OncoMatch/Clinical Trials/NCT06968988
Zanzalintinib in Combination With Ipilimumab and Nivolumab in Patients With Metastatic Soft Tissue Sarcoma
Is NCT06968988 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Zanzalintinib and Ipilimumab for metastatic soft-tissue sarcoma.
Treatment: Zanzalintinib · Ipilimumab · Nivolumab — The investigators hypothesize that zanzalintinib in combination with ipilimumab and nivolumab will be well tolerated and serve as a potential therapeutic strategy in metastatic soft tissue sarcoma (mSTS) including myxofibrosarcoma, undifferentiated pleomorphic sarcoma, dedifferentiated liposarcoma, cutaneous angiosarcoma, and undifferentiated sarcoma histologies.
Check if I qualifyExtracted eligibility criteria
Cancer type
Sarcoma
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: any systemic therapy — metastatic
Must have received at least one but no more than 3 lines of therapy in the metastatic setting, with progression on last line of therapy.
Cannot have received: zanzalintinib (zanzalintinib)
Prior treatment with zanzalintinib
Cannot have received: cabozantinib (cabozantinib)
Prior treatment with cabozantinib
Cannot have received: PD-1 inhibitor (cemiplimab, nivolumab, pembrolizumab)
Prior treatment with PD-1 inhibitor (eg, cemiplimab, nivolumab, pembrolizumab)
Cannot have received: PD-L1 inhibitor (atezolizumab, avelumab, durvalumab)
Prior treatment with PD-L1 inhibitor (eg, atezolizumab, avelumab, durvalumab)
Cannot have received: CTLA-4 inhibitor (ipilimumab)
Prior treatment with CTLA-4 inhibitor (eg, ipilimumab)
Cannot have received: small molecule kinase inhibitor
Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment.
Cannot have received: cytotoxic, biologic, or other 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.
Cannot have received: radiation therapy for bone metastasis
Radiation therapy for bone metastasis within 2 weeks before first dose of study treatment
Cannot have received: other radiation therapy
any other radiation therapy within 4 weeks before first dose of study treatment
Cannot have received: systemic treatment with radionuclides
Systemic treatment with radionuclides within 6 weeks before first dose of study treatment
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 1.5 K/cumm without granulocyte colony-stimulating factor support within 2 weeks prior to screening laboratory collection; Platelets ≥ 100 K/cumm without transfusion within 2 weeks prior to screening laboratory collection; Hemoglobin ≥ 9.0 g/dL without transfusion within 2 weeks prior to screening laboratory collection
Kidney function
Calculated creatinine clearance ≥ 40 mL/min by Cockcroft-Gault; UPCR ≤ 1 mg/mg (≤ 113.2 mg/mmol) creatinine
Liver function
Total bilirubin ≤ 1.5 x IULN (for subjects with Gilbert's disease ≤ 3 x IULN); AST(SGOT), ALT(SGPT), and alkaline phosphatase (ALP) ≤ 3.0 x IULN. For subjects with documented bone metastasis, ALP ≤ 5.0 x IULN; Serum albumin ≥ 2.8 g/dL; Moderate to severe hepatic impairment (Child-Pugh B or C) excluded
Cardiac function
INR ≤ 1.5 and aPTT ≤ 1.2 x IULN. For subjects on Factor Xa inhibitors, criteria does not apply; Corrected QT interval calculated by the Fridericia formula (QTcF) ≤ 480 ms within 14 days per ECG before first dose of study treatment; Unstable or deteriorating cardiovascular disorders excluded (see comorbidities)
Adequate bone marrow and organ function as defined below: [see details above]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Washington University School of Medicine · St Louis, Missouri
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