iRECIST Evaluation's Relevance for DCR in MMR/MSI Metastatic Colorectal Cancer Patients on Nivolu… (NCT03350126) | Clinical Trial Compass
Active — Not RecruitingPhase 2
iRECIST Evaluation's Relevance for DCR in MMR/MSI Metastatic Colorectal Cancer Patients on Nivolumab and Ipilimumab
France57 participantsStarted 2017-12-04
Plain-language summary
This is a non-randomized study, open label phase II study. The purpose of this study is to evaluate disease control rate (DCR) by RECIST and iRECIST at 12 weeks.
Evaluation of RECIST and iRECIST will be done in each center in order to choose the optimal therapy (Assessment by Investigators).
A centralized evaluation of RECIST and iRECIST, will be organized in Saint-Antoine.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Signed and dated informed consent,
✓. For female patients of childbearing potential, negative pregnancy test within 7 days before starting the study drug,
✓. Men and women are required to use adequate birth control during the study (when applicable):
✓. Histologically proven metastatic adenocarcinoma of the colon and/or rectum,
✓. Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, tumor biopsies, and other requirements of the study,
✓. dMMR DNA (protein expression by ICH and/or MSI by PCR):
✓. Age ≥18 years,
✓. The Eastern Cooperative Oncology Group Performance status (ECOG PS) 0-1,
. Other serious and uncontrolled non-malignant disease (including active infection),
✕. Other concomitant or previous malignancy, except: i/ adequately treated in-situ carcinoma of the uterine cervix, ii/ basal or squamous cell carcinoma of the skin, iii/ cancer in complete remission for \>5 years,