Study study type PathologyT1T0Patientssample sizesROB Results

mCRC - 1st line (L1) metastatic/advanced - colorectal cancer (mCRC) mCRC - 1st line (L1)

versus Bevacizumab plus FOLFOXIRI
atezolizumab plus FOLFOXIRI plus bevacizumab
AtezoTRIBE, 2022
  NCT03721653
RCTmCRC - 1st line (L1)atezolizumab plus FOLFOXIRI plus bevacizumabFOLFOXIRI plus bevacizumabPatients aged 18–75 years, with ECOG PS ≤2 if aged < 70 years, or ECOG PS 0 if aged 71–75 years145 / 73some concern
suggested
  • suggested 30 % decrease in progression or deaths (PFS) (PE)
1) The addition of atezolizumab to first-line FOLFOXIRI plus bevacizumab is safe and improved progression-free survival in patients with previously untreated metastatic colorectal cancer2) Pts with IS IC-high and/or TMB high pMMR mCRC seem to derive a survival benefit from adding atezo to FOLFOXIRI/bev as upfront treatment.
versus Standard of Care (SoC)
nivolumab plus SoC
CheckMate 9X8, 2024
  NCT03414983
RCTmCRC - 1st line (L1)nivolumab plus mFOLFOX6 plus bevacizumabmFOLFOX6 plus bevacizumabPatients aged at least 18 years with histologically confirmed mCRC not amenable to curative resection and no prior chemotherapy for metastatic disease127 / 68low
inconclusive
  • inconclusive 19 % decrease in progression or deaths (PFS) (PE)
The CheckMate 9X8 trial investigating first-line nivolumab plus SOC versus SOC in patients with mCRC did not meet its primary endpoint of PFS by BICR. Nivolumab plus SOC showed numerically higher PFS rates after 12 months, a higher response rate, and more durable responses compared with SOC alone, with acceptable safety
METIMMOX, 2024
  NCT03388190
RCTmCRC - 1st line (L1)nivolumab plus SOCSOCpreviously untreated, unresectable metastatic colorectal, MSS, no upper age limit,38 / 38some concern
no results
    no results
The investigational regimen did not improve the primary outcome for the intention-to-treat population but might benefit small subgroups of patients with previously untreated, metastatic microsatellite-stable colorectal cancer.
pembrolizumab alone
KEYNOTE-177, 2020
  NCT02563002
RCTmCRC - 1st line (L1)Pembrolizumabchemotherapy FOLFIRI or FOLFOX plus targeted therapytreatment-naïve U.S. patients with microsatellite instability-high (MSI-H) and/or mismatch repair-deficient (dMMR) metastatic colorectal cancer (mCRC)153 / 154some concern
conclusif
  • demonstrated 40 % decrease in progression or deaths (PFS) (PE)
this study demonstrated a doubling in progression-free survival (PFS) with pembrolizumab versus standard chemotherapy in patients with newly diagnosed MSI-H mCRC leading to FDA approval for pembrolizumab in first line treatment of patients with unresectable or metastatic MSI-H/dMMR CRC
durvalumab based treatment, Standard of Care (SoC)
Columbia 1, 2024
  NCT04068610
RCTmCRC - 1st line (L1)durvalumab plus ocleclumab plus SOCSOCpatients ≥ 18 years in First line therapy of Metastatic Microsatellite-stable Colorectal Cancer with an ECOG of 0 or 126 / 26low
inconclusive
  • inconclusive 80 % increase in objective responses (ORR),objective responses (ORR) (PE)
Addition of Durvalumab plus Oleclumab to FOLFOX plus BEV (SoC) showed a moderate response increase without PFS benefit vs SoC alone. Safety was consistent with known safety profiles