Clostridium butyricum CBM 588 Probiotic Strain

DRUG4 trials

Sponsors

City of Hope Medical Center, SWOG Cancer Research Network

Conditions

Advanced Clear Cell Renal Cell CarcinomaAdvanced Papillary Renal Cell CarcinomaAdvanced Renal Cell CarcinomaAdvanced Sarcomatoid Renal Cell CarcinomaClear Cell Renal Cell CarcinomaHematopoietic and Lymphoid Cell NeoplasmMetastatic Clear Cell Renal Cell CarcinomaMetastatic Papillary Renal Cell Carcinoma

Phase 1

CBM588, Nivolumab, and Ipilimumab in Treating Patients With Stage IV or Advanced Kidney Cancer

CompletedNCT03829111

City of Hope Medical CenterAdvanced Renal Cell Carcinoma, Clear Cell Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma +3

Start: 2019-05-14End: 2023-12-13Updated: 2024-07-03

CBM588 in Improving Clinical Outcomes in Patients Who Have Undergone Donor Hematopoietic Stem Cell Transplant

Active, not recruitingNCT03922035

City of Hope Medical CenterHematopoietic and Lymphoid Cell Neoplasm

Start: 2019-04-18End: 2027-02-05Updated: 2026-04-07

CBM588 in Combination With Nivolumab and Cabozantinib for the Treatment of Advanced or Metastatic Kidney Cancer

Active, not recruitingNCT05122546

City of Hope Medical CenterAdvanced Clear Cell Renal Cell Carcinoma, Advanced Papillary Renal Cell Carcinoma, Advanced Renal Cell Carcinoma +9

Start: 2021-11-01End: 2027-01-12Updated: 2026-03-05

Phase 3

Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer

RecruitingNCT07383441

SWOG Cancer Research NetworkAdvanced Clear Cell Renal Cell Carcinoma, Metastatic Clear Cell Renal Cell Carcinoma, Stage III Renal Cell Cancer AJCC v8 +1

Start: 2026-06-05End: 2034-01-31Target: 718Updated: 2026-06-11

Related Papers

Microbial dysbiosis as predictor of benefit from CBM588 as an adjunct to immune checkpoint blockade (ICB)–based first line therapies in metastatic renal cell carcinoma (mRCC).

Journal of Clinical Oncology2026-05-27

Poor nutritional intake prior to allogeneic hematopoietic cell transplantation is associated with higher incidence of lower-gastrointestinal graft-versus-host disease

Blood2025-11-03

Microbiome and cytokine features are associated with graft-versus-host disease incidence in allogeneic hematopoietic cell transplantation patients

Blood2025-11-03

Long-term clinical outcomes with nivolumab/ipilimumab with or without <i>Clostridium butyricum</i> MIYAIRI588 in metastatic renal cell carcinoma (mRCC): A randomized phase Ib clinical trial.

Journal of Clinical Oncology2025-05-281 citations

Cabozantinib (cabo) and nivolumab (nivo) with or without CBM588 in patients with metastatic renal cell carcinoma: Updated clinical outcomes of a phase I study.

Journal of Clinical Oncology2025-02-101 citations

Cabozantinib and nivolumab with or without live bacterial supplementation in metastatic renal cell carcinoma: a randomized phase 1 trial

Nature Medicine2024-06-2863 citations

Randomized Placebo-Controlled, Biomarker-Stratified Phase Ib Microbiome Modulation in Melanoma: Impact of Antibiotic Preconditioning on Microbiome and Immunity

Cancer Discovery2024-04-0353 citations

Evolution of the functionality of microbial communities in patients with metastatic renal cell carcinoma (mRCC) receiving cabozantinib (cabo)/nivolumab (nivo) with or without CBM588: A randomized clinical trial.

Journal of Clinical Oncology2024-01-29

Effect of CBM588 in combination with cabozantinib plus nivolumab for patients (pts) with metastatic renal cell carcinoma (mRCC): A randomized clinical trial.

Journal of Clinical Oncology2023-06-0720 citations

Assessment of short-chain fatty acid (SCFA) and circulating cytokine trends in a clinical trial of nivolumab/ipilimumab and CBM588 in metastatic renal cell carcinoma (mRCC).

Journal of Clinical Oncology2023-06-011 citations

Prevalence of dietary modification and supplement use in patients with metastatic renal cell carcinoma (mRCC).

Journal of Clinical Oncology2023-02-20

A phase I trial to evaluate the biologic effect of CBM588 (<i>Clostridium butyricum</i>) in combination with cabozantinib plus nivolumab for patients with metastatic renal cell carcinoma (mRCC).

Journal of Clinical Oncology2022-06-012 citations

Characterization of the microbial resistome in a prospective trial of CBM588 in metastatic renal cell carcinoma (mRCC) offers mechanism for interplay between antibiotic (abx) use and immune checkpoint inhibitor (ICI) activity.

Journal of Clinical Oncology2022-06-011 citations

Nivolumab plus ipilimumab with or without live bacterial supplementation in metastatic renal cell carcinoma: a randomized phase 1 trial

Nature Medicine2022-02-28426 citations

Nivolumab/ipilimumab with or without CBM588 in metastatic renal cell carcinoma: A randomized phase Ib study and the evolution of the functionality of microbial communities with treatment.

Journal of Clinical Oncology2022-02-16

Intestinal microbiome associated with development of grade 3/4 adverse in patients with metastatic renal cell carcinoma (mRCC) treated with nivolumab plus ipilimumab (N/I) and probiotic support: Results from a phase Ib study.

Journal of Clinical Oncology2022-02-16

A Randomized Open Label Pilot Study of <i>Clostridium Butyricum</i> Miyairi 588 (CBM588) in Recipients of Allogeneic Hematopoietic Cell Transplantation

Blood2021-11-052 citations

First results of a randomized phase IB study comparing nivolumab/ipilimumab with or without CBM-588 in patients with metastatic renal cell carcinoma.

Journal of Clinical Oncology2021-05-2015 citations

Randomized trial assessing impact of probiotic supplementation on gut microbiome and clinical outcome from targeted therapy in metastatic renal cell carcinoma

Cancer Medicine2020-11-0173 citations

A phase I trial to assess the biologic effect of CBM588 (<i>Clostridium butyricum</i>) in combination with nivolumab plus ipilimumab (nivo/ipi) in patients with metastatic renal cell carcinoma (mRCC).

Journal of Clinical Oncology2020-02-194 citations