Armo’s Randomised Trial Inducing Stimulated T cells

• Research type

  Research Study

• Full title

  A Randomized Phase 3 Study of AM0010 in Combination with FOLFOX Compared with FOLFOX Alone as Second-line Therapy in Patients with Metastatic Pancreatic Cancer that has Progressed During or Following a First-Line Gemcitabine Containing Regimen

• IRAS ID

  220727

• Contact name

  Pippa Corrie

• Contact email

  pippa.corrie@addenbrookes.nhs.uk

• Sponsor organisation

  ARMO BioSciences Inc.

• Eudract number

  2016-003858-33

• Clinicaltrials.gov Identifier

  NCT02923921

• Duration of Study in the UK

  2 years, 5 months, 31 days

• Research summary

  Pancreatic adenocarcinoma carries an extremely poor prognosis; it is the fourth leading cause of cancer-related death in Europe and the United States. The 5-year survival rate for this disease is less than 5%. The first-line standard-of-care for patients with metastatic pancreatic cancer has been single-agent gemcitabine from 1993–2013. In patients with previously untreated metastatic (stage 4) disease, modest improvements in survival have recently been achieved with FOLFIRINOX (folinic acid, 5 – fluorouracil [5-FU], irinotecan, and oxaliplatin) as well as gemcitabine+nabPaclitaxel compared with gemcitabine alone. The expected median overall survival in patients receiving the available 2nd line therapy in metastatic pancreatic cancer is between 5-6 months. Second line chemotherapy options are extremely limited.

  The main aim of this trial is to determine if pegylated recombinant humanised IL10 (AM0010), in combination with FOLFOX (oxaliplatin, 5-FU plus leucovorin) chemotherapy, improves survival of metastatic pancreatic cancer patients who have progressed during or following first-line gemcitabine containing chemotherapy.

  Eligible patients will be randomly assigned to one of 2 treatment arms:
  ARM 1: AM0010 (5 µg/kg) SQ d1-5 and d 8 - 12 plus FOLFOX every 14 days for up to 6 months (12 cycles) or treatment intolerance, followed by maintenance AM0010 (10µg/kg) alone 5 days on 2 days off until no further clinical benefit
  ARM 2: FOLFOX alone for up to 6 months (12 cycles), treatment intolerance or disease progression, whichever occurs soonest

  The primary outcome measure of this open label study is overall survival; secondary end points include progression-free survival, objective response rate, safety and tolerance. Blood and archival tumour tissue will be collected for translational studies.
  This is an international commercial study sponsored by ARMO BioSciences. Approximately 566 patients will take part in the study, globally. NIHR portfolio adoption is being applied for.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  17/EE/0080

• Date of REC Opinion

  9 Jun 2017

• REC opinion

  Further Information Favourable Opinion