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)
Start Date
10/15/2026
Completion Date
1/31/2030
Summary
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 stays the same or gets better, and there are not any serious problems, participants can keep getting study treatment for as long as the study is open. Participants will be asked to attend 2 visits at the study clinic for each cycle (duration of cycle is 4 weeks). During visits, there will be various tests (such as blood draws) and procedures (such as imaging) to monitor whether the study treatment is safe and effective. The overall study duration (including screening, treatment, and follow-up) will be different for every participant.
Detailed Description
This is a Phase 3, randomized, open-label, global, multicenter, interventional trial to evaluate the efficacy and safety of petosemtamab in combination with investigator's choice (IC) chemotherapy (fluorouracil + leucovorin \[calcium folinate\] + irinotecan \[FOLFIRI\] or 5-FU, leucovorin \[calcium folinate\], and oxaliplatin \[mFOLFOX6\]; Arm A) versus IC cetuximab or bevacizumab in combination with IC chemotherapy (FOLFIRI or mFOLFOX6; Arm B) as second line (2L) treatment for participants with KRAS, NRAS, and BRAF wild type (wt), recurrent, unresectable or metastatic colorectal cancer (CRC).
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Petosemtamab
Cetuximab
Bevacizumab
5-FU
Leucovorin (Calcium Folinate)
Oxaliplatin
Irinotecan
Conditions
Locations
Valkyrie Clinical Trials - Los Angeles
Los Angeles, California 90067
United States
Low Country Cancer Care Associates_Savannah_2
Savannah, Georgia 31404
United States
Vista Oncology - West Olympia_Olympia_2
Olympia, Washington 98502
United States
PanOncology
Manati, 00674
Puerto Rico