OncoMatch/Clinical Trials/NCT04874311
Bintrafusp Alfa and Doxorubicin Hydrochloride in Treating Patients With Advanced Sarcoma
Is NCT04874311 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Bintrafusp alfa and Doxorubicin for advanced soft-tissue sarcoma.
Treatment: Bintrafusp alfa · Doxorubicin — This study encompasses two multicenter, prospective, open-labeled, 2-arm, non-comparative randomized phase II trials to assess the antitumor activity of bintrafusp alfa in association with doxorubicin
Check if I qualifyExtracted eligibility criteria
Cancer type
Sarcoma
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anthracycline (doxorubicin, daunorubicin, epirubicin, idarubicin, anthracediones)
Previous treatment with doxorubicin, daunorubicin, epirubicin, idarubicin and/or any other anthracyclines or anthracediones at the maximum cumulative dose
Cannot have received: PD-1/PD-L1/transforming growth factor beta 1 (TGFB1) targeted therapy
any approved or investigational treatment targeting PD1, PD-L1 or TGFB1
Cannot have received: mediastinal radiation
Prior mediastinal radiation
Lab requirements
Blood counts
Adequate hematological function
Kidney function
Adequate renal function
Liver function
Adequate hepatic function
Cardiac function
Mean resting corrected QT interval (QTcF) < 470 msec, no clinically important ECG abnormalities, LVEF > 50%, no factors increasing risk of QTc prolongation or arrhythmic events, no recent major cardiac events or procedures
Adequate hematological, renal, metabolic and hepatic function; cardiac criteria: Mean resting corrected QT interval (QTcF) ≥ 470 msec, obtained from three consecutive ECGs, any clinically important abnormalities in rhythm, conduction or morphology of resting ECG, LVEF ≤ 50% per CTCAE v5 by MUGA or echocardiogram, any factors increasing the risk of QTc prolongation or arrhythmic events such as heart failure, hypokalaemia, potential for torsades de pointes, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years old or any concomitant medication known to prolong the QT interval, experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, unstable angina pectoris, uncontrolled hypertension, congestive heart failure NYHA Grade ≥2, ventricular arrhythmias requiring continuous therapy, supraventricular arrhythmias including atrial fibrillation, which are uncontrolled, haemorrhagic or thrombotic stroke, including transient ischaemic attacks, cerebral vascular accident/stroke or any other central nervous system bleeding
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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