OncoMatch/Clinical Trials/NCT06439836
Pembrolizumab Plus CA-4948 for the Treatment of Patients With Progressive Metastatic Urothelial Cancer Despite Prior Immunotherapy
Is NCT06439836 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Emavusertib and Pembrolizumab for metastatic urothelial carcinoma.
Treatment: Emavusertib · Pembrolizumab — This phase I trial tests the safety, side effects, best dose, and effectiveness of emavusertib (CA-4948) in combination with pembrolizumab in treating patients with urothelial cancer that has spread from where it first started to other places in the body (metastatic) and that has a resistance to PD-1/PD-L1 immune checkpoint inhibitors. CA-4948, a kinase inhibitor, may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving CA-4948 in combination with pembrolizumab may be safe, tolerable and/or effective in treating patients with metastatic urothelial cancer that is resistant to PD-1/PD-L1 immune checkpoint inhibitors.
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: anti-PD-1 therapy
Must have received prior treatment with a PD-1 or PD-L1 inhibitor
Must have received: platinum-based chemotherapy
Must have received at least one of the following (may have been administered concurrently or sequentially with PD-1/PD-L1 inhibitor): Platinum-based chemotherapy
Must have received: antibody-drug conjugate (enfortumab vedotin)
Must have received at least one of the following (may have been administered concurrently or sequentially with PD-1/PD-L1 inhibitor): Enfortumab vedotin
Lab requirements
Blood counts
Leukocytes ≥ 3,000/mcL; ANC ≥ 1,500/mcL; Platelets ≥ 100,000/mcL; Hemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L (without pRBC transfusion within prior 2 weeks; stable erythropoietin allowed)
Kidney function
Creatinine < 1.5 × institutional ULN or creatinine clearance of ≥ 30 mL/min for patients with creatinine ≥ 1.5 x institutional ULN
Liver function
Total bilirubin ≤ 1.5 x institutional ULN; AST ≤ 3 x ULN; ALT ≤ 3 x ULN
Leukocytes ≥ 3,000/mcL; ANC ≥ 1,500/mcL; Platelets ≥ 100,000/mcL; Hemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L; CPK < grade 2 (≤ 2.5 ULN); Creatinine < 1.5 × ULN or CrCl ≥ 30 mL/min; Total bilirubin ≤ 1.5 x ULN; AST ≤ 3 x ULN; ALT ≤ 3 x ULN; INR or PT ≤ 1.5 x ULN unless on anticoagulant; aPTT ≤ 1.5 x ULN unless on anticoagulant
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Comprehensive Cancer Center · Duarte, California
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care · Irvine, California
- UC San Diego Moores Cancer Center · La Jolla, California
- UC Irvine Health/Chao Family Comprehensive Cancer Center · Orange, California
- University of Miami Miller School of Medicine-Sylvester Cancer Center · Miami, Florida
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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