Neoadjuvant Pembrolizumab With a Watch-and-wait Strategy for dMMR/MSI-H Localized Colon Cancer: P… (NCT06646445) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Neoadjuvant Pembrolizumab With a Watch-and-wait Strategy for dMMR/MSI-H Localized Colon Cancer: PREMICES Study.
France60 participantsStarted 2025-09
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Radiological tumor assessment at screening performed within 21 days before inclusion according to RECIST v1.1 by chest, abdomen, and pelvis (TAP- CT) showing resectable localized disease (cT0-4 cN0-2 cM0) and no metastatic disease,
✓. dMMR and/or MSI-high (MSI-H) tumor status as follows:
✓. Adequate hematological status, renal, and liver function obtained within 14 days prior to randomization of study treatment:
✓. absolute neutrophil count (ANC) ≥1.5 x 10\^9/L; platelets ≥100 x 10\^9/L; hemoglobin ≥9 g/dL,
Exclusion criteria
✕. Tumor that is not readily resectable,
What they're measuring
1
The rate of success of the experimental strategy at 6 months or after two successive colonoscopies (corresponding to timepoint at 6 months from the experimental strategy) following randomization.
Timeframe: 6 months
Trial details
NCT IDNCT06646445
SponsorGERCOR - Multidisciplinary Oncology Cooperative Group
✕. 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,
✕. Pre-existing hemostatic disorder or medical condition requiring chronic anticoagulation that cannot be interrupted for the purpose of study specified tumor resection or endoscopic biopsies,
✕. Metastases (stage IV disease),
✕. Has history of uncontrolled or symptomatic cardiac disease,
✕. Prior treatment with an anti-PD(L)1, anti-LAG-3, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways, including prior therapy with anti-tumor vaccines or other immuno-stimulatory antitumor agents,