209229 INDUCE 3 (Pembro +/- GSK3359609 in recurrent/metastatic HNSCC)

• Research type

  Research Study

• Full title

  A Randomized, Double-blind, Adaptive, Phase II/III Study of GSK3359609 or Placebo in Combination with Pembrolizumab for First-Line Treatment of PD-L1 Positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

• IRAS ID

  263318

• Contact name

  Piyush Mehta

• Contact email

  piyush.x.mehta@gsk.com

• Eudract number

  2019-002263-99

• Clinicaltrials.gov Identifier

  NCT04128696

• Clinicaltrials.gov Identifier

  143221, IND

• Duration of Study in the UK

  3 years, 8 months, 25 days

• Research summary

  Research Summary
  Head and neck squamous cell carcinoma (HNSCC) is a commonly occurring cancer. Despite treatment advances more than half of patients eventually experience a return of their disease (recurrence) which has likely spread (metastatic). With current chemotherapy the expected median survival for patients with this disease remains under 15 months.
  GSK3359609 and Pembrolizumab are two investigational medicines which work by stimulating the immune system to kill the cancer. Pembrolizumab is approved in the USA and other countries for treatment of HNSCC.
  The purpose of this study is to expand on clinical data and evaluate further if adding GSK3359609 to pembrolizumab improves how well pembrolizumab works in people with recurrent/metastatic HNSCC with the aim to prolong patient survival.
  Participants will undergo screening to assess their eligibility, which involves review of blood tests, vital signs, ECG, echocardiogram, physical exam and disease assessment scans (such as a CT-scan). All eligible participants will receive Pembrolizumab. Additionally, a computer will decide if participants will also receive GSK3359609 or a placebo (dummy drug). Neither the participants nor the study doctor can choose the treatment or will know what treatment the participant is receiving.
  Participants will receive two treatments every 3 weeks (a cycle), each one given over 30 mins via intravenous injection. Before each treatment, a safety blood sample will be collected, participants will complete a number of questionnaires and have a brief physical exam. Participants will be treated until disease progression, unacceptable side effects or death. Some additional blood samples will also be collected to help understand the effects of GSK3359609.
  It is anticipated most participants will be in the study for approximately 4-9 months but could receive up to a maximum of 35 cycles or 2 years of treatment. Once treatment has stopped participants will be followed-up to document their further treatment(s) and survival information.

  Lay summary of study results
  A lay summary for this trial can be found on the "trialsummaries.com" portal using the link "https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbfpRKZVa7OWyQIFoKflfg1pt-2FHXflsiUe6hLYTyAdKtjt4K1w-2BU2LUxU9Be2OWVTYHHV5u0AXb7ndELoWtxHAmrXJCcQoDTWUhXZ9NDHhLVCqICx_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YJfQ9-2B7fuXzNis7hpYNQrcDtMQK8w9EzOO34X3JXocmwiXzKbb5NVxBcjT-2FNWwND3U0wyns-2Ff5yLjkr1At0nV6zrQVJdT-2FCPuBTWrwmj1BW-2B8mU1Yo3iknItA4p4b6lAFc2qhhO8RY-2BKCVlY7q8f45-2BKn0wW5FLN5GNLwBezBDRmg-3D-3D&data=05%7C02%7Ccambridgeeast.rec%40hra.nhs.uk%7Cfacb235083b14b9b6c9e08dc2e437118%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638436114389103446%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=fGiQzibSfGHUT2oWRclhSYnjKsr0ffweWjRhHOnfm9s%3D&reserved=0

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  19/EE/0353

• Date of REC Opinion

  10 Mar 2020

• REC opinion

  Further Information Favourable Opinion