ERLINDA M GORDON
This is an open label, dose-seeking phase 1/2 study using escalating doses of LURBINECTEDIN administered intravenously with fixed doses of IPILIMUMAB and NIVOLUMAB administered intravenously.
This is an open label, dose-seeking phase 1/2 study using escalating doses of LURBINECTEDIN administered intravenously with fixed doses of IPILIMUMAB and NIVOLUMAB administered intravenously. I. Dose Escalation Phase 1 of Study: The study will employ the standard "cohort of three" design (Storer, 1989). Three participants are treated at each of the 2 ascending dose levels. An additional 3 participants will be enrolled if a DLT is observed in one of the three initially-enrolled participants at each dose level. If no DLT occurs after the third participant in a dose level is on study for 6 weeks…
Inclusion Criteria: Individuals must meet all of the inclusion criteria in order to be eligible to participate in the study, as follows: 1. Male or Female ≥ 18 years of age 2. Pathologically confirmed diagnosis of locally advanced unresectable or metastatic soft tissue sarcoma 3. For the Phase 1 Part of Study, only previously treated participants will be enrolled. For the Phase 2 Part of Study, previously untreated participants will be enrolled. 4. Ability to understand the purposes and risks of the study and has signed and dated a written informed consent form approved by the principal inve…
This is an open label, dose-seeking phase 1/2 study using escalating doses of LURBINECTEDIN administered intravenously with fixed doses of IPILIMUMAB and NIVOLUMAB administered intravenously.
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