Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Follicular

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

B-cell Lymphoma

Lymphosarcoma

Follicular Lymphoma

All Drugs and Chemicals

Antibodies

Antibodies, Bispecific

Immunoglobulins

Polatuzumab vedotin

Immunoconjugates

Immunologic Factors

Patients receive CD3xCD20 bispecific antibody mosunetuzumab administered subcutaneously in combination with CD79b directed ADC polatuzumab vedotin administered intravenously. Mosunetuzumab and polatuzumab vedotin are given in combination for 6 cycles. Mosunetuzumab is given on Days 1, 8, and 15 of cycle 1 and then Day 1 thereafter, and polatuzumab vedotin is given on Day 1. After 6 cycles, patients continue on mosunetuzumab alone for 2 additional cycles. Patients undergo scans at the end of cycle 8, and if those scans show a complete response, patients will stop any further treatment and will enter follow-up. Patients with a partial response or stable disease on scans at the end of cycle 8 may receive up to 9 additional cycles of mosunetuzumab in the absence of disease progression or unacceptable toxicity. All cycles are planned to be 21 days.

Mosunetuzumab is administered subcutaneously using a "step-up" dosing strategy. The initial dose on C1D1 will be 5 mg, and doses thereafter will be 45 mg.

Mosunetuzumab

Polatuzumab vedotin is administered intravenously over 90 minutes for the initial dose, and over 30 minutes thereafter.

David A Russler-Germain, M.D., Ph.D.

Brad Kahl, M.D.

Neha Mehta-Shah, M.D.

Nancy L Bartlett, M.D.

Fei Wan, Ph.D.

Todd Fehniger, M.D., Ph.D.

This phase II clinical trial studies the combination of mosunetuzumab and polatuzumab vedotin in order to see how well it works in patients with untreated follicular lymphoma. Mosunetuzumab is an antibody that has been engineered to attach to two target cells in the immune system: T cells that normally perform tasks like killing virus-infected cells, and cancerous B cells. Mosunetuzumab has been designed to direct these T cells to kill the cancerous B cells instead. Polatuzumab vedotin is an antibody-drug conjugate that attaches to certain cancerous B cells and then delivers a drug specifically to those cells.

Mosunetuzumab and Polatuzumab Vedotin for Untreated Follicular Lymphoma

A Phase II Study Evaluating the Efficacy of Mosunetuzumab in Combination With Polatuzumab Vedotin in Untreated Follicular Lymphoma

CR determined by response to treatment by PET-CT at end of treatment per Deauville 5-point scale (Lugano 2014 criteria). The Deauville scale is scored from 1 to 5, with 1 indicating no uptake on PET-CT and 5 indicating markedly increased uptake on PET-CT.

CR determined by response to treatment by PET-CT after Cycle 8 per Deauville 5-point scale (Lugano 2014 criteria). The Deauville scale is scored from 1 to 5, with 1 indicating no uptake on PET-CT and 5 indicating markedly increased uptake on PET-CT.

PR determined by response to treatment by PET-CT after Cycle 8 per Deauville 5-point scale (Lugano 2014 criteria). The Deauville scale is scored from 1 to 5, with 1 indicating no uptake on PET-CT and 5 indicating markedly increased uptake on PET-CT.

CR and PR determined by response to treatment by PET-CT after Cycle 8 per Deauville 5-point scale (Lugano 2014 criteria). The Deauville scale is scored from 1 to 5, with 1 indicating no uptake on PET-CT and 5 indicating markedly increased uptake on PET-CT.

SD determined by response to treatment by PET-CT after Cycle 8 per Deauville 5-point scale (Lugano 2014 criteria). The Deauville scale is scored from 1 to 5, with 1 indicating no uptake on PET-CT and 5 indicating markedly increased uptake on PET-CT.

PD determined by response to treatment by PET-CT after Cycle 8 per Deauville 5-point scale (Lugano 2014 criteria). The Deauville scale is scored from 1 to 5, with 1 indicating no uptake on PET-CT and 5 indicating markedly increased uptake on PET-CT.

CR determined by response to treatment by PET-CT after Cycle 2 per Deauville 5-point scale (Lugano 2014 criteria). The Deauville scale is scored from 1 to 5, with 1 indicating no uptake on PET-CT and 5 indicating markedly increased uptake on PET-CT.

PR determined by response to treatment by PET-CT after Cycle 2 per Deauville 5-point scale (Lugano 2014 criteria). The Deauville scale is scored from 1 to 5, with 1 indicating no uptake on PET-CT and 5 indicating markedly increased uptake on PET-CT.

CR and PR determined by response to treatment by PET-CT after Cycle 2 per Deauville 5-point scale (Lugano 2014 criteria). The Deauville scale is scored from 1 to 5, with 1 indicating no uptake on PET-CT and 5 indicating markedly increased uptake on PET-CT.

SD determined by response to treatment by PET-CT after Cycle 2 per Deauville 5-point scale (Lugano 2014 criteria). The Deauville scale is scored from 1 to 5, with 1 indicating no uptake on PET-CT and 5 indicating markedly increased uptake on PET-CT.

PD determined by response to treatment by PET-CT after Cycle 2 per Deauville 5-point scale (Lugano 2014 criteria). The Deauville scale is scored from 1 to 5, with 1 indicating no uptake on PET-CT and 5 indicating markedly increased uptake on PET-CT.

Progression-free survival is defined from the time from study enrollment to the first occurrence of disease progression as determined by the investigator with use of the Lugano Response Criteria or death from any cause.

Overall survival is defined from the time from study enrollment to death from any cause.

Response determined by PET-CT per the Deauville 5-point scale (Lugano 2014 criteria). The Deauville scale is scored from 1 to 5, with 1 indicating no uptake on PET-CT and 5 indicating markedly increased uptake on PET-CT. Response assessment is performed after cycle 2 (estimated to be day 42), after cycle 8 (estimated to be at 6 months), and at end of treatment (estimated to be 1 year).

Response determined by PET-CT per the Deauville 5-point scale (Lugano 2014 criteria). The Deauville scale is scored from 1 to 5, with 1 indicating no uptake on PET-CT and 5 indicating markedly increased uptake on PET-CT. Response assessment is performed after cycle 2 (estimated to be day 42), after cycle 8 (estimated to be at 6 months), and at end of treatment (estimated to be 1 year)

Time to next treatment (TTNT) initiation is defined as the time from study enrollment to the first documented administration of a new anti-lymphoma treatment (including chemotherapy, radiotherapy, radioimmunotherapy, or immunotherapy) after completion of study treatment.

TEAEs are defined as adverse events that are possibly, probably, or definitely related to study treatment and occur on or after first dose of study treatment..

Tocilizumab is recommended for treatment of grade 2 CRS and required for grade 3 or 4 CRS. Tocilizumab should be administered by IV infusion for a maximum of 4 doses.

Spots Global Cancer Trial Database for Mosunetuzumab and Polatuzumab Vedotin for Untreated Follicular Lymphoma

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