No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
34 (estimated)
Sponsor
Celyad Oncology SA · Industry
Who this trial is looking for
This trial is looking for patients with advanced colorectal cancer that can't be surgically removed. Participants will receive a specific treatment that includes CYAD-101 and FOLFOX chemotherapy, followed by pembrolizumab.
Are You a Good Fit for This Trial?
Must be takingFOLFOX chemotherapy
Rules you outPneumonitis
You may be able to join if
I have been diagnosed with metastatic colorectal cancer.
I am about to start FOLFOX chemotherapy.
I have measurable disease that can be seen on imaging.
I have had disease that got worse after at least one previous treatment.
I have a good performance status (0 or 1).
I have adequate organ functions.
I have had a tumor biopsy recently.
You may not be able to join if
I have taken any other experimental treatment in the last 4 weeks.
I have taken any anticancer drug in the last 4 weeks.
I have taken growth factors like filgrastim in the last 7 days.
I have received therapy with anti-PD-1 or similar agents before.
I have had radiation therapy in the last 2 weeks.
I have had major surgery in the last 4 weeks.
I have received a live vaccine in the last 30 days.
I have an uncontrolled medical condition.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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City
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Status
Eligibility Criteria
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.…
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.
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