Phase 1/2 Study of G100 for Non-Hodgkin's Lymphoma Patients
Research type
Research Study
Full title
Phase 1/2 Study Of Intratumoral G100 With Or Without Pembrolizumab In Patients With Follicular Non-Hodgkin’s Lymphoma
IRAS ID
200316
Contact name
Ian Chau
Contact email
Sponsor organisation
Immune Design Ltd.
Eudract number
2015-005382-23
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 5 months, 17 days
Research summary
Lymphoma accounts for 4% of all new cancer diagnoses and is the sixth most common cancer in the UK. Follicular low grade non-Hodgkin’s lymphomas (NHL) respond to many different anti-cancer treatments including chemotherapy, biologics, and radiation, but despite this, remain incurable. Active immunotherapy (medications that stimulate the host’s own immune system to fight their own cancer) holds particular promise in that it has the potential to provide lifelong lasting protection against these malignancies and their recurrence through immunologic memory. In NHL, active immunotherapy approaches have led to significant tumour reduction and long-lasting disease-free intervals in some patients.
This study will evaluate the safety and efficacy of the study medication G100 in participants with NHL following standard local radiation therapy. In this study, G100 will be injected into tumours of follicular NHL participants in order to generate anti-tumour immune responses, and to see if the study medication causes the tumours to shrink.
The study will be conducted in two parts (dose escalation and dose expansion). In Part 1, the maximum tolerated dose (MTD) (i.e. the highest dose that can be taken without unacceptable side effects) will be determined and used to treat additional participants in Part 2. In Part 2 of the study, two groups of participants will be examined. In the first group, up to 24 participants will be randomised to receive either G100 alone or G100 and an additional anti-PD-1 (programmed cell death) antibody therapy called pembrolizumab. In the second group, a higher dose of G100 may be examined in up to 4 additional participants.
In total, this study plans to enrol up to 40 participants with follicular NHL at 14 sites in the UK, USA, Canada, France and Spain. The total duration of the study for each participant is expected to be approximately 1 year.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
16/NE/0166
Date of REC Opinion
28 Jun 2016
REC opinion
Further Information Favourable Opinion