Study of Petosemtamab Plus Chemotherapy Versus Cetuximab or Bevacizumab Plus Chemotherapy in RAS and BRAF Wild Type, Recurrent, Unresectable or Metastatic Colorectal Cancer (LiGeR-CRC2)

The purpose of this trial is to evaluate how well petosemtamab in combination with chemotherapy works against colorectal cancer that has recurred after previous treatment and that cannot be safely removed by surgery or has spread to other parts of the body. Participants will receive either petosemtamab + doctor's choice of chemotherapy (mFOLFOX6 or FOLFIRI) or doctor's choice of standard-of-care (SOC) cetuximab or bevacizumab + chemotherapy (mFOLFOX6 or FOLFIRI). No participants will be given placebo. The treatment duration will be different for every participant. If a participant's cancer s

Trial Details

NCT ID
NCT07775287
Phase
PHASE3
Sponsor
Genmab
Status
RECRUITING
Cancer Type
Colon Cancer Colorectal Cancer
Interventions
  • Petosemtamab
  • Cetuximab
  • Bevacizumab
  • 5-FU
  • Leucovorin (Calcium Folinate)
  • Oxaliplatin
Locations (sample)
  • Los Angeles, California, United States|34.05223,-118.24368
  • Savannah, Georgia, United States|32.08354,-81.09983
  • Olympia, Washington, United States|47.04491,-122.90169
  • Manati, Puerto Rico|18.42745,-66.49212

Key Eligibility Criteria

  • Histologically or cytologically confirmed colorectal adenocarcinoma that is recurrent, unresectable or metastatic.
  • Must have documented KRAS and NRAS wt CRC, as determined by medical record of results from local testing or as assessed by central testing. Next-ge…
  • Has received no more than 1 line of prior systemic therapy for unresectable or metastatic CRC, with documented disease progression. First line (1L)…
  • Must be eligible for treatment with mFOLFOX6 (if assigned by the investigator to receive mFOLFOX6) or FOLFIRI (if assigned by the investigator to r…

For full eligibility, visit ClinicalTrials.gov.

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