A novel phase I/IIa open-label study of IMM-101 in combination with selected standard of care regimens in patients with metastatic cancer or unresectable cancer at study entry

Autor:	David Stanbury, David Cunningham, Laura Rosa Brunet, Satvinder Mudan, Jean-Yves Blay, Aurélien Marabelle
Rok vydání:	2017
Předmět:	Oncology Cancer Research medicine.medical_specialty Standard of care business.industry Cancer medicine.disease Open label study Internal medicine medicine In patient Line (text file) business
Zdroj:	Journal of Clinical Oncology. 35:e14627-e14627
ISSN:	1527-7755 0732-183X
DOI:	10.1200/jco.2017.35.15_suppl.e14627
Popis:	e14627 Background: The MODULATE (IMM-101-011, EUDRACT 2016-001459-28) trial recruits patients with metastatic or unresectable cancer considered for a new line of recognised SOC (1st, 2nd or 3rd line and beyond). IMM-101 is a heat-killed whole cell Mycobacterium obuense (National Collection of Type Cultures [NCTC] 13365) for intradermal injection. Methods: The primary objective of the study is to provide safety data for IMM-101 in combination with several selected SOC regimens. The secondary objectives of the study are to provide safety and tolerability data for extended administration (beyond 28 weeks) of the immunomodulator IMM-101 in combination with a number of selected SOC regimens. A particular focus of the study is to evaluate safety data for the combination of IMM 101 with anti PD1 and with anti-CTLA 4. Pre-clinical data suggests that IMM-101 increases the response to PD1 in a syngeneic in vivo model of EMT6 breast cancer. Furthermore, in a syngeneic B16 melanoma tumour model the combination of IMM-101 with anti-PD1 antibodies increased T effector cells in the tumour and reduced the numbers of T-regulatory cells; significantly shifting the T-cell ratio towards anti-tumour efficacy. Results: The study aims through its translational programme to evaluate the best combination partner for IMM-101 due to the SOCs immunogenic cell death capabilities and supportive immunological activities. MODULATE will monitor selected markers of tumour burden and immunological status in patients taking IMM-101. Conclusions: The MODULATE study will initially recruit patients in the UK and France with US sites added in Q4 2017. Clinical trial information: NCT03009058. [Table: see text]
Databáze:	OpenAIRE
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