Treatment for advanced colorectal cancer using CYAD-101 and pembrolizumab

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and effectiveness of CYAD-101 in combination with FOLFOX chemotherapy, followed by pembrolizumab treatment in patients with unresectable metastatic colorectal cancer. The approach involves administering CYAD-101 concurrently with FOLFOX to assess its clinical activity, followed by pembrolizumab to enhance the treatment response. The study aims to provide insights into a potential new treatment option for patients who have not responded to previous therapies.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

1. Histologically proven metastatic adenocarcinoma of the colon or rectum.

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

Key Exclusion Criteria:

1. Any other investigational agent or device within 4 weeks of the first study treatment administration.
2. Any anticancer agent within 4 weeks of the first study treatment administration
3. Filgrastim (Granulocyte-Colony-Stimulating Factor \[G-CSF\]) or similar growth factors within 7 days of the first study treatment administration
4. 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
5. Prior radiotherapy within 2 weeks prior to the planned day for the first study treatment administration
6. Major surgery within 4 weeks before the planned day for the first study treatment administration
7. A live vaccine within 30 days prior to the planned day for the first study treatment administration
8. Uncontrolled intercurrent illness or serious uncontrolled medical disorder
9. 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.

Where it's running

• UZ Antwerpen
  Edegem, Belgium Recruiting
• UZ Leuven
  Leuven, Belgium Recruiting
• Mayo Clinic
  Jacksonville, Florida, United States Not yet recruiting
• Moffit Cancer Center
  Tampa, Florida, United States Not yet recruiting
• UZ Gent
  Ghent, Belgium Not yet recruiting

Study contacts

• Study coordinator: Celyad Oncology Medical Monitor, MD, PhD
• Email: clinicaltrials@celyad.com
• Phone: +3210394100

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.