Study of Pembrolizumab Treatment After CYAD-101 With FOLFOX Preconditioning in Metastatic Colorectal Cancer
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
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
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: CYAD-101 with FOLFOX Infusion administered concurrently followed by pembrolizumab
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Drug: CYAD-101
Allogeneic NKG2D-based CYAD-101 Chimeric antigen Receptor T-cells
Drug: FOLFOX
5-FU, leucovorin and oxaliplatin
Drug: Pembrolizumab
Humanized immunoglobulin G4 (IgG4) monoclonal antibody (mAb)
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Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Key Inclusion Criteria:
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Histologically proven metastatic adenocarcinoma of the colon or rectum.
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Confirmed metastatic unresectable adenocarcinoma of the colon or the rectum.
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Confirmed non-microsatellite instability high (non-MSI-H)/mismatch-repair proficient (pMMR) tumor status
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Unequivocal and measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).
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Recurrent/progressing disease after at least one line of systemic therapy for metastatic disease which must include FOLFOX chemotherapy
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The patient is due to receive FOLFOX chemotherapy
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Neurotoxicity less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 from previous chemotherapy.
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Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
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Adequate organ, hepatic, renal, pulmonary and cardiac functions
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Tumor biopsy at screening
Key Exclusion Criteria:
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Any other investigational agent or device within 4 weeks of the first study treatment administration.
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Any anticancer agent within 4 weeks of the first study treatment administration
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Filgrastim (Granulocyte-Colony-Stimulating Factor [G-CSF]) or similar growth factors within 7 days of the first study treatment administration
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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
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Prior radiotherapy within 2 weeks prior to the planned day for the first study treatment administration
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Major surgery within 4 weeks before the planned day for the first study treatment administration
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A live vaccine within 30 days prior to the planned day for the first study treatment administration
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Uncontrolled intercurrent illness or serious uncontrolled medical disorder
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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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Mayo Clinic | Jacksonville | Florida | United States | 32224 |
2 | Moffit Cancer Center | Tampa | Florida | United States | 33612 |
3 | UZ Antwerpen | Edegem | Belgium | 2650 | |
4 | UZ Gent | Ghent | Belgium | 9000 | |
5 | UZ Leuven | Leuven | Belgium | 3000 |
Sponsors and Collaborators
- Celyad Oncology SA
- Merck Sharp & Dohme LLC
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CYAD-101-002
- KEYNOTE-B79