Study of Pembrolizumab Treatment After CYAD-101 With FOLFOX Preconditioning in Metastatic Colorectal Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCelyad Oncology SA
About this trial
The purpose of the CYAD-101-002 study is to assess the safety and clinical activity of CYAD-101 in patients with unresectable metastatic colorectal cancer administered concurrently with FOLFOX chemotherapy, followed by pembrolizumab treatment.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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
Trial design
Treatments tested in this trial
- CYAD-101
- FOLFOX
- Pembrolizumab
Treatment groups
34 Participants
are divided into 1 treatment groupSponsors and collaborators
Celyad Oncology SA
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
Source ClinicalTrials.gov