Recruiting
Phase 3

MO-03 with SOC

Sponsor:

SWOG Cancer Research Network

Code:

NCT07383441

Conditions

Advanced Clear Cell Renal Cell Carcinoma

Metastatic Clear Cell Renal Cell Carcinoma

Stage III Renal Cell Cancer AJCC v8

Stage IV Renal Cell Cancer AJCC v8

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Axitinib

Biospecimen Collection

Bone Scan

Cabozantinib

Clostridium butyricum CBM 588 Probiotic Strain

Study Details

Brief summary:

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.

Conditions

Advanced Clear Cell Renal Cell Carcinoma

Metastatic Clear Cell Renal Cell Carcinoma

Stage III Renal Cell Cancer AJCC v8

Stage IV Renal Cell Cancer AJCC v8

Study ID

NCT07383441

Start date

Jun 5, 2026

Status verified date

Jun, 2026

Completion date

Jan 31, 2034

Anticipated

Primary completion date

Jan 31, 2033

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

718 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm 1 (MO-03, SOC immunotherapy)

See Detailed Description

placebo comparator: Arm 2 (placebo, SOC immunotherapy)

See Detailed Description

Interventions

Axitinib

Given PO

Biospecimen Collection

Undergo blood sample collection

Bone Scan

Undergo bone scan

Cabozantinib

Given PO

Clostridium butyricum CBM 588 Probiotic Strain

Given PO

Computed Tomography

Undergo CT

Ipilimumab

Given IV

Lenvatinib

Given PO

Magnetic Resonance Imaging

Undergo MRI

Nivolumab

Given IV

Nivolumab and Recombinant Human Hyaluronidase

Given SC

Pembrolizumab

Given IV

Placebo Administration

Given PO

Primary outcome measure

  • Progression-free survival (PFS) [ Time Frame: From date of randomization to date of first documentation of progression, or death due to any cause, assessed up to 5 years ]

Central Contacts and Locations

Locations

Highlands Oncology Group - Fayetteville

Recruiting

Fayetteville, Arkansas, United States, 72703

Contacts

Site Public Contact

479-872-8100research@hogonc.com

Principal Investigator:

Joseph T. Beck

NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

Recruiting

Jonesboro, Arkansas, United States, 72401

Contacts

Site Public Contact

870-936-7066Emily.Carvell@bmhcc.org

Principal Investigator:

Xinyu von Buttlar

Highlands Oncology Group - Rogers

Recruiting

Rogers, Arkansas, United States, 72758

Contacts

Site Public Contact

479-872-8130research@hogonc.com

Principal Investigator:

Joseph T. Beck

Highlands Oncology Group

Recruiting

Springdale, Arkansas, United States, 72762

Contacts

Site Public Contact

479-872-8130research@hogonc.com

Principal Investigator:

Joseph T. Beck

Illinois CancerCare-Bloomington

Recruiting

Bloomington, Illinois, United States, 61704

Contacts

Site Public Contact

309-243-3605andersonj@illinoiscancercare.com

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Canton

Recruiting

Canton, Illinois, United States, 61520

Contacts

Site Public Contact

309-243-3605andersonj@illinoiscancercare.com

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Carthage

Recruiting

Carthage, Illinois, United States, 62321

Contacts

Site Public Contact

309-243-3605andersonj@illinoiscancercare.com

Principal Investigator:

Bryan A. Faller

Cancer Care Specialists of Illinois - Decatur

Recruiting

Decatur, Illinois, United States, 62526

Contacts

Site Public Contact

217-876-4762morganthaler.jodi@mhsil.com

Principal Investigator:

Bryan A. Faller

Decatur Memorial Hospital

Recruiting

Decatur, Illinois, United States, 62526

Contacts

Site Public Contact

217-876-4762morganthaler.jodi@mhsil.com

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Eureka

Recruiting

Eureka, Illinois, United States, 61530

Contacts

Site Public Contact

309-243-3605andersonj@illinoiscancercare.com

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Galesburg

Recruiting

Galesburg, Illinois, United States, 61401

Contacts

Site Public Contact

309-243-3605andersonj@illinoiscancercare.com

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Kewanee Clinic

Recruiting

Kewanee, Illinois, United States, 61443

Contacts

Site Public Contact

309-243-3605andersonj@illinoiscancercare.com

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Macomb

Recruiting

Macomb, Illinois, United States, 61455

Contacts

Site Public Contact

309-243-3605andersonj@illinoiscancercare.com

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Ottawa Clinic

Recruiting

Ottawa, Illinois, United States, 61350

Contacts

Site Public Contact

309-243-3605andersonj@illinoiscancercare.com

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Pekin

Recruiting

Pekin, Illinois, United States, 61554

Contacts

Site Public Contact

309-243-3605andersonj@illinoiscancercare.com

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Peoria

Recruiting

Peoria, Illinois, United States, 61615

Contacts

Site Public Contact

309-243-3605andersonj@illinoiscancercare.com

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Peru

Recruiting

Peru, Illinois, United States, 61354

Contacts

Site Public Contact

309-243-3605andersonj@illinoiscancercare.com

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Princeton

Recruiting

Princeton, Illinois, United States, 61356

Contacts

Site Public Contact

309-243-3605andersonj@illinoiscancercare.com

Principal Investigator:

Bryan A. Faller

Southern Illinois University School of Medicine

Recruiting

Springfield, Illinois, United States, 62702

Contacts

Site Public Contact

217-545-7929

Principal Investigator:

Bryan A. Faller

Illinois CancerCare - Washington

Recruiting

Washington, Illinois, United States, 61571

Contacts

Site Public Contact

309-243-3605andersonj@illinoiscancercare.com

Principal Investigator:

Bryan A. Faller

Mercy Hospital

Recruiting

Cedar Rapids, Iowa, United States, 52403

Contacts

Site Public Contact

319-365-4673

Principal Investigator:

Deborah W. Wilbur

Oncology Associates at Mercy Medical Center

Recruiting

Cedar Rapids, Iowa, United States, 52403

Contacts

Site Public Contact

319-363-2690

Principal Investigator:

Deborah W. Wilbur

Lahey Hospital and Medical Center

Recruiting

Burlington, Massachusetts, United States, 01805

Contacts

Site Public Contact

781-744-3421lhmc-cancer-clinical-trials@lahey.org

Principal Investigator:

Brendan Connell

Lahey Medical Center-Peabody

Recruiting

Peabody, Massachusetts, United States, 01960

Contacts

Site Public Contact

781-744-3421lhmc-cancer-clinical-trials@lahey.org

Principal Investigator:

Brendan Connell

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Recruiting

Brighton, Michigan, United States, 48114

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Tareq Al baghdadi

Trinity Health IHA Medical Group Hematology Oncology - Canton

Recruiting

Canton, Michigan, United States, 48188

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Tareq Al baghdadi

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Recruiting

Chelsea, Michigan, United States, 48118

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Tareq Al baghdadi

Trinity Health Saint Mary Mercy Livonia Hospital

Recruiting

Livonia, Michigan, United States, 48154

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Tareq Al baghdadi

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Recruiting

Ypsilanti, Michigan, United States, 48197

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Tareq Al baghdadi

Baptist Memorial Hospital and Cancer Center-Golden Triangle

Recruiting

Columbus, Mississippi, United States, 39705

Contacts

Site Public Contact

901-226-1366BCCclintrials@bmhcc.org

Principal Investigator:

Xinyu von Buttlar

Baptist Cancer Center-Grenada

Recruiting

Grenada, Mississippi, United States, 38901

Contacts

Site Public Contact

901-226-1366BCCclintrials@bmhcc.org

Principal Investigator:

Xinyu von Buttlar

Baptist Memorial Hospital and Cancer Center-Union County

Recruiting

New Albany, Mississippi, United States, 38652

Contacts

Site Public Contact

901-226-1366BCCclintrials@bmhcc.org

Principal Investigator:

Xinyu von Buttlar

Baptist Memorial Hospital and Cancer Center-Oxford

Recruiting

Oxford, Mississippi, United States, 38655

Contacts

Site Public Contact

901-226-1366BCCclintrials@bmhcc.org

Principal Investigator:

Xinyu von Buttlar

Baptist Memorial Hospital and Cancer Center-Desoto

Recruiting

Southhaven, Mississippi, United States, 38671

Contacts

Site Public Contact

901-226-1366BCCclintrials@bmhcc.org

Principal Investigator:

Xinyu von Buttlar

Saint Francis Medical Center

Recruiting

Cape Girardeau, Missouri, United States, 63703

Contacts

Site Public Contact

573-334-2230sfmc@sfmc.net

Principal Investigator:

Bryan A. Faller

Parkland Health Center - Farmington

Recruiting

Farmington, Missouri, United States, 63640

Contacts

Site Public Contact

314-996-5569

Principal Investigator:

Bryan A. Faller

Sainte Genevieve County Memorial Hospital

Recruiting

Sainte Genevieve, Missouri, United States, 63670

Contacts

Site Public Contact

314-996-5569

Principal Investigator:

Bryan A. Faller

Missouri Baptist Medical Center

Recruiting

St Louis, Missouri, United States, 63131

Contacts

Site Public Contact

314-996-5569

Principal Investigator:

Bryan A. Faller

Missouri Baptist Sullivan Hospital

Recruiting

Sullivan, Missouri, United States, 63080

Contacts

Site Public Contact

314-996-5569

Principal Investigator:

Bryan A. Faller

Baptist Memorial Hospital and Cancer Center-Collierville

Recruiting

Collierville, Tennessee, United States, 38017

Contacts

Site Public Contact

901-226-1366BCCclintrials@bmhcc.org

Principal Investigator:

Xinyu von Buttlar

Baptist Memorial Hospital and Cancer Center-Memphis

Recruiting

Memphis, Tennessee, United States, 38120

Contacts

Site Public Contact

901-226-1366BCCclintrials@bmhcc.org

Principal Investigator:

Xinyu von Buttlar

More Information

Sponsor

SWOG Cancer Research Network

Last update posted

Jun 11, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by SWOG Cancer Research Network on 2026-06-11.