Open label, randomized, controlled phase II study preceded by a safety run-in part in subjects with advanced or metastatic soft-tissue sarcoma.~Safety Run-in Part: Six (6) patients will be treated with 1000 mg/m2 dacarbazine (DTIC) on Day 1 every 3 weeks plus 13 µg/kg L19TNF on Days 1, 3 and 5 every 3 weeks to test for safety of the combination. Should unacceptable toxicities occur in ≥ 2 patients during an observation period from Day 1 to Day 21 (first cycle), enrollment will be stopped at this dose level and 6 patients will be treated sequentially with DTIC at 850 mg/m2 on Day 1 every 3 weeks plus 13 µg/kg L19TNF on Days 1, 3 and 5 every 3 weeks.~Tumor Activity Evaluation Part~Approximately 86 patients will be enrolled and parallel assigned in a 1:1 fashion to one of two different arms, as follows:~Arm 1: Patients will receive DTIC on Day 1 every 3 weeks plus L19TNF on Days 1, 3 and 5 every 3 weeks.~Arm 2: Patients will receive DTIC on Day 1 every 3 weeks. During the conduct of the study, detailed safety parameters will be routinely reviewed by the DSMB.
Open label, randomized, controlled phase II study preceded by a safety run-in part in subjects with advanced or metastatic soft-tissue sarcoma.