IMM-101-008 Long Term Follow Up Study of Phase I IMM-101-001

• Research type

  Research Study

• Full title

  An Open Label Long term Follow up Study for Patients with Melanoma who were Previously Enrolled in the Phase I Study IMM-101-001

• IRAS ID

  91056

• Contact name

  Angus Dalgleish

• Sponsor organisation

  IMMODULON THERAPEUTICS LIMITED

• Eudract number

  2011-003967-31

• ISRCTN Number

  not issued

• Research summary

  The proposed study will explore the long term safety and tolerability of continued administration of IMM-101 in patients who were previously enrolled in the Phase I safety and tolerability study IMM-101-001. IMM-101-001 was a first-in-human, open-label, dose-escalation, intra-patient, placebo controlled study, in adult patients with confirmed diagnosis of stage III or IV melanoma to evaluate the safety and tolerability of three doses of IMM-101. The study also characterized local responses to this immunotherapeutic agent in order to delineate unexpected / unacceptable local reactions from those indicative of an appropriate immunological response in this patient group.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  11/LO/1772

• Date of REC Opinion

  30 Nov 2011

• REC opinion

  Favourable Opinion