Phase II Study of Pumitamig, Bevacizumab, and Pumitamig with Temozolomide in Adults With Recurrent Glioblastoma

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the investigational drug pumitamig alone and in combination with temozolomide, compared to bevacizumab alone, in adults with recurrent glioblastoma GBM, a type of brain cancer. This Phase II study includes participants with a confirmed diagnosis of WHO Grade IV GBM, IDH-wildtype, who have already received standard first-line treatment including radiotherapy and temozolomide. The study aims to understand treatment responses and side effects in this patient group. Participants will be randomly assigned to one of two treatment groups initially pumitamig alone or bevacizumab alone. After reviewing initial safety and effectiveness data from the pumitamig group, a third group receiving pumitamig combined with temozolomide may be added. Treatments are delivered via intravenous infusion for pumitamig and bevacizumab, while temozolomide is taken orally. The treatment phase can last up to two years. Before treatment, there is a screening period of up to 28 days to confirm eligibility. Participants will be monitored for safety for up to 90 days after their last treatment dose or until they start new cancer therapy. After the treatment and safety follow-up, survival status will be tracked until the participant dies, withdraws consent, is lost to follow-up, or the study ends. Researchers will measure tumor response rates, progression-free survival, overall survival, adverse events, and drug levels in the body during the study.

A Clinical Trial Testing the Safety of the Investigational Drug Pumitamig (BNT327) and How Well it Works in Patients With Recurrent Glioblastoma