MOMENTUM
Research type
Research Study
Full title
A Phase I/II Trial of MEDI4736 in Combination with MGN1703 in Subjects with Gastrointestinal Tumours
IRAS ID
186364
Contact name
Cunningham David
Contact email
Sponsor organisation
The Royal Marsden NHS Foundation Trust
Eudract number
2015-003058-42
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
This is a single centre, non-randomised, phase I/II clinical trial investigating the safety and efficacy of two immunotherapy drugs (MEDI4736 and MGN1703) given in combination for the treatment of patients with locally advanced or metastatic gastrointestinal tumours that have progressed to at least one line of standard treatment.
MEDI4736 is a PD-L1 inhibitor that activates the adaptive immune system while MGN1703 is a TLR-9 agonist that activates the innate immune system. They have been previously used in cancer patients and demonstrated to be safe and active. However, they have never been tested in combination.
The study includes a dose escalation (phase I) and a dose expansion part (phase II). The aim of thephase I study is to assess whether combining these two drugs is feasible, to find the maximum tolerated dose and to evaluate type, frequency and severity of side effects. The aim of the phase II study is to further assess the safety of this combination treatment and its anti-tumour activity in specific gastrointestinal cancers.All eligible patients will receive a maximum of 49 weeks of treatment. However, treatment could be continued indefinitely if satisfactory disease control is achieved and treatment is well tolerated. We anticipate enrolling 9 to 24 patients in the phase I study and 60 to 80 patients in the phase II study.
The study includes a biomarker research substudy. Archived tumour samples and blood samples at baseline and at several time points during treatment will be collected for all eligible patients. Moreover, patients who are enrolled in the phase II study will undergo tumour biopsies at baseline and 7 weeks after the start of treatment (these are optional for patients enrolled in the phase I study). An additional research biopsy at the time of tumour progression is optional for all study patients.
REC name
London - Chelsea Research Ethics Committee
REC reference
15/LO/1988
Date of REC Opinion
15 Feb 2016
REC opinion
Further Information Favourable Opinion