Regorafenib With Temozolomide With or Without RT in MGMT-Methylated, IDH Wild-type GBM Patients
Status:
Recruiting
Trial end date:
2025-12-01
Target enrollment:
Participant gender:
Summary
This study will evaluate the addition of regorafenib to standard of care treatment with TMZ
as adjuvant therapy, and in combination with TMZ+RT as concomitant therapy.
The standard of care for newly diagnosed GBM (ndGBM) includes surgical resection to the
extent that is safely feasible, followed by RT plus concomitant TMZ chemotherapy, and up to 6
months of adjuvant TMZ.
The dose escalation will be explored following a "3+3" design, escalating oral doses of
regorafenib in combination with adjuvant (maintenance) TMZ (cohort A) to estimate the MTD of
regorafenib as adjuvant (maintenance) therapy. After finding the MTD in the Adjuvant Therapy
dose escalation, the Concomitant Therapy (cohort B) dose escalation will start, exploring
escalating oral doses of regorafenib in combination with concomitant TMZ+RT, to estimate the
MTD of regorafenib as concomitant therapy.