CompletedPhase 2

Avelumab Plus Cetuximab in Pre-treated RAS Wild Type Metastatic Colorectal Cancer

Italy77 participantsStarted 2018-08-10

Plain-language summary

This is a non-profit phase II, open-label, single-arm study of cetuximab plus avelumab in patients with RAS WT mCRC treated in first line with chemotherapy in combination with an anti- EGFR drug that have had a clinical benefit (complete or partial response) from treatment.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Signed written informed consent before any trial-related procedure is undertaken that is not part of the standard patient management
✓. Male or female subjects aged ≥ 18 years 3.Histologically proven diagnosis of colorectal adenocarcinoma.

Exclusion criteria

✕. Any contraindication to cetuximab and/or avelumab.
✕. Past or current history of malignancies other than colorectal carcinoma, except for curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix.
✕. Pregnancy 4.Breastfeeding
✕9.Vaccination within 4 weeks of the first dose of avelumab and cetuximab and while on treatment is prohibited except for administration of inactivated vaccine (i.e. inactivated influenza vaccine) 20. Legal incapacity or limited legal capacity.

What they're measuring

overall survival

Timeframe: 24 months

Trial details

NCT IDNCT04561336

SponsorUniversity of Campania Luigi Vanvitelli

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-11-14

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