Balstilimab Treatment for Relapsed or Refractory Classical Hodgkin and Primary Mediastinal B-cell Lymphomas A Phase 2 Safety and Effectiveness Study

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the drug balstilimab in adults with relapsed or refractory lymphomas, specifically classical Hodgkin lymphoma or primary mediastinal B-cell lymphoma. This open-label phase 2 study focuses on patients who have no available standard therapy or have not responded to previous treatments. The study aims to gather important information about this treatment option under the guidance of the Immune Oncology Research Institute. Participants will receive balstilimab at a dose of 300 mg given intravenously every three weeks using an infusion pump. The treatment period can last up to 24 months or until certain criteria require stopping the drug or withdrawal from the study. The study includes a screening period of about 28 days before treatment and a follow-up period of up to 24 months after the last dose for those still living. During the study, participants will have regular assessments to monitor their response to treatment and safety. Researchers will measure outcomes like the objective response rate, duration of response, disease control, progression-free survival, and overall survival for up to 48 months. Safety will be closely monitored through tracking adverse events and laboratory tests. The total time a participant may be involved in the study can be approximately 49 months across all study periods.

Assessment of the Safety and Efficacy of Balstilimab for the Treatment of Relapsed/Refractory Lymphomas (IMMONC0001)