The goal of this investigational, multicenter, open-label randomized, two-stage phase II study is to evaluate neoadjuvant pembrolizumab with a watch-and-wait approach in patients with localized deficient mismatch repair / high microsatellite instability (dMMR/MSI-H) colorectal cancer (CRC). The PREMICES trial is based on the hypothesis that non-operative management is effective for dMMR/MSI-H localized CRC when treated with neoadjuvant pembrolizumab.
Eligible patients will be randomized in a 1:1 ratio to receive either pembrolizumab with a watch-and-wait approach (experimental arm A) or the standard strategy of surgical resection ± adjuvant chemotherapy (arm B).
Signed and dated informed consent (IC),
Aged ≥18 years,
An Eastern Cooperative Oncology Group Performance status (ECOG PS) of 0 or 1,
Newly diagnosed, histologically confirmed colonic or upper third rectal adenocarcinoma, NB: material must be available from biopsy done during colonoscopy.
Tumor that is not readily resectable,
Bifocal colorectal adenocarcinoma,
Locally advanced middle or low rectal cancer (<10 cm from the anal verge on MRI, sagittal slide) staged as cT3/T4 and/or N+ and/or with predictive circumferential margin >2 mm on pretreatment MRI, NB: for rectal cancers, the margin of the tumor relative to the anal margin should be indicated on the endoscopy report,
Major surgical procedure within 4 weeks prior to the first dose of study treatment,
GERCOR - Multidisciplinary Oncology Cooperative Group
Lead sponsor
Fondation ARCAD
Collaborator