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| ID | Type | Description | Link |
|---|---|---|---|
| KEYNOTE-B79 | Other Identifier | Celyad Oncology |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CYAD-101 with FOLFOX Infusion administered concurrently followed by pembrolizumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CYAD-101 | Drug | Allogeneic NKG2D-based CYAD-101 Chimeric antigen Receptor T-cells |
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| Measure | Description | Time Frame |
|---|---|---|
| The Occurrence of Dose Limiting Toxicities (DLT) during the 'DLT reporting period' | 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). | Up to 73 days post first study treatment administration |
| The objective response rate (ORR) at the tumor assessment on Day 94 [Visit 15]) | The objective response rate (ORR) at the tumor assessment on Day 94 [Visit 15]), 6 weeks after the first pembrolizumab treatment administration. | Up to 94 days post first study treatment administration |
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Key Inclusion Criteria:
Histologically proven metastatic adenocarcinoma of the colon or rectum.
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Adequate organ, hepatic, renal, pulmonary and cardiac functions
Tumor biopsy at screening
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Celyad Oncology Medical Monitor, MD, PhD | Contact | +3210394100 | clinicaltrials@celyad.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Not yet recruiting | Jacksonville | Florida | 32224 | United States |
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| FOLFOX | Drug | 5-FU, leucovorin and oxaliplatin |
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| Pembrolizumab | Drug | Humanized immunoglobulin G4 (IgG4) monoclonal antibody (mAb) |
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| Moffit Cancer Center | Not yet recruiting | Tampa | Florida | 33612 | United States |
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| UZ Antwerpen | Recruiting | Edegem | 2650 | Belgium |
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| UZ Gent | Not yet recruiting | Ghent | 9000 | Belgium |
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| UZ Leuven | Recruiting | Leuven | 3000 | Belgium |
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| ID | Term |
|---|---|
| C410216 | Folfox protocol |
| C582435 | pembrolizumab |
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