Clinical Trial

ROSETTA CRC-203: A Blinded, Randomized Phase 2/3 Study of Pumitamig in Combination with Chemotherapy Versus Bevacizumab in Combination with Chemotherapy in Participants with Previously Untreated, Unresectable, or Metastatic Colorectal Cancer – CA266-0003

MOA: Pumitamig (BMS-986545/BNT327) is a bispecific antibody targeting PD-L1 and VEG-F.

Key Eligibility Criteria:

• Previously untreated, histologically confirmed recurrent or metastatic colorectal adenocarcinoma, not amenable to curative surgery
• MSI-H/dMMR and BRAF V600E excluded per local testing​
• KRAS and NRAS mutation status must have been documented prior to randomization in Phase 2
• Adjuvant or neoadjuvant chemotherapy must be completed (>6 months) before diagnosis of recurrent or metastatic disease
• Subjects are excluded that have received prior systemic treatment specifically targeting T cell co-stimulation or checkpoint pathways: an anti-PD-1, anti-PD-L1/2, CD137 agonists​ or an anti-CTLA-4 antibody