GO44145: Glofitamab in previously untreated large B-cell lymphoma (SKYGLO)

• Research type

  Research Study

• Full title

  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

• IRAS ID

  1007783

• Contact name

  Ethan Montenegro

• Contact email

  welwyn.uk_ethics@roche.com

• Sponsor organisation

  F. Hoffmann-La Roche AG

• Clinicaltrials.gov Identifier

  2023-504028-24-00

• Research summary

  Non-Hodgkin lymphoma (NHL) is the most common hematologic malignancy in the world and the 13th most common cancer overall. Diffuse large B-cell lymphoma (DLBCL) is the most common NHL.
  The purpose of this study is to compare the effects, good or bad, of glofitamab with Pola-R-CHP vs Pola-R-CHP alone in patients with a certain type of cancer called large B-cell lymphoma (LBCL), to find out which is better. The combination of glofitamab with Pola-R-CHP has the potential to provide additional benefit to patients in the first-line setting.
  In this study, eligible participants will receive glofitamab plus Pola-R-CHP (Arm A) or Pola-R-CHP alone (Arm B).
  Approximately 70 participants will take part from the UK and 1130 worldwide.
  Glofitamab is a type of medication called a T cell-bispecific antibody. Antibodies are proteins naturally produced by your body as part of the immune response. Glofitamab is an antibody that has been engineered to recognise and attach to two specific proteins: one on the surface of cancer cells and one on the surface of a type of immune cell called a T cell.
  Glofitamab is an experimental study drug, which means health authorities have not approved it alone or in combination with Pola-R-CHP for the treatment of LBCL.
  Polatuzumab vedotin, rituximab, and CHP are drugs that have already been approved alone and in combination by some health authorities for the treatment of different types of cancer.
  Following infusion of glofitamab, participants may experience a side effect called cytokine-release syndrome (CRS), that can occur in the hours or days following the infusion. If that happens, tocilizumab may be given intravenously (into the vein) to treat the symptoms of this side effect.
  Participants total time in the study will depend on how their cancer responds to treatment. This could range from 1 day to more than 60 months.
  The study is sponsored by F. Hoffman La Roche

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  23/LO/0503

• Date of REC Opinion

  14 Sep 2023

• REC opinion

  Further Information Favourable Opinion