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New treatment option for Clear Cell Renal Cell Carcinoma
Official title Adding a Live Biotherapeutic Product (CBM588) to Pembrolizumab for the Treatment of Renal Cell Cancer After Surgery
ClinicalTrials.gov ID: NCT07037004
What this study is testing
What is Clostridium butyricum CBM588 Strain?
Clostridium butyricum CBM588 Strain is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for clear cell renal cell carcinoma.
Also referred to as C. butyricum CBM588 Strain, C. butyricum MIYAIRI Strain.
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 II trial compares the effect of adding a Live Biotherapeutic Product called CBM588 to pembrolizumab versus pembrolizumab alone in preventing return of disease (recurrence) after surgery for patients with renal cell cancer. Pembrolizumab is an immune checkpoint inhibitor.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 12 months
- Which group you join is decided by chance.
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
- Be willing and able to provide informed consent for the trial
- Histological confirmation of renal cell carcinoma (RCC) with a clear-cell or sarcomatoid component
- Pathologic stage of pT2, G4 or sarcomatoid, N0M0; pT3, any grade, N0M0; pT4, any grade, N0M0; pTany, any grade, N+M0; or M1 no evidence of disease...
- No prior systemic immunotherapy for RCC
- Eastern Cooperative Oncology Group (ECOG) performance status \< 2
You likely can't join if
- Prior radiation or anti-PD1, anti-PDL1, or anti-CTLA-4 therapy for RCC
- Any active or recent history of a known or suspected autoimmune disease or recent history of a syndrome that required systemic corticosteroids (\> 10...
- Active interstitial lung disease (ILD)/pneumonitis or history of ILD/pneumonitis requiring treatment with systemic steroids
- Baseline pulse oximetry less than 92% "on room air"
- Current use, or intent to use probiotics, prebiotics, yogurt, bacterial fortified foods and other natural supplements ≤ 2 weeks prior to treatment...
- Any condition requiring systemic treatment with corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within...
See the full eligibility criteria
- Be willing and able to provide informed consent for the trial
- Histological confirmation of renal cell carcinoma (RCC) with a clear-cell or sarcomatoid component
- Pathologic stage of pT2, G4 or sarcomatoid, N0M0; pT3, any grade, N0M0; pT4, any grade, N0M0; pTany, any grade, N+M0; or M1 no evidence of disease (NED) after resection
- No prior systemic immunotherapy for RCC
- Eastern Cooperative Oncology Group (ECOG) performance status \< 2
- Males and females, ages ≥ 18
- Any ethnicity or race
- Calculated creatinine clearance ≥ 30 milliliters per minute (mL/min) per the Cockcroft and Gault formula or serum creatinine \< 1.5 x upper limit of normal (ULN)
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \< 3 x ULN (\< 5 x ULN if liver metastases are present)
- Total bilirubin \< 1.5 x ULN (except people with Gilbert syndrome, who can have total bilirubin up to 3.0 mg/dL)
- Adequate bone marrow function defined by any of the following laboratory test findings: white blood cells (WBC) \> 2,000/mm\^3, neutrophils \> 1,500/mm\^3, platelets \> 100,000/mm\^3
- Female people of child-bearing potential and female partners of male people must agree to use a highly effective method of contraception during treatment and for at least 5 months after the last dose
- Highly effective methods of contraception include: tubal ligation, an approved hormonal contraceptive such as oral contraceptives, patches, implants, injections, rings or hormonally impregnated intrauterine device...
- Prior radiation or anti-PD1, anti-PDL1, or anti-CTLA-4 therapy for RCC
- Any active or recent history of a known or suspected autoimmune disease or recent history of a syndrome that required systemic corticosteroids (\> 10 mg daily prednisone equivalent) or immunosuppressive medications...
- Active interstitial lung disease (ILD)/pneumonitis or history of ILD/pneumonitis requiring treatment with systemic steroids
- Baseline pulse oximetry less than 92% "on room air"
- Current use, or intent to use probiotics, prebiotics, yogurt, bacterial fortified foods and other natural supplements ≤ 2 weeks prior to treatment initiation and during the period of treatment
- Any condition requiring systemic treatment with corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to first dose of study drug. Inhaled steroids and...
- Uncontrolled adrenal insufficiency
- 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...
- Not recovered to ≤ grade 1 toxicities related to any prior therapy before administration of study drug
- Women who are pregnant or breastfeeding
- 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 arrhythmia, uncontrolled...
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Irvine, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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; Irvine, 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.