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Clinical Trials in Belgium / NCT04991948
Recruiting Phase 1

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

NCT04991948 · tracked via the Priya Life Science Belgium tracker
Phase
Phase 1
Started
2021-11-22
Last updated
2022-03-09

Condition(s) studied

Unresectable Metastatic Colorectal Cancer

Investigational drug(s) / intervention(s)

CYAD-101 →FOLFOX →Pembrolizumab →

CYAD-101: Allogeneic NKG2D-based CYAD-101 Chimeric antigen Receptor T-cells

FOLFOX: 5-FU, leucovorin and oxaliplatin

Pembrolizumab: Humanized immunoglobulin G4 (IgG4) monoclonal antibody (mAb)

Study summary

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
Mayo Clinic Jacksonville Florida Not Yet Recruiting
Moffit Cancer Center Tampa Florida Not Yet Recruiting
UZ Antwerpen Edegem Belgium Recruiting
UZ Gent Ghent Belgium Not Yet Recruiting
UZ Leuven Leuven Belgium Recruiting

On this site

📄 Keytruda (pembrolizumab) drug profile →

More Celyad Oncology SA trials in Belgium

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04991948 on ClinicalTrials.gov ↗ ← All trials in Belgium