mosunetuzumab + tiragolumab +/- atezolizumab for treatment of NHL

• Research type

  Research Study

• Full title

  A Phase IB/II Open-Label, Multicenter Study Evaluating The Safety, Efficacy, And Pharmacokinetics Of Mosunetuzumab In Combination With Tiragolumab With Or Without Atezolizumab In Patients With Relapsed Or Refractory B-Cell Non-Hodgkin Lymphoma

• IRAS ID

  302614

• Contact name

  David Cunningham

• Contact email

  David.Cunningham@rmh.nhs.uk

• Sponsor organisation

  F.Hoffmann-La Roche Ltd.

• Eudract number

  2021-001060-23

• Clinicaltrials.gov Identifier

  NCT05315713

• Clinicaltrials.gov Identifier

  IND Number, 120651

• Duration of Study in the UK

  4 years, 0 months, 0 days

• Research summary

  Summary of Research
  The purpose of this study is to test the safety and efficacy of mosunetuzumab in combination with tiragolumab (Arm 1) and the safety and efficacy of mosunetuzumab in combination with tiragolumab and atezolizumab (Arm 2) at different dose levels and schedules to find out what effects, good or bad, this drug combination has on participants and their cancer.

  Approximately 16 participants will take part in the study in the UK and 118 worldwide (92 participants taking part in Arm 1 and 26 participants in Arm 2).

  This is a non-randomized open-label study, Phase Ib/II

  This study will enroll patients with a history of hematologic malignancy that is expected to express the CD20 antigen, specifically Diffuse Large B-cell Lymphoma and Follicular Lymphoma.

  Total duration of study participation for each patient will be a maximum of 36 months.

  The study consists of three phases:
  Stage 1 – Screening

  Stage 2 – Treatment

  Stage 3 - Follow-up

  Summary of Results
  : https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fforpatients.roche.com%252Fen%252Ftrials%252Fcancer%252Fnon-hodgkins-lymphoma%252Fan-open-label--multicenter-study-evaluating-the-safety--95093.html%2523forpatients%2FNBTI%2FwJe6AQ%2FAQ%2F0a2a68f8-1d6b-46c7-8369-439a0707412a%2F2%2Fd6YDpqSaw7%23forpatients&data=05%7C02%7Capprovals%40hra.nhs.uk%7C44d633b5ed4c46dc0f6608dd30f34de9%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638720543724883359%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=L2gYPvepeaNNX7hv1AwcGrafKyrQLgX3LxqWYnmTsx8%3D&reserved=0

• REC name

  West of Scotland REC 1

• REC reference

  21/WS/0108

• Date of REC Opinion

  18 Oct 2021

• REC opinion

  Further Information Favourable Opinion