Pre-operative Nivolumab and Ipilimumab, Followed by Post-operative Nivolumab, for MSI/dMMR Oeso-g… (NCT04006262) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Pre-operative Nivolumab and Ipilimumab, Followed by Post-operative Nivolumab, for MSI/dMMR Oeso-gastric Adenocarcinoma.
France32 participantsStarted 2019-10-23
Plain-language summary
This is a non-randomized study, open label phase II study. The purpose of this study is to evaluate the complete pathologic response rate (cPRR) with neoadjuvant nivolumab and ipilimumab combination in patients with MSI and/or dMMR localized oeso-gastric cancer.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Signed and dated informed consent,
✓. Age ≥18 years to ≤75 years of age,
✓. Histologically proven non-metastatic gastric adenocarcinoma or of the oeso-gastric junction T2 to T4, Nx, M0 after thoraco-abdominopelvic computed tomography (CT) and echo-endoscopy,
✓. Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, tumor biopsies, and other requirements of the study,
✓. dMMR (protein expression by immunohistochemistry \[ICH\] and/or MSI by polymerase chain reaction \[PCR\]), MMR and/or MSI tumors should be assessed per local guidelines: ICH with two (anti-MLH1 and anti-MSH2 or anti-MSH6, and antiPMS2) or four antibodies (anti-MLH1, anti-MSH2, anti-MSH6, and anti-PMS2) and/or PCR (with PROMEGA: BAT- 25, BAT-26, NR-21, NR-24, and NR-27) by the investigators prior to screening, Extinct MLH1 (+/- PMS2), MSH2 (+/- MSH6), MSH6, or PMS2 alone protein expression by IHC (dMMR), and/or tumor with ≥ 2 instable MSI-H markers on PCR: BAT25, BAT26, NR21, NR24, and NR27 (pentaplex panel is recommended),
✓. The Eastern Cooperative Oncology Group Performance status (ECOG PS) 0-1, for patients over 70 years ECOG PS of 0;
✓. Hematological status: absolute neutrophil count (ANC) ≥1.5 x 109/L; platelets ≥100 x 109/L; hemoglobin ≥9 g/dL,
✓. Adequate renal function: serum creatinine level \<120 µM, clearance \> 50ml/min (Modification of the Diet in Renal Disease \[MDRD\] or Cockcroft and Gault),
✕. Treatment with any investigational medicinal product within 28 days prior to study entry,
✕. Major surgical procedure within 4 weeks prior to initiation of study treatment,
✕. 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,
✕. Metastases (M stage disease) whatever the location,