OncoMatch/Clinical Trials/NCT04028063
Doxorubicin Plus Dual Checkpoint Blockade for Soft Tissue Sarcomas
Is NCT04028063 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Balstilimab and Zalifrelimab for metastatic soft tissue sarcoma.
Treatment: Balstilimab · Zalifrelimab · Doxorubicin · Botensilimab — This is an open-label, non-randomized, single-institution, single arm Phase II study conducted using a Simon two-stage design with an additional safety lead-in. The overall objective is to determine the efficacy of combination doxorubicin with dual checkpoint blockade with anti-CTLA-4 antibody AGEN1884 and anti-PD-1 antibody AGEN2034. The investigators will estimate the progression-free survival rate at 6 months (PFS6mo) of doxorubicin plus AGEN1884/AGEN2034 in comparison to historical PFS6mo with doxorubicin monotherapy, calculated as the mean from two large randomized Phase 3 clinical trials.
Check if I qualifyExtracted eligibility criteria
Cancer type
Sarcoma
Disease stage
Grade: high grade (for undifferentiated pleomorphic sarcomas)
advanced or metastatic soft tissue sarcoma (STS) (by local pathology review), not curable by surgery
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anthracycline
NO prior anthracyclines
Cannot have received: checkpoint inhibitor
NO prior checkpoint inhibitors
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥1,000 /mcL; Platelets ≥100,000 / mcL; Hemoglobin ≥8 g/dL without EPO dependency.
Kidney function
Serum creatinine ≤1.5 X ULN OR measured/calculated creatinine clearance ≥60 mL/min for subjects with creatinine levels > 1.5 X institutional ULN. GFR can also be used in place of creatinine or CrCl.
Liver function
Serum total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN. Exception: Subjects with known history of Gilbert's disease should be ≤ 1.5 X of the patient's prior baseline. AST (SGOT) and ALT (SGPT) ≤2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases. Albumin >2.5 mg/dL.
Cardiac function
Ejection Fraction ≥50% by 2D ECHO at Screening. Prolonged QTc interval on Screening EKG ≤475 ms.
Adequate organ function as defined in protocol. [...] Ejection Fraction <50% by 2D ECHO at Screening [excluded]. Prolonged QTc interval on Screening EKG >475 ms [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Colorado Hospital · Aurora, Colorado
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