Study of Pembrolizumab Treatment After CYAD-101 With FOLFOX Preconditioning in Metastatic Colorectal Cancer

This Study aims to provide insight into whether CYAD-101 administration concurrently with FOLFOX chemotherapy, followed by pembrolizumab treatment might be a treatment option for patients with unresectable metastatic colorectal cancer

Key Inclusion Criteria:

• Histologically proven metastatic adenocarcinoma of the colon or rectum.

• Confirmed metastatic unresectable adenocarcinoma of the colon or the rectum.
• Confirmed non-microsatellite instability high (non-MSI-H)/mismatch-repair proficient (pMMR) tumor status
• Unequivocal and measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).
• Recurrent/progressing disease after at least one line of systemic therapy for metastatic disease which must include FOLFOX chemotherapy
• The patient is due to receive FOLFOX chemotherapy
• Neurotoxicity less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 from previous chemotherapy.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• Adequate organ, hepatic, renal, pulmonary and cardiac functions
• Tumor biopsy at screening

Key Exclusion Criteria:

• Any other investigational agent or device within 4 weeks of the first study treatment administration.
• Any anticancer agent within 4 weeks of the first study treatment administration
• Filgrastim (Granulocyte-Colony-Stimulating Factor [G-CSF]) or similar growth factors within 7 days of the first study treatment administration
• Prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor
• Prior radiotherapy within 2 weeks prior to the planned day for the first study treatment administration
• Major surgery within 4 weeks before the planned day for the first study treatment administration
• A live vaccine within 30 days prior to the planned day for the first study treatment administration
• Uncontrolled intercurrent illness or serious uncontrolled medical disorder
• Patients with history of (non-infectious) pneumonitis that require steroids or has current pneumonitis as assessed by chest imaging within 48 hours prior to first study treatment administration.