OncoMatch/Clinical Trials/NCT05188118
Rapid Sequencing of Approved Therapies in Patients with Metastatic or Unresectable Clear Cell Renal Cell Carcinoma
Is NCT05188118 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies multiple treatments for renal cell carcinoma.
Treatment: Cabozantinib · Ipilimumab · Nivolumab · Lenvatinib · Everolimus — This is a pilot, single-center, single-arm study where 20 patients with metastatic or unresectable clear cell renal cell carcinoma will receive same sequential treatment strategy (Cabozantinib for 12 weeks, then proceed with Ipilimumab plus Nivolumab immunotherapy x4 over 12 weeks, then subsequent therapies depending on treatment response for another 12 weeks \[Nivolumab for CR/PR/SD, Cabozantinib or Lenvatinib/Everolimus for PROG\]).
Check if I qualifyExtracted eligibility criteria
Cancer type
Renal Cell Carcinoma
Disease stage
Required: Stage IV
Performance status
ECOG OR KPS 0–1
Prior therapy
Cannot have received: cabozantinib (cabozantinib)
Prior treatment with cabozantinib
Cannot have received: nivolumab (nivolumab)
Prior treatment with nivolumab
Cannot have received: ipilimumab (ipilimumab)
Prior treatment with ipilimumab
Cannot have received: systemic kidney cancer directed therapy for advanced disease
Exception: adjuvant treatment post definitive local therapy is acceptable
any other systemic kidney cancer directed therapy for advanced disease (i.e. must be treatment naïve for advanced disease; adjuvant treatment post definitive local therapy is acceptable)
Lab requirements
Blood counts
Hgb ≥ 9.0g/dL; White blood count ≥ 2500/ µL; ANC ≥1 x 10^9/L (≥1500/L) without growth factor support; Plt count ≥ 100 x 10^9 /L (≥100,000/L) without transfusion; PT/INR or PTT test ≥ 1.3 x the laboratory ULN
Kidney function
Serum creatinine ≤ 2.0 x ULN or calculated creatinine clearance ≥ 30 mL/min; UPCR ≤ 1mg/mg (≤113.2 mg/mmol) or 24-h urine protein ≤ 1 g
Liver function
Total serum bilirubin ≤1.5 x institutional ULN; Gilbert's disease, Total serum bilirubin ≤3 x institutional ULN; Serum transaminases (AST/ALT) ≤3 x the institutional ULN; ALP ≤5 x the institutional ULN with documented bone metastasis; Serum albumin ≥ 2.8 g/dl
Cardiac function
QTcF ≤ 500 ms per ECG within 14 days before first dose of study treatment
Adequate normal organ, marrow and coagulation function based on below labs within 14 days before first dose of study treatment
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Icahn School of Medicine at Mount Sinai · New York, New York
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