INCMGA 0012-303 - POD1UM-303

• Research type

  Research Study

• Full title

  A Phase 3 Global, Multicenter, Double-Blind Randomized Study of Carboplatin-Paclitaxel With INCMGA00012 or Placebo in Participants With Inoperable Locally Recurrent or Metastatic Squamous Cell Carcinoma of the Anal Canal Not Previously Treated With Systemic Chemotherapy (POD1UM-303/InterAACT 2)

• IRAS ID

  286160

• Contact name

  Sheela Rao

• Contact email

  sheela.rao@rmh.nhs.uk

• Eudract number

  2020-000826-24

• Clinicaltrials.gov Identifier

  NCT04472429

• Clinicaltrials.gov Identifier

  139,333, IND Number

• Duration of Study in the UK

  3 years, 5 months, 21 days

• Research summary

  INCMGA00012 is an investigational drug that is being studied by Incyte Corporation for use in the treatment of Squamous Carcinoma of the Anal Canal (SCAC) that cannot be removed by surgery.

  This research study is for participants diagnosed with anal cancer that has come back either in same place or it has spread to other areas of the body and it cannot be removed by surgery. This study is designed to test whether the study drug, INCMGA00012, combined with chemotherapy is safe and effective when compared to placebo combined with chemotherapy.

  This study is double-blinded, which means that during the study the participant and study doctor will not know if they are receiving INCMGA00012 or placebo (“study drug”). Placebo looks like INCMGA00012 but contains no drug.

  About 300 participants worldwide will be enrolled in this study. Participants may receive study treatment (chemotherapy and INCMGA00012 or placebo) for up to 24 weeks (6 cycles) and additional study drug (INCMGA00012 or placebo) for up to an additional 28 weeks (7 additional cycles). Overall, they may receive about one year (up to 13 cycles) of study drug as long as their cancer is not getting worse or they do not have serious side effects. Their total participation in this study may last up to about 3 years including long term follow-up.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  20/LO/0995

• Date of REC Opinion

  3 Sep 2020

• REC opinion

  Favourable Opinion