Actively Recruiting
Study of Pembrolizumab Treatment After CYAD-101 With FOLFOX Preconditioning in Metastatic Colorectal Cancer
Led by Celyad Oncology SA · Updated on 2022-03-09
34
Participants Needed
5
Research Sites
861 weeks
Total Duration
On this page
Sponsors
C
Celyad Oncology SA
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of Pembrolizumab Treatment After CYAD-101 With FOLFOX Preconditioning in Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically proven metastatic adenocarcinoma of the colon or rectum
- Confirmed metastatic unresectable adenocarcinoma of the colon or rectum
- Confirmed non-microsatellite instability high (non-MSI-H)/mismatch-repair proficient (pMMR) tumor status
- Measurable disease by RECIST version 1.1
- Recurrent or progressing disease after at least one line of systemic therapy for metastatic disease including FOLFOX chemotherapy
- Patient scheduled to receive FOLFOX chemotherapy
- Neurotoxicity less than or equal to CTCAE Grade 1 from previous chemotherapy
- ECOG performance status 0 or 1
- Adequate organ, hepatic, renal, pulmonary, and cardiac functions
- Tumor biopsy at screening
You will not qualify if you...
- Use of any other investigational agent or device within 4 weeks before first study treatment
- Use of any anticancer agent within 4 weeks before first study treatment
- Use of filgrastim (G-CSF) or similar growth factors within 7 days before first study treatment
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or agents targeting other T-cell receptors
- Prior radiotherapy within 2 weeks before first study treatment
- Major surgery within 4 weeks before first study treatment
- Receipt of a live vaccine within 30 days before first study treatment
- Uncontrolled intercurrent illness or serious uncontrolled medical disorder
- History of non-infectious pneumonitis requiring steroids or current pneumonitis as assessed by chest imaging within 48 hours before first treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Mayo Clinic
Jacksonville, Florida, United States, 32224
Not Yet Recruiting
2
Moffit Cancer Center
Tampa, Florida, United States, 33612
Not Yet Recruiting
3
UZ Antwerpen
Edegem, Belgium, 2650
Actively Recruiting
4
UZ Gent
Ghent, Belgium, 9000
Not Yet Recruiting
5
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
Research Team
C
Celyad Oncology Medical Monitor, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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