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Phase III: Glofitamab in 1L LBCL (SKYGLO)

Clinical Trial Overview

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)^a

Secondary Endpoints

PFS as determined by the investigator^a
PFS as determined by the investigator and IRF for participants with International Prognostic Index (IPI) 3-5^a
Event-free survival efficacy causes (EFSeff)^b
Complete response (CR) rate^c
Objective response rate (ORR)^d
Overall survival (OS)^e
Duration of response (DOR)^f
Duration of complete response (DOCR)^g
Disease-free survival (DFS)^h
Serum concentration of glofitamabⁱ
Incidence of anti-drug antibodies (ADAs)^j
Proportion of participants experiencing a clinically meaningful improvement in physical functioning and fatigue (EORTC QLQ-C30) and lymphoma symptoms (FACT-Lym LymS)ⁱ
Time to deterioration in physical functioning and fatigue (EORTC QLQ-C30) and lymphoma symptoms (FACT-Lym LymS)ⁱ
Percentage of Participants with Adverse Events (AEs)^j

From randomization to the first occurrence of disease progression or relapse, or death due to any cause, whichever occurs first (up to approximately 65 months)
From randomization to the earliest occurrence of disease progression or relapse; death due to any cause; initiation of new anti-lymphoma treatment; or positive biopsy for residual disease after treatment completion (up to approximately 65 months)
At the end of treatment (up to approximately 65 months)
At treatment completion or discontinuation (up to approximately 65 months)
From randomization to death from any cause (up to approximately 65 months)
From the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to approximately 65 months)
From the first occurrence of a documented CR to disease progression or death, whichever occurs first (up to approximately 65 months)
From a documented CR at the end of treatment to disease progression or death, whichever occurs first (up to approximately 65 months)
Up to approximately 65 months
From randomization to the end of study (up to approximately 65 months)

ADAs= incidence of anti-drug antibodies; AE= adverse events; CR= complete response rate; DOR= duration of response; DOCR= duration of complete response; DFS= disease-free survival; EFSeff= event-free survival efficacy causes; EORTC QLQ-C30= European Organization for Research and Treatment of Cancer; FACT-Lym LymS= lymphoma subscale within the functional assessment of cancer therapy-Lymphoma questionnaire; IPI= international prognostic index; IRF= independent review facility; ORR= objective response rate; OS= overall survival; PFS= progression-free survival; Pola-R-CHP= polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone; LBCL= large B-cell lymphoma.

Glofitamab

Other names: RG 60262
Modality: CD20xCD3 T-cell engaging bispecific antibody

QUICK LINKS

Clinical Trial Overview

Inclusion and Exclusion Criteria

Enrollment and Resources

View on ClinicalTrials.gov

Inclusion and Exclusion Criteria

Key Inclusion Criteria

Key Exclusion 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

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

Enrollment & Resources

Enrollment

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

Web

ClinicalTrials.gov
Identifier: NCT06047080

Phone

1-888-662-6728
(US and Canada)

Email

[email protected]

Clinical Trial Site Locations

Clinical Trial Site Locations

For more information on recruitment status, or where the study is being conducted

Visit ClinicalTrials.gov

Information is consistent with ClinicalTrials.gov as of April 17, 2025. 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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