Having a large clinical trial portfolio means giving patients treatment options often not available anywhere else, and years before they become the standard of care. To learn more about Karmanos Cancer Institute clinical trials or to see if a trial is right for you, please call
1-800-KARMANOS (1-800-527-6266)
or request an appointment below
Back to Results
An Open-Label, 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
Cancer Categories
Hematologic (Blood Cancers)
Karmanos Trial ID
2018-094
NCT ID
NCT03671018
Age Group
Adult
Scope
National
Phase
Phase I
Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.
Phase I/II
Principal Investigator
Dipenkumar
Modi, M.D.
Oncology - Hematology, Oncology - Medical
View Profile
Objective:
Phase Ib-Specific Objectives:
Safety Objective:
To evaluate the safety, tolerability, pharmacokinetics, and efficacy of mosunetuzumab in combination with polatuzumab vedotin in patients with B-cell NHL
Phase II-Specific Objectives:
Primary Efficacy Objectives:
To evaluate the efficacy of mosunetuzumab plus polatuzumab vedotin (Arm I) in patients with R/R FL
To evaluate the efficacy of mosunetuzumab plus polatuzumab vedotin (Arm J) compared with polatuzumab vedotin plus bendamustine and rituximab in patients with R/R DLBCL
To evaluate the efficacy of mosunetuzumab plus polatuzumab vedotin (Arm F) compared with polatuzumab vedotin plus bendamustine and rituximab (Arm D)in patients with R/R DLBCL
Secondary Efficacy Objectives:
To evaluate the efficacy of mosunetuzumab plus polatuzumab vedotin (Arm I) in patients with R/R FL
To evaluate the efficacy of mosunetuzumab plus polatuzumab vedotin (Arm J) in patients with R/R DLBCL
To evaluate the efficacy of mosunetuzumab plus polatuzumab vedotin (Arm F) compared with mosunetuzumab alone (Arm E) and compared with polatuzumab vedotin plus bendamustine and rituximab (Arm D) in patients with R/R DLBCL
To evaluate the efficacy of mosunetuzumab plus polatuzumab vedotin (Arm F) compared with mosunetuzumab alone (Arm E) and compared with plus bendamustine followed by obinutuzumab polatuzumab vedotin plus bendamustine and rituximab (Arm D) in patients with R/R DLBCL
Safety Objectives:
To evaluate the safety of mosunetuzumab plus polatuzumab vedotin (Arm I) in patients with R/R FL
To evaluate the safety of mosunetuzumab plus polatuzumab vedotin (Arm J) in patients with R/R DLBCL
To evaluate the safety of mosunetuzumab plus polatuzumab vedotin compared with mosunetuzumab alone and compared with polatuzumab vedotin plus bendamustine and rituximab (Arm D) in patients with R/R DLBCL
Objectives for Both Phase Ib and Phase II:
Pharmacokinetic Objectives:
To characterize the pharmacokinetics of mosunetuzumab as a single agent and when administered in combination with polatuzumab
Immunogenicity Objectives:
To assess the incidence of ADAs to mosunetuzumab
To assess the incidence of ADAs to polatuzumab vedotin
Request an Appointment
Refer a Patient
NCI Dictionary of Cancer Terms
KCI Clinical Trials App
Eligibility
Locations
Applicable Disease Site
Therapies | Drugs | Devices
Eligibility
Eligibility
Inclusion Criteria:
ECOG PS of 0, 1, or 2
Histologically confirmed FL, DLBCL, or MCL
Must have received at least one prior systemic treatment regimen containing an anti-CD20-directed therapy for DLBCL or FL
For MCL, participants must have received at least two prior systemic treatment regiments, which include 1) anti-CD20-directed therapy, 2) BTK inhibitor, and 3) anthracycline or bendamustine
Relapsed to prior regimen(s) after having a documented history of response (complete response [CR], CR unconfirmed [CRu], or partial response [PR]) of >/= 6 months in duration from completion of regimen(s); or, refractory to any prior regimen, defined as no response to the prior therapy, or progression within 6 months of completion of the last dose of therapy
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
Adequate hematologic, renal, and hepatic function
Exclusion Criteria:
Prior treatment with mosunetuzumab or other CD20-directed bispecific antibodies
Prior treatment with polatuzumab vedotin
Current > Grade 1 peripheral neuropathy
Prior use of any monoclonal antibody, radioimmunoconjugate or antibody-drug conjugate (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
Treatment with radiotherapy within 2 weeks prior to the first dose of study treatment
Autologous stem-cell transplantation (SCT) within 100 days prior to first study treatment administration
Prior treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 30 days before first study treatment administration
Prior allogeneic SCT
Prior solid organ transplantation
Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
Patients with history of confirmed progressive multifocal leukoencephalopathy (PML)
Current or past history of central nervous system (CNS) lymphoma or CNS disease
History of autoimmune disease
Locations
Locations
Karmanos Cancer Institute - Detroit Headquarters
4100 John R
Detroit, MI 48201
Get Directions
Phone:
800-527-6266
Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills
31995 Northwestern Hwy
Farmington Hills, MI 48334
Get Directions
Phone:
800-527-6266
Applicable Disease Site
Applicable Disease Site
Non-Hodgkin Lymphoma
Therapies, Drugs, Devices
Therapies | Drugs | Devices
Therapies
Immunotherapy
Drugs
Mosunetuzumab; polatuzumab vedotin
Loading...