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Gut bacteria boosts immunotherapy in kidney cancer fight?

NCT ID NCT07383441

Disease control Sponsor: SWOG Cancer Research Network Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tests whether adding a live biotherapy called MO-03 to standard immunotherapy can help control advanced or metastatic clear cell renal cell carcinoma. MO-03 is designed to improve gut health, which may make immunotherapy work better. About 718 participants will receive either MO-03 or a placebo alongside their regular treatment. The study aims to see if this combination delays cancer progression.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 718 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Jan 2034

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

clear cell renal carcinoma Clear-cell metastatic renal cell carcinoma renal cell adenocarcinoma renal cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    41 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Baptist Cancer Center-Grenada

    RECRUITING

    Grenada, Mississippi, 38901, United States

    Contact Email: •••••@•••••

  • Baptist Memorial Hospital and Cancer Center-Collierville

    RECRUITING

    Collierville, Tennessee, 38017, United States

    Contact Email: •••••@•••••

  • Baptist Memorial Hospital and Cancer Center-Desoto

    RECRUITING

    Southhaven, Mississippi, 38671, United States

    Contact Email: •••••@•••••

  • Baptist Memorial Hospital and Cancer Center-Golden Triangle

    RECRUITING

    Columbus, Mississippi, 39705, United States

    Contact Email: •••••@•••••

  • Baptist Memorial Hospital and Cancer Center-Memphis

    RECRUITING

    Memphis, Tennessee, 38120, United States

    Contact Email: •••••@•••••

  • Baptist Memorial Hospital and Cancer Center-Oxford

    RECRUITING

    Oxford, Mississippi, 38655, United States

    Contact Email: •••••@•••••

  • Baptist Memorial Hospital and Cancer Center-Union County

    RECRUITING

    New Albany, Mississippi, 38652, United States

    Contact Email: •••••@•••••

  • Cancer Care Specialists of Illinois - Decatur

    RECRUITING

    Decatur, Illinois, 62526, United States

  • Decatur Memorial Hospital

    RECRUITING

    Decatur, Illinois, 62526, United States

  • Highlands Oncology Group

    RECRUITING

    Springdale, Arkansas, 72762, United States

    Contact Email: •••••@•••••

  • Highlands Oncology Group - Fayetteville

    RECRUITING

    Fayetteville, Arkansas, 72703, United States

    Contact Email: •••••@•••••

  • Highlands Oncology Group - Rogers

    RECRUITING

    Rogers, Arkansas, 72758, United States

    Contact Email: •••••@•••••

  • Illinois CancerCare - Washington

    RECRUITING

    Washington, Illinois, 61571, United States

  • Illinois CancerCare-Bloomington

    RECRUITING

    Bloomington, Illinois, 61704, United States

  • Illinois CancerCare-Canton

    RECRUITING

    Canton, Illinois, 61520, United States

  • Illinois CancerCare-Carthage

    RECRUITING

    Carthage, Illinois, 62321, United States

  • Illinois CancerCare-Eureka

    RECRUITING

    Eureka, Illinois, 61530, United States

  • Illinois CancerCare-Galesburg

    RECRUITING

    Galesburg, Illinois, 61401, United States

  • Illinois CancerCare-Kewanee Clinic

    RECRUITING

    Kewanee, Illinois, 61443, United States

  • Illinois CancerCare-Macomb

    RECRUITING

    Macomb, Illinois, 61455, United States

  • Illinois CancerCare-Ottawa Clinic

    RECRUITING

    Ottawa, Illinois, 61350, United States

  • Illinois CancerCare-Pekin

    RECRUITING

    Pekin, Illinois, 61554, United States

  • Illinois CancerCare-Peoria

    RECRUITING

    Peoria, Illinois, 61615, United States

  • Illinois CancerCare-Peru

    RECRUITING

    Peru, Illinois, 61354, United States

  • Illinois CancerCare-Princeton

    RECRUITING

    Princeton, Illinois, 61356, United States

  • Lahey Hospital and Medical Center

    RECRUITING

    Burlington, Massachusetts, 01805, United States

  • Lahey Medical Center-Peabody

    RECRUITING

    Peabody, Massachusetts, 01960, United States

  • Mercy Hospital

    RECRUITING

    Cedar Rapids, Iowa, 52403, United States

  • Missouri Baptist Medical Center

    RECRUITING

    St Louis, Missouri, 63131, United States

  • Missouri Baptist Sullivan Hospital

    RECRUITING

    Sullivan, Missouri, 63080, United States

  • NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

    RECRUITING

    Jonesboro, Arkansas, 72401, United States

  • Oncology Associates at Mercy Medical Center

    RECRUITING

    Cedar Rapids, Iowa, 52403, United States

  • Parkland Health Center - Farmington

    RECRUITING

    Farmington, Missouri, 63640, United States

  • Saint Francis Medical Center

    RECRUITING

    Cape Girardeau, Missouri, 63703, United States

  • Sainte Genevieve County Memorial Hospital

    RECRUITING

    Sainte Genevieve, Missouri, 63670, United States

  • Southern Illinois University School of Medicine

    RECRUITING

    Springfield, Illinois, 62702, United States

  • Trinity Health IHA Medical Group Hematology Oncology - Brighton

    RECRUITING

    Brighton, Michigan, 48114, United States

  • Trinity Health IHA Medical Group Hematology Oncology - Canton

    RECRUITING

    Canton, Michigan, 48188, United States

  • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

    RECRUITING

    Chelsea, Michigan, 48118, United States

  • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

    RECRUITING

    Ypsilanti, Michigan, 48197, United States

  • Trinity Health Saint Mary Mercy Livonia Hospital

    RECRUITING

    Livonia, Michigan, 48154, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.