OncoMatch/Clinical Trials/NCT06399419
CBM588 Capsules in Combination With Nivolumab and Ipilimumab for the Treatment of Advanced Stage Kidney Cancer
Is NCT06399419 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including CBM588 Capsules and Ipilimumab for advanced clear cell renal cell carcinoma.
Treatment: CBM588 Capsules · Ipilimumab · Nivolumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Renal Cell Carcinoma
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: adjuvant or neoadjuvant therapy — completely resectable RCC
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
Cannot have received: ipilimumab (ipilimumab)
Prior treatment with ipilimumab and/or nivolumab
Cannot have received: nivolumab (nivolumab)
Prior treatment with ipilimumab and/or nivolumab
Cannot have received: systemic anticancer therapy
Receipt of any type of cytotoxic, biologic, or other systemic anticancer therapy (including investigational) within 4 weeks before first dose of study treatment
Lab requirements
Blood counts
ANC ≥ 1500/uL without G-CSF support; WBC ≥ 2500/uL; platelets ≥ 100,000/uL without transfusion; hemoglobin ≥ 8 g/dL
Kidney function
Serum calculated creatinine clearance ≥ 50 mL/min using Cockcroft-Gault equation
Liver function
ALT, AST, and ALP ≤ 3 x ULN (ALP ≤ 5 x ULN with documented bone metastases); total bilirubin ≤ 1.5 x ULN (≤ 3 x ULN with Gilbert's disease)
ANC ≥ 1500/uL without granulocyte colony-stimulating factor support; WBC ≥ 2500/uL; platelets ≥ 100,000/uL without transfusion; hemoglobin ≥ 8 g/dL; ALT, AST, and ALP ≤ 3 x ULN (ALP ≤ 5 x ULN with documented bone metastases); total bilirubin ≤ 1.5 x ULN (for subjects with Gilbert's disease ≤ 3 x ULN); serum albumin ≥ 2.8 g/dl; PT/INR or PTT < 1.3 x ULN; serum calculated creatinine clearance ≥ 50 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Medical Center · Duarte, California
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