Clinical Studies Search

Protocol Summary


Protocol No.
PSCI-18-058
Prinicipal Investigator
Naik, Seema
Phase
Phase I/II
Age Group
Adult
Scope
National
Secondary Protocol No.
GO40516
Title
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
Objective
Phase Ib:
To evaluate the safety and tolerability of mosunetuzumab plus polatuzumab vedotin in patients with R/R DLBCL or FL, including estimation of the MTD, determination of the RP2D, and characterization of DLTs
Efficacy Objective
To make a preliminary assessment of the anti-tumor activity of mosunetuzumab plus polatuzumab vedotin

Phase II:
To evaluate the efficacy of mosunetuzumab plus polatuzumab vedotin compared with polatuzumab vedotin plus bendamustine and rituximab in patients with R/R DLBCL
To evaluate the efficacy of mosunetuzumab plus polatuzumab vedotin compared with physician?s choice of rituximab plus chemotherapy (CHOP or CVP) or obinutuzumab plus bendamustine followed by obinutuzumab maintenance in patients with R/R FL
To evaluate the efficacy of mosunetuzumab plus polatuzumab vedotin compared with mosunetuzumab alone in patients with R/R DLBCL and R/R FL
To evaluate the efficacy of mosunetuzumab plus polatuzumab vedotin compared with mosunetuzumab alone and compared with polatuzumab vedotin plus bendamustine and rituximab in patients with R/R DLBCL
To evaluate the efficacy of mosunetuzumab plus polatuzumab vedotin compared with mosunetuzumab alone and compared with physician?s choice of rituximab plus chemotherapy (CHOP or CVP) or obinutuzumab plus bendamustine followed by obinutuzumab maintenance in patients with R/R FL
To evaluate the efficacy of mosunetuzumab plus polatuzumab vedotin compared with mosunetuzumab alone and compared with polatuzumab vedotin plus bendamustine and rituximab in patients with R/R DLBCL

To assess the pharmacokinetics of rituximab in combination with bendamustine and polatuzumab vedotin or chemotherapy (CHOP or CVP) compared with historical data
To assess the pharmacokinetics of polatuzumab vedotin in combination with bendamustine and rituximab compared with historical data
To assess the pharmacokinetics of obinutuzumab in combination with bendamustine followed by obinutuzumab maintenance compared with historical data

To evaluate the safety of mosunetuzumab plus polatuzumab vedotin compared with mosunetuzumab alone and compared with polatuzumab vedotin plus bendamustine and rituximab in patients with R/R DLBCL
To evaluate the safety of mosunetuzumab plus polatuzumab vedotin compared with mosunetuzumab alone and compared with physician?s choice of rituximab plus chemotherapy (CHOP or CVP) or obinutuzumab plus bendamustine followed by obinutuzumab maintenance in patients with R/R FL

Phase Ib and II:
To characterize the pharmacokinetics of mosunetuzumab as a single agent and when administered in combination with polatuzumab
Exploratory Pharmacokinetic Objectives
To characterize the pharmacokinetics of polatuzumab vedotin when administered in combination with mosunetuzumab
To characterize the relationship between pharmacokinetics and safety, biomarkers, or efficacy
To assess potential PK interactions between mosunetuzumab and polatuzumab vedotin

To assess the incidence of ADAs to mosunetuzumab and polatuzumab vedotin

To identify biomarkers that are predictive of response to mosunetuzumab plus polatuzumab vedotin (i.e., predictive biomarkers), are associated with progression to a more severe disease state (i.e., prognostic biomarkers), are associated with acquired resistance to mosunetuzumab plus polatuzumab vedotin, are associated with susceptibility to developing adverse events, can provide evidence of mosunetuzumab plus polatuzumab vedotin activity, or can increase the knowledge and understanding of disease biology
To make a preliminary assessment of response to mosunetuzumab plus polatuzumab vedotin in different clinical and biologic prognostic subgroups of NHL
To make a preliminary assessment of MRD status following mosunetuzumab treatment as a single agent and in combination with polatuzumab vedotin

To assess health status of patients
Applicable Disease Sites
Other
Status
Open
Participating Institutions
Hershey Medical Center