care (SOC) immunotherapy, including ipilimumab, nivolumab, axitinib, pembrolizumab, cabozantinib, and lenvatinib, to SOC immunotherapy alone in treating patients with clear cell renal cell cancer that may have spread from where it first started (primary site) to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started to other places in the body (metastatic). Studies have shown that gut health (the gut microbiome) may impact the effectiveness of immunotherapy. The microbiome includes all of the bacteria and organisms naturally found in the digestive tract. MO-03, a type of biotherapy, contains material from living organisms that may help keep the digestive tract healthy and may help to increase the effect of immunotherapy. Immunotherapy with monoclonal antibodies, such as ipilimumab, nivolumab, pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Axitinib, cabozantinib, and lenvatinib are a type of angiogenesis inhibitor and tyrosine kinase inhibitor (TKI) that block certain proteins which may help keep tumor cells from growing and may also help prevent the growth of new blood vessels that tumors need to grow. Adding MO-03 to SOC immunotherapy may be more effective than SOC immunotherapy alone in treating patients with advanced or metastatic clear cell renal cell cancer.

Sponsor: SWOG Cancer Research Network

Who Can Participate

Inclusion Criteria

Participants must have histologically confirmed renal cell carcinoma (RCC) with clear cell component that is advanced (not amenable to curative surgery or radiation therapy) or metastatic RCC at the time of registration on study

Participants must have measurable/evaluable disease by RECIST 1.1 criteria. Participants with only bone metastases or only pleural effusions are considered evaluable disease and are eligible

Participants with new or progressive brain metastases (active brain metastases) or leptomeningeal disease must not require immediate central nervous system (CNS) specific treatment at the time of study registration or anticipated treatment during the first cycle of therapy

Participants must not be currently enrolled or plan to participate in treatment studies while enrolled on this study

Participants must not plan to take any over the counter probiotic supplements at time of study registration and while on protocol treatment

NOTE: Vitamin and electrolyte or mineral supplements are permitted

Participants must not have had prior systemic therapy for advanced or metastatic RCC or any treatment with immune based combination therapy

NOTE: Participants can have prior neo/adjuvant treatment with an anti-PD-1, anti-PD-L1, and/or anti-CTLA-4 antibody or other therapies for any current or prior malignancy if \> 12 months prior to registration

Participants must not be receiving steroid replacement therapy for adrenal insufficiency greater than 50 mg daily of hydrocortisone or prednisone equivalent dose at the time of registration

Participants must not require the use of systemic corticosteroids \> 10 mg/day of prednisone or its equivalent for any reason other than replacement therapy for adrenal insufficiency

Participants must not have received any systemic antibiotics within 7 days prior to registration

NOTE: Uncontrolled infections must be completely resolved

Participants must be ≥ 18 years old at the time of registration

Participants must have a Zubrod performance status 0-2 within 28 days of registration

Participants must be able to safely receive at least one of the standard of care regimens, per the current Food and Drug Administration (FDA)-approved package inserts, treating investigator's discretion, and institutional guidelines

NOTE: Participants with favorable risk as defined by the International Metastatic RCC Database Consortium (IMDC) must plan to receive one of the TKI+ immunotherapy treatment combinations. They are not able to receive regimen 1 (ipilimumab + nivolumab) for this study

Participants must be able to swallow and retain oral medications and have no known gastrointestinal disorders likely to interfere with absorption of oral medications

Participants must have serum creatinine ≤ 2 x ULN (upper limit of normal). This specimen must have been drawn and processed within 28 days prior to registration

Hemoglobin ≥ 8 g/dL (within 28 days prior to registration)

Leukocytes ≥ 3 x 10\^3/uL (within 28 days prior to registration)

Absolute neutrophil count ≥ 1.5 x 10\^3/uL (within 28 days prior to registration)

Platelets ≥ 100 x 10\^3/uL (within 28 days prior to registration)

Total bilirubin ≤ institutional upper limit of normal (ULN) unless history of Gilbert's disease (within 28 days prior to registration) Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN

Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 x institutional ULN (\< 5 x institutional ULN if liver metastases are present) (within 28 days prior to registration)

Participants must have alkaline phosphate measured as a part of the liver function assessment within 28 days prior to registration

Participants must have albumin corrected calcium measured within 28 days prior to registration

Participants with a history human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load on the most recent test results obtained within 6 months prior to registration

Participants with a history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to registration

Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to registration

Participants must not have uncontrolled blood pressure and hypertension within 28 days prior to registration

Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen

Participants must not have any known history of an autoimmune disease that prohibits the use of immune checkpoint therapy

Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen

Participants must be offered the opportunity to participate in specimen banking

Participants who have the ability to complete questionnaires in English or Spanish must be offered the opportunity to participate in the patient-reported outcome study

NOTE: As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.

Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines

For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations

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 Springdale?

Yes, this clinical trial (NCT07383441) has an active research site in Springdale, AR 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 Springdale, AR

If you're searching for advanced clear cell renal cell carcinoma treatment options in Springdale, AR, this clinical trial (NCT07383441) 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 Springdale 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 Springdale, AR

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