The purpose of this trial is to evaluate how well petosemtamab in combination with chemotherapy works against colorectal cancer located on the left side of the colon 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 standard-of-care cetuximab + doctor's choice of 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.
This Phase 3, randomized, open-label, global trial is designed to assess the efficacy and safety of petosemtamab plus investigator's choice (IC) chemotherapy (fluorouracil + leucovorin (calcium folinate) + oxaliplatin \[mFOLFOX6\] or fluorouracil + leucovorin (calcium folinate) + irinotecan \[FOLFIRI\]) versus standard of care (SOC) (ie, cetuximab + IC chemotherapy \[mFOLFOX6 or FOLFIRI\]) as 1L therapy in participants with unresectable or metastatic left-sided colorectal cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
960
Intravenous infusion
Intravenous infusion
Fluorouracil + leucovorin (calcium folinate) + irinotecan via intravenous infusion.
Fluorouracil + leucovorin (calcium folinate) + oxaliplatin via intravenous infusion.
Low Country Cancer Care Associates_Savannah_1
Savannah, Georgia, United States
RECRUITINGCentral Georgia Cancer Care - Warner Robins Office
Warner Robins, Georgia, United States
RECRUITINGHematology-Oncology of Indiana, P.C.
Indianapolis, Indiana, United States
RECRUITINGOncology Hematology Associates - Springfield_Springfield_2
Springfield, Missouri, United States
RECRUITINGVista Oncology
Olympia, Washington, United States
RECRUITINGPanOncology
Manati, PR, Puerto Rico
RECRUITINGProgression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as Assessed by Blinded Independent Central Review (BICR)
Time frame: Up to approximately 35 months
Objective Response Rate (ORR) per RECIST v1.1 as Assessed by BICR
Time frame: Up to approximately 35 months
Overall Survival (OS)
Time frame: Up to approximately 62 months
Duration of Response (DOR) per RECIST v1.1 as Assessed by BICR
Time frame: Up to approximately 62 months
Disease Control Rate (DCR) per RECIST v1.1 as Assessed by BICR
Time frame: Up to approximately 62 months
Progression-free Survival after First Subsequent Therapy (PFS2)
Time frame: Up to approximately 62 months
Curative Resection (R0) Rate
Time frame: Up to approximately 62 months
Number of Participants with Adverse Events (AEs)
Time frame: Up to approximately 62 months
Change from Baseline in Symptoms and Functioning, as Measured by European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-life Questionnaire (QLQ)-F17
Time frame: Baseline up to approximately 62 months
Change from Baseline in Symptoms and Functioning, as Measured by EORTC QLQ-CR29
Time frame: Baseline up to approximately 62 months
Time to Worsening in Symptoms and Functioning, as Measured by EORTC QLQ-F17
Time frame: Up to approximately 62 months
Time to Worsening in Symptoms and Functioning, as Measured by EORTC QLQ-CR29
Time frame: Up to approximately 62 months
Overall Side Effect Burden, as Measured by EORTC Item 168
Time frame: Up to approximately 62 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.