OncoMatch/Clinical Trials/NCT04650984
A Study Comparing the Efficacy of L19TNF+Doxorubicin vs Doxorubicin Alone as First-line Therapy in Patients With Advanced or Metastatic Soft Tissue Sarcoma
Is NCT04650984 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Onfekafusp alfa and Doxorubicin for soft tissue sarcoma.
Treatment: Onfekafusp alfa · Doxorubicin — The present study is an open-label, randomized, controlled, two-arm multi-center study of the efficacy of L19TNF treatment in combination with doxorubicin versus doxorubicin alone in advanced or metastatic soft-tissue sarcoma patients. In the study, 102 patients will be randomized in a 1:1 ratio to receive doxorubicin treatment (Arm 1) or L19TNF treatment in combination with doxorubicin (Arm 2). The primary objective of the trial is to evaluate if L19TNF in combination with doxorubicin (Arm 2) given for unresectable or metastatic soft tissue sarcoma improves efficacy measured as progression free survival, as compared to doxorubicin alone (Arm 1).
Check if I qualifyExtracted eligibility criteria
Cancer type
Sarcoma
Disease stage
Grade: 23 (fnclcc)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: systemic therapy
Exception: surgery and radiation allowed
Prior therapy (except surgery and radiation) for unresectable or metastatic malignant soft tissue sarcoma
Cannot have received: anthracycline-containing chemotherapy
Previous treatment with anthracycline-containing chemotherapy
Cannot have received: recombinant TNF
Previous therapy with recombinant TNF
Lab requirements
Blood counts
ANC ≥ 1.5 x 10^9/L, platelets ≥ 100 x 10^9/L, haemoglobin (Hb) ≥ 9.0 g/dl
Kidney function
chronically impaired renal function or creatinine ≥ 2.0 x ULN [excluded]
Liver function
ALT, AST, ALP or total bilirubin < 2.5 x ULN
Cardiac function
No history within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris. Heart insufficiency (> Grade II, NYHA criteria). Clinically significant cardiac arrhythmias or requiring permanent medication. Uncontrolled hypertension, despite optimal therapy. Ischemic peripheral vascular disease (Grade IIb-IV according to Leriche-Fontaine classification).
Absolute neutrophil count (ANC) < 1.5 x 10^9/L, platelets < 100 x 10^9/L and haemoglobin (Hb) < 9.0 g/dl. Chronically impaired renal function or creatinine ≥ 2.0 x ULN. Inadequate liver function (ALT, AST, ALP or total bilirubin ≥ 2.5 x ULN). History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris. Heart insufficiency (> Grade II, New York Heart Association (NYHA) criteria). Clinically significant cardiac arrhythmias or requiring permanent medication. Uncontrolled hypertension, despite optimal therapy. Ischemic peripheral vascular disease (Grade IIb-IV according to Leriche-Fontaine classification).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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