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OncoMatch/Clinical Trials/NCT05559879

Cabozantinib and Dostarlimab in Recurrent Gynecologic Carcinosarcoma

Is NCT05559879 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Cabo + Dostarlimab for gynecologic cancer.

Phase 1/2RecruitingUniversity of Alabama at BirminghamNCT05559879Data as of May 2026

Treatment: Cabo + DostarlimabImmunotherapy has gained a significant amount of attention recently, but its efficacy as a single agent in gynecological cancers has been disappointing. Pre-clinical evidence supports the combination of using Vascular Endothelial Growth Factors (VEGF) inhibitors with immunotherapy. VEGF inhibitors suppress the activation of tumor-associated macrophages (TAMs) and VEGF has been shown to affect the functional maturation of dendritic cells; therefore, VEGF inhibitors could improve the function of antigen presentation. In this study, Cabozantinib (VEGF inhibitor) and Dostarlimab (immunotherapeutic drug) will be admnistered as a combination to patients with recurrent gynecologic carcinosarcoma.

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Extracted eligibility criteria

Cancer type

Endometrial Cancer

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 1 prior line

Must have received: cytotoxic chemotherapy

Received at least one prior chemotherapy regimen for their cancer

Cannot have received: cabozantinib (cabozantinib)

Prior treatment with cabozantinib

Cannot have received: small molecule kinase inhibitor

Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks or 5 half-lives (whichever is longer) 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

Exception: bone metastasis within 2 weeks, any other radiation therapy within 4 weeks, systemic radionuclides within 6 weeks before first dose

Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before the first dose of study treatment.

Lab requirements

Blood counts

ANC ≥ 1500/mm3 without G-CSF; WBC ≥ 2500/mm3; platelets ≥ 100,000/mm3 without transfusion; hemoglobin ≥ 9 g/dL

Kidney function

serum creatinine ≤ 2.0 x ULN or calculated creatinine clearance ≥ 30 mL/min (Cockcroft-Gault); urine protein/creatinine ratio (UPCR) ≤ 1 mg/mg (≤ 113.2 mg/mmol)

Liver function

ALT, AST, ALP ≤ 3 x ULN (ALP ≤ 5 x ULN with documented bone metastases); total bilirubin ≤ 1.5 x ULN (≤ 3 x ULN for Gilbert's disease); serum albumin ≥ 2.8 g/dl

Cardiac function

QTcF ≤ 500 ms per ECG within 28 days before first dose

Adequate organ and marrow function, based upon meeting all of the following laboratory criteria within 14 days before first dose of study treatment: ... (see full criteria above); Corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms per electrocardiogram (ECG) within 28 days before first dose of study treatment

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • O'Neal Comprehensive Cancer Center at UAB · Birmingham, Alabama

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