CAVE-2 GOIM Study: a Clinical Study of the Combination of Avelumab Plus Cetuximab as Rechallenge … (NCT05291156) | Clinical Trial Compass
UnknownPhase 2
CAVE-2 GOIM Study: a Clinical Study of the Combination of Avelumab Plus Cetuximab as Rechallenge Strategy
Italy173 participantsStarted 2022-07-21
Plain-language summary
This is a non-profit phase II, randomized clinical study of the combination of avelumab plus cetuximab as rechallenge strategy, compared to cetuximab alone, in pre-treated RAS/BRAF wild type metastatic colorectal cancer patients (according to liquid biopsy at baseline). Patients have been treated in first line with chemotherapy in combination with cetuximab and 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.
✓. Histologically proven diagnosis of colorectal adenocarcinoma.
✓. Diagnosis of metastatic disease.
✓. RAS (NRAS and KRAS exon 2,3 and 4) and BRAF wild-type in liquid biopsy at screening (according to NGS, Foundation/Roche).
✓. Efficacy of a first line therapy containing cetuximab with a major response achieved (i.e. complete or partial response according to RECIST criteria v1.1).
✓. Received a second line therapy.
✓. More than 4 months since the last dose of cetuximab administered in first line treatment before randomization.
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.
✕. Breastfeeding.
✕. Participation in a clinical study or experimental drug treatment within 30 days before enrollment.
✕. Subjects receiving immunosuppressive agents (such as steroids) for any reason, should be tapered off these drugs before initiation of the trial treatment, with the exception of:
✕. All subjects with brain metastases, except those meeting the following criteria:
✕. Prior organ transplantation, including allogeneic stemcell transplantation