OncoMatch/Clinical Trials/NCT06937866
Maintenance Zanzalintinib With Etoposide After HDCT in GCT
Is NCT06937866 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Zanzalintinib and Etoposide Capsule for germ cell tumor.
Treatment: Zanzalintinib · Etoposide Capsule — This is an open label, single arm phase I/II trial of maintenance zanzalintinib in combination with oral etoposide in patients with relapsed GCT treated with HDCT and PBSCT with a safety lead-in cohort in patients with relapsed, refractory metastatic GCT.
Check if I qualifyExtracted eligibility criteria
Cancer type
Testicular Germ Cell Tumor
Disease stage
Required: Stage IV
Metastatic disease required
incurable, refractory or relapsed metastatic germ cell tumor
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: cisplatin-based combination chemotherapy (cisplatin) — initial
Must have received initial cisplatin-based combination chemotherapy AND demonstrated progression following at least one salvage regimen for advanced germ-cell neoplasm and now considered incurable with standard therapies, including further chemotherapy or surgery.
Must have received: salvage chemotherapy — advanced
demonstrated progression following at least one salvage regimen for advanced germ-cell neoplasm
Must have received: high-dose chemotherapy and peripheral blood stem cell transplant — salvage
Completed salvage treatment with HDCT and PBSCT for 2 tandem cycles per Institutional Guidelines
Cannot have received: zanzalintinib (zanzalintinib)
Prior treatment with zanzalintinib
Cannot have received: etoposide (if prior hypersensitivity not recovered with supportive care) (etoposide)
Exception: if prior hypersensitivity not recovered with supportive care
Prior hypersensitivity to etoposide which did not recover with supportive care
Lab requirements
Blood counts
Hemoglobin ≥ 9g/dL; WBC ≥ 2500/µL; Absolute neutrophil count ≥ 1500/mm3; Platelet count ≥ 100,000/mm3
Kidney function
Calculated creatinine clearance ≥ 50 mL/min (≥ 0.67 mL/sec) using the Cockcroft Gault equation; Urine protein-to-creatinine ratio (UPCR) ≤ 1 mg/mg (≤ 113.2 mg/mmol) creatinine.
Liver function
Total bilirubin ≤ 1.5 X ULN except patients with documented Gilbert's syndrome (≤ 3 X ULN); ALT, AST, ALP ≤3 X ULN; for patients with hepatic metastases, ALT and AST ≤ 5 X ULN. For subjects with documented bone metastasis ALP ≤ 5 X ULN.
Cardiac function
Corrected QT interval calculated by the Fridericia formula (QTcF) ≤ 480 ms per electrocardiogram (ECG) within 14 days of study registration.
Adequate laboratory values obtained within 14 days prior to registration for protocol therapy and as defined below: ... Hemoglobin ≥ 9g/dL ... WBC ≥ 2500/µL ... Absolute neutrophil count ≥ 1500/mm3 ... Platelet count ≥ 100,000/mm3 ... Total bilirubin ≤ 1.5 X ULN except patients with documented Gilbert's syndrome (≤ 3 X ULN) ... ALT, AST, ALP ≤3 X ULN; for patients with hepatic metastases, ALT and AST ≤ 5 X ULN. For subjects with documented bone metastasis ALP ≤ 5 X ULN. ... Calculated creatinine clearance ≥ 50 mL/min (≥ 0.67 mL/sec) using the Cockcroft Gault equation. ... Urine protein-to-creatinine ratio (UPCR) ≤ 1 mg/mg (≤ 113.2 mg/mmol) creatinine. ... Corrected QT interval calculated by the Fridericia formula (QTcF) ≤ 480 ms per electrocardiogram (ECG) within 14 days of study registration.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center · Indianapolis, Indiana
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