An Open Label, Randomized, Multicenter, Phase Ib/II Trial Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination with Polatuzumab Vedotin in patients with B-Cell Non-Hodgkin Lymphoma(GO40516)(PSCI18-058)
This is a drug study that will compare drug mosunetuzumab with drug polatuzumab vedotin in patients with non-Hodgkin lymphoma (NHL).
This study has three parts: 1. Screening (to see if you are eligible for the study) 2. Treatment 3. Follow-up (to check on you after treatment is finished) If you are enrolled in the FL or DLBCL cohort during the single-arm expansion phase, you will receive mosunetuzumab for 8-17 cycles and polatuzumab vedotin for 6 cycles, with each cycle lasting 21 days. In addition to the single-arm expansion phase, the study may open another expansion phase of the study for the DLBCL cohort. If you are enrolled in the additional DLBCL expansion phase, you will be randomly assigned to one of three possible arms. Neither you nor your study doctor may choose the arm you will be in. - Mosunetuzumab in combination with polatuzumab vedotin - Mosunetuzumab alone - Bendamustine plus rituximab in combination with polatuzumab vedotin After your last dose, your study doctor will follow up with you about every 3 months for approximately 2 years or longer (as long as you agree to it). Your total time in the study (Phase II expansion portion) will depend on how your DLBCL, FL, or MCL responds to treatment. This could range from 1 day to more than 2 1/2 years.
Life expectancy of at least 12 weeks
Measurable disease, defined as at least one bi-dimensionally measurable nodal lesion, defined as > 1.5 cm in its longest dimension, or at least one bi-dimensionally measurable extranodal lesion, defined as > 1.0 cm in its longest dimension
Adverse events from prior anti-cancer therapy resolved to < or = Grade 1
Hepatic Function: < or =AST and ALT < or = 2.5 x ULN; total bilirubin < or = 1.5 x ULN
Prior treatment with mosunetuzumab or other CD20-directed bispecific antibodies
Prior treatment with polatuzumab vedotin
Prior use of any monoclonal antibody, radioimmunoconjugate or ADC within 4 weeks before first dose of study treatment
Treatment with any chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to first dose of study treatment