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New treatment option for Advanced Clear Cell Renal Cell Carcinoma
Official title CBM588 Capsules in Combination With Nivolumab and Ipilimumab for the Treatment of Advanced Stage Kidney Cancer
ClinicalTrials.gov ID: NCT06399419
What this study is testing
What is CBM588 Capsules?
CBM588 Capsules is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for advanced clear cell renal cell carcinoma.
Also referred to as CBM588, Clostridium butyricum MIYAIRI 588.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase I trial tests the safety, side effects, best dose, and effectiveness of CBM588 in combination with nivolumab and ipilimumab in treating patients with kidney cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). CBM588 is a live biotherapeutic that may help improve the effects of immunotherapy.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Documented informed consent of the participant and/or legally authorized representative
- Assent, when appropriate, will be obtained per institutional guidelines
- Agreement to allow the use of archival tissue from diagnostic tumor biopsies
- If unavailable, exceptions may be granted with study principle investigator (PI) approval
- Eastern Cooperative Oncology Group (ECOG) ≤ 2
You likely can't join if
- Prior treatment with ipilimumab and/or nivolumab
- Current use, or intent to use, probiotics, yogurt, or bacterial fortified foods during the period of treatment
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent
- Active interstitial lung disease (ILD)/pneumonitis or history of ILD/pneumonitis requiring treatment with systemic steroids
- Known medical condition (e.g., a condition associated with diarrhea or acute diverticulitis) that, in the investigator's opinion, would increase the...
- Receipt of any type of cytotoxic, biologic, or other systemic anticancer therapy (including investigational) within 4 weeks before first dose of...
See the full eligibility criteria
Who can join
- Documented informed consent of the participant and/or legally authorized representative
- Assent, when appropriate, will be obtained per institutional guidelines
- Agreement to allow the use of archival tissue from diagnostic tumor biopsies
- If unavailable, exceptions may be granted with study principle investigator (PI) approval
- Eastern Cooperative Oncology Group (ECOG) ≤ 2
- Age ≥ 18 years
- Histologically confirmed renal cell carcinoma with clear cell renal cell carcinoma component or sarcomatoid component
- Advanced (not amenable to curative surgery or radiation therapy) or metastatic (American Joint Committee on Cancer [AJCC] stage IV) renal cell carcinoma with intermediate- or poor-risk disease by International...
- No prior systemic therapy for renal cell carcinoma (RCC) with the following exception:
- One prior adjuvant or neoadjuvant therapy for completely resectable RCC if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy
- Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- Fully recovered from the acute toxic effects (except alopecia) to ≤ grade 1 to prior anti-cancer therapy
- Absolute neutrophil count (ANC) ≥ 1500/uL without granulocyte colony-stimulating factor support
- White blood cell count ≥ 2500/uL
- Platelets ≥ 100,000/uL without transfusion
- Hemoglobin ≥ 8 g/dL
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) ≤ 3 x upper limit of normal (ULN). ALP ≤ 5 x ULN with documented bone metastases
- Total bilirubin ≤ 1.5 x ULN (for people with Gilbert's disease ≤ 3 x ULN)
- Serum albumin ≥ 2.8 g/dl
- Prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test \< 1.3 x the laboratory ULN
- Serum calculated creatinine clearance ≥ 50mL/min using the Cockcroft-Gault equation
- Sexually active fertile people and their partners must agree to use medically accepted methods of contraception (e.g., barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the...
- Female people of childbearing potential must not be pregnant at screening. Female people are considered to be of childbearing potential unless one of the following criteria is met: documented permanent sterilization...
- Note: Documentation may include review of medical records, medical examinations, or medical history interview by study site
What rules you out
- Prior treatment with ipilimumab and/or nivolumab
- Current use, or intent to use, probiotics, yogurt, or bacterial fortified foods during the period of treatment
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent
- Active interstitial lung disease (ILD)/pneumonitis or history of ILD/pneumonitis requiring treatment with systemic steroids
- Known medical condition (e.g., a condition associated with diarrhea or acute diverticulitis) that, in the investigator's opinion, would increase the risk associated with study participation or study drug administration...
- Receipt of any type of cytotoxic, biologic, or other systemic anticancer therapy (including investigational) within 4 weeks before first dose of study treatment
- Radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before first dose of study...
- Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks prior to first dose of study treatment after...
- Administration of a live, attenuated vaccine within 30 days before first dose of study treatment
- The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:
- Any condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days before first dose of study treatment. Note: Inhaled...
- Active infection requiring systemic treatment. Acute or chronic hepatitis B or C infection, known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness requiring systemic...
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
- Malabsorption syndrome
- Uncompensated/symptomatic hypothyroidism
- Moderate to severe hepatic impairment (Child-Pugh B or C)
- Requirement for hemodialysis or peritoneal dialysis
- History of solid organ or allogenic stem cell transplant
- Other clinically significant disorders that would preclude safe study participation
- Any active, known, or suspected autoimmune disease will be excluded, with the following exceptions:
- Type 1 diabetes mellitus
- Hypothyroidism only requiring hormone replacement
- Skin disorders (e.g., vitiligo, psoriasis, or alopecia) not requiring systemic treatment
- Conditions not expected to recur in the absence of an external trigger
- Pregnant or lactating females
- Inability to swallow tablets/capsules or unwillingness or inability to receive IV administration
- Previously identified allergy or hypersensitivity to components of the study treatment formulations or history of severe infusion-related reactions to monoclonal antibodies. people with rare hereditary problems of...
- Any other active malignancy at time of first dose of study treatment or diagnosis of another malignancy within 3 years prior to first dose of study treatment that requires active treatment, except for locally curable...
- Exclusion of people with a history of myocarditis or congestive heart failure (as defined by New York Heart Association Functional Classification III or IV), as well as unstable angina, serious uncontrolled cardiac...
- Exclusion of people whose baseline pulse oximetry is less than 92% on room air
- Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
- Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.