Unresectable Metastatic Colorectal Cancer
Conditions
Brief 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.
Detailed description
This Study aims to provide insight into whether CYAD-101 administration concurrently with FOLFOX chemotherapy, followed by pembrolizumab treatment might be a treatment option for patients with unresectable metastatic colorectal cancer
Interventions
DRUGCYAD-101
Allogeneic NKG2D-based CYAD-101 Chimeric antigen Receptor T-cells
DRUGFOLFOX
5-FU, leucovorin and oxaliplatin
DRUGPembrolizumab
Humanized immunoglobulin G4 (IgG4) monoclonal antibody (mAb)
Sponsors
Merck Sharp & Dohme LLC
Celyad Oncology SA
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Occurrence of Dose Limiting Toxicities (DLT) during the 'DLT reporting period' | Up to 73 days post first study treatment administration | The occurrence of DLT during the 'DLT reporting period' is defined as the period from study enrollment on D1 (Visit 1) up to 3 weeks after first pembrolizumab treatment on D73 (Visit 14). |
| The objective response rate (ORR) at the tumor assessment on Day 94 [Visit 15]) | Up to 94 days post first study treatment administration | The objective response rate (ORR) at the tumor assessment on Day 94 \[Visit 15\]), 6 weeks after the first pembrolizumab treatment administration. |
Countries
Belgium, United States
Contacts
Primary ContactCelyad Oncology Medical Monitor, MD, PhD
Outcome results
None listed