To learn if SAR445877 in combination with FOLFOX6 and bevacizumab can be safely given to patients with advanced MSS CRC.
Ability to understand and willingness to sign informed consent form prior to initiation of the study and any study procedures.
Capable of and willing to comply with scheduled visits, treatment plans, laboratory tests, and other study-related tests and procedures.
Age ≥18 years.
Participants with histologically documented CRC with metastatic disease who have not received prior treatment in the metastatic setting. Participants who have received adjuvant FOLFOX must be 6 months from treatment at the time of enrollment.
Pregnant or breastfeeding.
Ongoing or recent (within 2 years) evidence of significant autoimmune disease that requires/required treatment with systemic immunosuppressive treatments, which may suggest risk for irAEs. Participants with the following conditions are eligible: vitiligo, childhood asthma that has resolved, residual hypothyroidism that required only hormone replacement or psoriasis that does not require systemic treatment.
Participants who are receiving any other investigational agents.
Receipt of a live-virus vaccination within 28 days prior to study treatment initiation. Non-live COVID vaccines will be allowed on study, but it is recommended to avoid their use during the first treatment cycle (from 3 days prior to Cycle 1 Day 1 through Cycle 2 Day 3).
Single group
SAR445877
DrugGiven by IV
FOLFOX6
DrugGiven by IV
Bevacizumab
DrugGiven by IV
Safety and adverse events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Click on the lead sponsor to view all of their trials.
M.D. Anderson Cancer Center
Lead sponsor
Sanofi
Collaborator
