Glofitamab With Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma
brief summary
This phase II trial tests the safety and effectiveness of glofitamab given in combination with pirtobrutinib in treating patients with mantle cell lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Glofitamab and obinutuzumab are monoclonal antibodies that may interfere with the ability of cancer cells to grow and spread. Obinutuzumab may also reduce the risk of immune-related conditions from treatment. Pirtobrutinib is in a class of medications called kinase inhibitors. It works by blocking the action of the protein that signals cancer cells to multiply. Giving glofitamab in combination with pirtobrutinib may be safe, tolerable and/or effective in treating patients with relapsed or refractory mantle cell lymphoma.
detailed description
PRIMARY OBJECTIVES:
I. To characterize the safety and tolerability of the combination of glofitamab and pirtobrutinib in the first six participants enrolled.
II. To evaluate the preliminary efficacy of glofitamab and pirtobrutinib in participants with relapsed or refractory mantle cell lymphoma (MCL) as measured by complete response rate.
SECONDARY OBJECTIVES:
I. To evaluate the preliminary efficacy of glofitamab and pirtobrutinib in participants with relapsed or refractory MCL as measured by progression-free survival and overall survival.
II. To characterize the magnitude and duration of anti-tumor activity by objective response rate and duration of response.
III. To characterize the safety and tolerability of the combination of glofitamab and pirtobrutinib.
IV. To evaluate the preliminary efficacy of glofitamab and pirtobrutinib in participants with relapsed or refractory MCL as measured by complete response without measurable disease (CRMRD-) rate.
V. To evaluate the time-to-complete response without measurable residual disease (CRMRD-).
VI. To evaluate the treatment-free interval among participants who discontinue treatment following CRMRD- status.
EXPLORATORY OBJECTIVES:
I. To explore associations between baseline tumor characteristics including genetic (e.g. mutations in BTK) and immune profiles (e.g. expression of co-inhibitory receptors and T cell phenotypes) and outcomes in participants administered the combination of glofitamab and pirtobrutinib.
II. To explore the effects of the combination of glofitamab and pirtobrutinib on pharmacodynamic markers relating to drug mechanism (e.g. emergence of clones with mutations conferring resistance to the study combination).
III. To estimate the quality of life of participants during therapy with glofitamab and pirtobrutinib.
IV. To explore time-to-CRMRD- during therapy with glofitamab and pirtobrutinib.
official title
A Multicenter Phase 2 Study of Glofitamab With Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma