Active — Not RecruitingPhase 1/2

MG1 Maraba/MAGE-A3, With and Without Adenovirus Vaccine With Transgenic MAGE-A3 Insertion in Incurable MAGE-A3-Expressing Solid Tumours

Canada56 participantsStarted 2015-01-22

Plain-language summary

This research is being done because these viruses have been shown to shrink tumours in animals and human tumour samples by selectively killing cancer cells and creating an immune response to the tumour antigen contained in the viruses. This effect has been shown to increase when the AdMA3 virus is given first. It is not clear if this treatment will offer better results than standard treatment.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Non-small cell lung cancer (NSCLC) specifically adenocarcinoma and squamous cell carcinoma.
✓. Breast cancer
✓. Esophageal/GEJ cancer/gastric

Exclusion criteria

✕. History of significant neurologic or psychiatric disorder (e.g. uncontrolled psychotic disorders) which would impair the ability to obtain consent or limit compliance with study requirements.
✕. Active uncontrolled or serious infection (viral, bacterial or fungal) or a history of opportunistic infection associated with an immunodeficient state.
✕. Significant immunodeficiency due to underlying illness (e.g. known HIV/AIDS) and/or medication (e.g. systemic corticosteroids).
✕. Known myeloproliferative disorders requiring systemic therapy.
✕. Other medical conditions that might be aggravated by study treatment.
✕. Women who are pregnant or nursing an infant
✕. Children \< 12 months old
✕. Anyone with significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication (e.g. systemic corticosteroids)

What they're measuring

Phase I: Toxicity as measured by adverse events

Timeframe: 3 years

Phase II: Objective tumour response rate (ORR) using RECIST v1.1.

Timeframe: 16 weeks

Trial details

NCT IDNCT02285816

SponsorCanadian Cancer Trials Group

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2019-09-19

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