Study of Pembrolizumab Treatment After CYAD-101 With FOLFOX Preconditioning in Metastatic Colorectal Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCelyad Oncology SA
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically proven metastatic adenocarcinoma of the colon or rectum.
Confirmed metastatic unresectable adenocarcinoma of the colon or the rectum.
Confirmed non-microsatellite instability high (non-MSI-H)/mismatch-repair proficient (pMMR) tumor status
Unequivocal and measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).
Disqualifiers
Any other investigational agent or device within 4 weeks of the first study treatment administration.
Any anticancer agent within 4 weeks of the first study treatment administration
Filgrastim (Granulocyte-Colony-Stimulating Factor [G-CSF]) or similar growth factors within 7 days of the first study treatment administration
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
Trial design
Design model
Sequential
Treatments tested in this trial
CYAD-101
DrugAllogeneic NKG2D-based CYAD-101 Chimeric antigen Receptor T-cells
FOLFOX
Drug5-FU, leucovorin and oxaliplatin
Pembrolizumab
DrugHumanized immunoglobulin G4 (IgG4) monoclonal antibody (mAb)
Treatment groups
34 Participants
are divided into 1 treatment groupGroup A: CYAD-101 with FOLFOX Infusion administered concurrently followed by pembrolizumabExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
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).
Time frame
Up to 73 days post first study treatment administration2
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.
Time frame
Up to 94 days post first study treatment administrationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Celyad Oncology SA
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
Source ClinicalTrials.gov