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    Phase III: Glofitamab in Large B-Cell Lymphoma (SKYGLO)

    Clinical Trial Overview Inclusion and Exclusion Criteria Study Site Locations Enrollment and Resources
    Clinical Trial Overview

    Clinical Trial Overview

    Active, not recruiting

    A Phase III, Multicenter, Randomized, Open-Label Study Comparing the Efficacy and Safety of Glofitamab (RO7082859) in Combination With Polatuzumab Vedotin Plus Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (Pola-R-CHP) Versus Pola-R-CHP in Previously Untreated Patients With Large B-Cell Lymphoma

    Objective

    The purpose of this study is to compare the efficacy and safety of glofitamab in combination with polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP) vs Pola-R-CHP in participants with previously untreated CD20-positive large B-cell lymphoma (LBCL).

    Trial Design

    Pola-R-CHP= polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone; LBCL= large B-cell lymphoma.

    Primary Endpoints

    • Progression-free survival (PFS) as determined by Independent Review Facility (IRF)

    Secondary Endpoints

    • PFS as determined by the investigator
    • PFS as determined by the investigator and IRF for participants with international prognostic index (IPI) 3-5
    • Event-free survival efficacy causes (EFSeff)
    • Complete response (CR) rate
    • Objective response rate (ORR)
    • Overall survival (OS)
    • Duration of response (DOR)
    • Duration of complete response (DOCR)
    • Disease-free survival (DFS)
    • Serum concentration of glofitamab
    • Incidence of anti-drug antibodies (ADAs)
    • Proportion of participants experiencing a clinically meaningful improvement in physical functioning and fatigue (EORTC QLQ-C30) and lymphoma symptoms (FACT-Lym LymS)
    • Time to deterioration in physical functioning and fatigue (EORTC QLQ-C30) and lymphoma symptoms (FACT-Lym LymS)
    • Percentage of Participants with Adverse Events (AEs)

    Glofitamab

    Other names: Not Applicable

    Modality: CD20xCD3 T-cell engaging bispecific antibody

    Disease/Condition: Large B-Cell Lymphoma

    View Molecule

    ADDITIONAL RESOURCES

    Contact an MSL
    Submit Medical Inquiry
    View Related Clinical Trials

    ID: NCT06047080

    View on ClinicalTrials.gov
    Inclusion and Exclusion Criteria

    Inclusion and Exclusion Criteria

    Inclusion Criteria
    • Previously untreated participants with CD20-positive LBCL
    • Ability to provide tumor tissue
    • International prognostic index (IPI) score 2-5
    • Eastern cooperative oncology group (ECOG) performance status of 0, 1, or 2
    • At least one bi-dimensionally measurable lesion, defined as > 1.5 cm in its longest dimension as measured by CT or MRI
    • Left ventricular ejection fraction (LVEF) >/=50% on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO)
    • Adequate hematologic function
    • Negative HIV test at screening with exceptions as defined by the protocol
    • Negative SARS-CoV-2 antigen or PCR test
    Exclusion Criteria
    • Contraindication to any of the individual components of Pola-R-CHP or glofitamab, including prior receipt of anthracyclines, or history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies, or known sensitivity or allergy to murine products
    • Prior solid organ transplantation
    • Participants receiving systemic immunosuppressive agent such as, but not limited to cyclosporin, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents within 4 weeks prior to first dose of study treatment
    • Current Grade > 1 peripheral neuropathy by clinical examination or demyelinating form of Charcot-Marie-Tooth disease
    • History of indolent lymphoma (e.g., Follicular Lymphoma, Marginal Zone Lymphoma, Waldenstrom macroglobulinemia)
    • Current diagnosis of the following: Follicular lymphoma grade 3B; transformations of indolent B-cell lymphomas (e.g., de novo transformed follicular lymphoma); mediastinal grey zone lymphoma; primary mediastinal (thymic) large B-cell lymphoma; Burkitt lymphoma; primary large B-cell lymphoma of immune-privileged sites (encompassing primary diffuse large B-cell lymphoma of the CNS, primary large B-cell lymphoma of the vitreoretina and primary large B-cell lymphoma of the testis); primary effusion DLBCL; and primary cutaneous DLBCL, leg type
    • Primary or secondary CNS lymphoma at the time of recruitment or history of CNS lymphoma
    • Prior treatment with systemic immunotherapeutic agents
    • Prior use of any monoclonal antibody for the purposes of treating cancer within 3 months of the start of Cycle 1
    • Any investigational therapy for the purposes of treating cancer within 28 days prior to the start of Cycle 1
    • Prior radiotherapy to the mediastinal/pericardial region
    • Prior therapy for LBCL, with the exception of corticosteriods
    • Corticosteroid use > 30 mg/day of prednisone or equivalent, for purposes other than lymphoma symptom control
    • History of other malignant or non-malignant diseases that could affect compliance with the protocol or interpretation of results
    • Significant or extensive history of cardiovascular disease
    • Recent major surgery (within 4 weeks prior to the start of Cycle 1), other than for diagnosis
    • Current or past history of central nervous system (CNS) disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
    • Known or suspected chronic active Epstein-Barr viral infection
    • Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
    • Active autoimmune disease requiring treatment
    • Clinically significant liver disease
    • Live, attenuated vaccine within 4 weeks before study treatment infusion on Day 1 of Cycle 1 or anticipation that such a live, attenuated vaccine will be required during the study. Live vaccines during the study and until participants B cells recover are prohibited
    • Any active infection within 7 days prior to Cycle 1 Day 1 that would impact participant safety
    • Suspected active or latent tuberculosis
    • Positive test results for chronic hepatitis B infection, hepatitis C, or the human T-lymphotropic virus type 1 (HTLV-1)
    • History of progressive multifocal leukoencephalopathy

    ADDITIONAL RESOURCES

    Contact an MSL
    Submit Medical Inquiry
    View Related Clinical Trials

    ID: NCT06047080

    View on ClinicalTrials.gov
    Study Site Locations

    Study Site Locations

    Explore the map to find active sites closest to your location or search by your ZIP code.

    ADDITIONAL RESOURCES

    Contact an MSL
    Submit Medical Inquiry
    View Related Clinical Trials

    ID: NCT06047080

    View on ClinicalTrials.gov

    60 Results

      Enrollment and Resources

      Enrollment & Resources

      Enrollment

      For more information on eligibility criteria, view the study or reach out to our team.

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      Phone

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      (US and Canada)

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      Email

      [email protected]

      Email Us

      ADDITIONAL RESOURCES

      Contact an MSL
      Submit Medical Inquiry
      View Related Clinical Trials

      ID: NCT06047080

      View on ClinicalTrials.gov

      Resources

      ClinicalTrials.gov

      Learn more about this trial (NCT06047080) on ClinicalTrials.gov.

      Visit CT.gov

      Patient Resources

      Genentech offers a place for patients, relatives, and caregivers to learn more about clinical trials.

      Visit Site

      Information is consistent with ClinicalTrials.gov as of June 02, 2026. Products under investigation have not been approved for use outside of the clinical trial setting. This information is presented only for the purposes of providing an overview of clinical trials and should not be construed as a recommendation for use of any product for unapproved purposes.

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      • AD
        Alzheimer's disease

      • ABC
        advanced breast cancer

      • bADLs
        Basic activities of daily living

      • ISLT
        International Shopping List Test

      • MCI
        Mild cognitive impairment

      • CV
        coefficient of variation

      • HEX
        cell hexagonality

      • nAMD
        neurovascular age-related macular degeneration

      • PDS
        Port Delivery System

      • Q24W
        once every 24 weeks

      • BMI
        Body mass index

      • HbA1c
        hemoglobin A1C

      • HOMA-IR
        Homeostasis Model Assessment of Insulin Resistance

      • NLM
        National Library of Medicine

      • QUICKI
        Quantitative Insulin Sensitivity Check Index

      • SC
        Subcutaneous

      • SGLT-2
        sodium-glucose cotransporter-2

      • SMBG
        Self-Monitored Blood Glucose

      • T1DM
        Type 1 Diabetes Mellitus

      • T2DM
        Type 2 diabetes mellitus

      • AE
        adverse events

      • AESI
        Adverse Events of Special Interest

      • MDD
        major depressive disorder

      • PHQ-9
        Patient Health Questionnaire-9

      • SAE
        serious adverse events

      • ABR
        Annualized Bleed Rate

      • CBR
        clinical benefit rate

      • CDK4/6i
        cyclin-dependent kinase 4 and 6 inhibitor

      • CNS
        central nervous system

      • CR
        complete response

      • DOR
        duration of response

      • ER
        estrogen receptor

      • HER2
        human epidermal growth factor receptor 2

      • HER2-
        human epidermal growth factor receptor 2-negative

      • HR
        hormone receptor

      • HR+
        hormone receptor-positive

      • HRQoL
        health-related quality of life

      • mut
        mutated

      • NIS
        non-interventional study

      • ORR
        objective response rate

      • OS
        overall survival

      • PFS
        progression-free-survival

      • PIK3CA
        phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha

      • PIK3CAm
        PIK3CA-mutated

      • PK
        pharmacokinetics

      • PROs
        patient-reported outcomes

      • SD
        stable disease

      • SoC
        standard of care

      • VWD
        von Willebrand disease

      • WHO
        World Health Organization

      • T2D
        Type 2 diabetes

      • T1D
        Type 1 Diabetes

      • ADA
        anti-drug antibody

      • DXA
        Dual-energy X-ray Absorptiometry

      • ASCVD
        atherosclerotic cardiovascular disease

      • FGF21
        fibroblast growth factor 21

      • SHTG
        severe hypertriglyceridemia

      • TG
        triglycerides

      • MASH
        metabolic dysfunction-associated steatohepatitis

      • NAFLD
        non-alcoholic fatty liver disease

      • NAS
        NAFLD Activity Score

      • NASH
        nonalcoholic steatohepatitis

      • pmMS
        partial modified Mayo

      • CD
        Crohn's disease

      • CMV
        cytomegalovirus

      • HIV
        human immunodeficiency virus

      • HBV
        Hepatitis B

      • HCV
        Hepatitis C

      • TB
        tuberculosis

      • UC
        ulcerative colitis

      • TL1A
        tumor necrosis factor-like ligand 1A

      • mMS
        modified Mayo Score

      • APS
        average daily abdominal pain scores in the past week

      • CDAI
        Crohn’s Disease Activity Index

      • IBDQ
        Inflammatory Bowel Disease Questionnaire

      • SF
        stool frequency subscore

      • PBO
        Placebo

      • EASI
        Eczema Area and Severity Index

      • IGA
        Investigator Global Assessment

      • NRS
        Numerical Rating Scale

      • IM
        intramuscular

      • IL
        intralesional

      • PDE-4
        Phosphodiesterase-4

      • ACE
        angiotensin-converting enzyme

      • ARBs
        angiotensin II receptor blockers

      • ASO
        Antisense Oligonucleotide

      • CKD-EPI
        Chronic Kidney Disease Epidemiology Collaboration

      • eGFR
        Estimated Glomerular Filtration Rate

      • FACIT-F
        Functional Assessment of Chronic Illness Therapy-Fatigue subscale

      • g/day
        gram per day

      • g/g
        gram per gram

      • GIP
        Glucose-dependent Insulinotropic Polypeptide

      • GLP-1
        Glucagon-like Peptide-1

      • IgAN
        IgA nephropathy

      • mg/day
        milligrams per day

      • TEAEs
        Treatment-Emergent Adverse Events

      • UPCR
        Urine Protein-to-Creatinine Ratio

      • AEs
        Adverse events

      • ALT
        Alanine aminotransferase

      • AST
        Aspartate aminotransferase

      • C-SSRS
        Columbia-Suicide Severity Rating Scale

      • DMT
        Disease-modifying therapy

      • ECG
        Electrocardiogram

      • EDSS
        Expanded Disability Status Scale

      • Gd
        Gadolinium

      • IPMSSG
        International Pediatric Multiple Sclerosis Study Group

      • MRI
        Magnetic resonance imaging

      • MS
        Multiple sclerosis

      • PD
        Pharmacodynamic

      • PPMS
        Primary progressive multiple sclerosis

      • RMS
        Relapsing multiple sclerosis

      • SI
        Suicidal ideation

      • SPMS
        Secondary progressive multiple sclerosis

      • CYP3A4
        cytochrome-p450-3a4

      • ADAS-Cog-13
        Alzheimer's Disease Assessment Scale-Cognition 13

      • ADAs
        Anti-drug antibodies

      • ADCS-ADL
        Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory

      • ARIA
        Amyloid-related imaging abnormalities

      • CDR-GS
        Clinical Dementia Rating, Global Score

      • CDR-SB
        Clinical Dementia Rating, Sum of Boxes

      • CSF
        Cerebrospinal fluid

      • GFAP
        Glial fibrillar acidic protein

      • iADRS
        Integrated Alzheimer's Disease Rating Scale

      • IRR
        Infusion-related reactions

      • MMSE
        Mini-Mental State Examination

      • PET
        Positron emission tomography

      • RBANS DMI
        Repeatable Battery for the Assessment of Neuropsychological Status Delayed Memory Index

      • EORTC QLQ-C30
        European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire

      • PRO-CTCAE
        Patient-Reported Outcomes Common Terminology Criteria for Adverse Events

      • TTCD
        Time to Confirmed Deterioration

      • AJCC
        American Joint Committee on Cancer Staging System

      • ECOG
        Eastern Cooperative Oncology Group

      • FFPE
        formalin-fixed, paraffin-embedded

      • RECIST
        Response Evaluation Criteria in Solid Tumors

      • NSCLC
        non-small cell lung cancer

      • BICR
        blinded independent central review

      • CD137
        Cluster of Differentiation 137

      • EORTC QLQ-LC13
        European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire-Supplemental Lung Cancer Module

      • KRAS G12C
        Kirsten rat sarcoma viral oncogene homolog G12C

      • PD-L1
        Programmed death-ligand 1

      • RAS
        RAt Sarcoma

      • RT
        Radiation therapy

      • DOCR
        duration of complete response

      • DFS
        disease-free survival

      • EFSeff
        event-free survival efficacy causes

      • FACT-Lym LymS
        lymphoma subscale within the functional assessment of cancer therapy-Lymphoma questionnaire

      • IPI
        international prognostic index

      • IRF
        Independent Review Facility

      • Pola-R-CHP
        polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone

      • LBCL
        large B-cell lymphoma

      • PROMIS-29
        Patient-Reported Outcomes Measurement Information System-29

      • ESR1nmd
        ESR1 no-mutation-detected

      • IV
        intravenous

      • II
        2

      • ECD
        endothelial cell density

      • III
        3

      +