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NCT04991948

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

Recruiting · Phase 1 · Celyad Oncology SA · registry updated 2022-03-09

Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.

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.

Inclusion

  • 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

Exclusion

  • 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

Open NCT04991948 on ClinicalTrials.govAll conditions