Actively Recruiting
CBM588 Capsules in Combination With Nivolumab and Ipilimumab for the Treatment of Advanced Stage Kidney Cancer
Led by Osel, Inc. · Updated on 2024-05-30
28
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
Sponsors
O
Osel, Inc.
Lead Sponsor
C
City of Hope Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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. Nivolumab and ipilimumab are monoclonal antibodies that may interfere with the ability of tumor cells to grow and spread by enhancing the ability of the body's immune cells to attack tumor cells. CBM588 in combination with nivolumab and ipilimumab may be safe, tolerable, and/or effective in treating patients with advanced stage kidney cancer.
CONDITIONS
Official Title
CBM588 Capsules in Combination With Nivolumab and Ipilimumab for the Treatment of Advanced Stage Kidney Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and assent if appropriate
- Willingness to allow use of archival tumor tissue or provide approval for exceptions
- ECOG performance status of 0, 1, or 2
- Age 18 years or older
- Histologically confirmed renal cell carcinoma with clear cell or sarcomatoid component
- Advanced or metastatic renal cell carcinoma with intermediate or poor risk by IMDC criteria
- No prior systemic therapy for kidney cancer except one prior adjuvant/neoadjuvant therapy if recurrence occurred after 6 months
- Measurable disease by RECIST 1.1 criteria
- Recovery to grade 1 or less from prior anticancer therapy toxic effects (except alopecia)
- Absolute neutrophil count at least 1500/uL without growth factor support
- White blood cell count at least 2500/uL
- Platelet count at least 100,000/uL without transfusion
- Hemoglobin level at least 8 g/dL
- Liver enzymes ALT, AST, ALP no more than 3 times upper limit normal; ALP up to 5 times ULN if bone metastases
- Total bilirubin no more than 1.5 times ULN (up to 3 times for Gilbert's disease)
- Serum albumin at least 2.8 g/dL
- Coagulation tests PT/INR or PTT less than 1.3 times ULN
- Creatinine clearance at least 50 mL/min by Cockcroft-Gault method
- Agreement to use medically accepted contraception during and after study (specific durations by sex)
- Female subjects of childbearing potential must not be pregnant and meet menopause or sterilization criteria
You will not qualify if you...
- Prior treatment with ipilimumab or nivolumab
- Current use or planned use of probiotics, yogurt, or bacterial fortified foods during treatment
- History of allergic reactions to similar compounds
- Active or treated interstitial lung disease or pneumonitis requiring steroids
- Medical conditions increasing risk or interfering with safety interpretation
- Recent systemic anticancer therapy within 4 weeks before study
- Recent radiation therapy within 2-6 weeks depending on type
- Known brain metastases unless treated and stable for at least 4 weeks
- Administration of live vaccines within 30 days before study
- Uncontrolled illness including recent use of systemic corticosteroids or immunosuppressives
- Active infections including certain viral infections or tuberculosis with active disease
- History of certain lung diseases or active pneumonitis
- Malabsorption syndrome
- Uncompensated hypothyroidism
- Moderate to severe liver impairment
- Need for dialysis
- History of organ or stem cell transplant
- Active known or suspected autoimmune disease except specified exceptions
- Pregnant or breastfeeding females
- Inability or unwillingness to swallow capsules or receive IV treatment
- Known allergy or severe reaction to study drug components
- Active malignancy requiring treatment within past 3 years except certain cured cancers
- History of severe heart or unstable cardiac conditions
- Baseline oxygen saturation below 92% on room air
- Any condition judged unsafe for study participation by investigator
- Inability to comply with study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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