Study of Pembrolizumab Treatment After CYAD-101 With FOLFOX Preconditioning in Metastatic Colorectal Cancer
Primary Purpose
Unresectable Metastatic Colorectal Cancer
Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
CYAD-101
FOLFOX
Pembrolizumab
Sponsored by
About this trial
This is an interventional treatment trial for Unresectable Metastatic Colorectal Cancer
Eligibility Criteria
Key Inclusion Criteria:
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).
- Recurrent/progressing disease after at least one line of systemic therapy for metastatic disease which must include FOLFOX chemotherapy
- The patient is due to receive FOLFOX chemotherapy
- Neurotoxicity less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 from previous chemotherapy.
- 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:
- 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
- Prior radiotherapy within 2 weeks prior to the planned day for the first study treatment administration
- Major surgery within 4 weeks before the planned day for the first study treatment administration
- A live vaccine within 30 days prior to the planned day for the first study treatment administration
- Uncontrolled intercurrent illness or serious uncontrolled medical disorder
- 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.
Sites / Locations
- Mayo Clinic
- Moffit Cancer Center
- UZ AntwerpenRecruiting
- UZ Gent
- UZ LeuvenRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CYAD-101 with FOLFOX Infusion administered concurrently followed by pembrolizumab
Arm Description
Outcomes
Primary Outcome Measures
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).
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04991948
First Posted
July 28, 2021
Last Updated
February 22, 2022
Sponsor
Celyad Oncology SA
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT04991948
Brief Title
Study of Pembrolizumab Treatment After CYAD-101 With FOLFOX Preconditioning in Metastatic Colorectal Cancer
Official Title
An Open-label, Phase Ib Study to Assess the Safety and Clinical Activity of CYAD-101 Administered Concurrently With FOLFOX Chemotherapy, Followed by Pembrolizumab Treatment, in Patients With Metastatic Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 22, 2021 (Actual)
Primary Completion Date
August 21, 2023 (Anticipated)
Study Completion Date
May 25, 2038 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celyad Oncology SA
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unresectable Metastatic Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CYAD-101 with FOLFOX Infusion administered concurrently followed by pembrolizumab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
CYAD-101
Intervention Description
Allogeneic NKG2D-based CYAD-101 Chimeric antigen Receptor T-cells
Intervention Type
Drug
Intervention Name(s)
FOLFOX
Intervention Description
5-FU, leucovorin and oxaliplatin
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Intervention Description
Humanized immunoglobulin G4 (IgG4) monoclonal antibody (mAb)
Primary Outcome Measure Information:
Title
The Occurrence of Dose Limiting Toxicities (DLT) during the 'DLT reporting period'
Description
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 administration
Title
The objective response rate (ORR) at the tumor assessment on Day 94 [Visit 15])
Description
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 administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
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).
Recurrent/progressing disease after at least one line of systemic therapy for metastatic disease which must include FOLFOX chemotherapy
The patient is due to receive FOLFOX chemotherapy
Neurotoxicity less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 from previous chemotherapy.
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:
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
Prior radiotherapy within 2 weeks prior to the planned day for the first study treatment administration
Major surgery within 4 weeks before the planned day for the first study treatment administration
A live vaccine within 30 days prior to the planned day for the first study treatment administration
Uncontrolled intercurrent illness or serious uncontrolled medical disorder
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Celyad Oncology Medical Monitor, MD, PhD
Phone
+3210394100
Email
clinicaltrials@celyad.com
Facility Information:
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeremy Jones
Facility Name
Moffit Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kim Dae Won, MD
First Name & Middle Initial & Last Name & Degree
Kim Dae Won
Facility Name
UZ Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hans Prenen, MD
First Name & Middle Initial & Last Name & Degree
Hans Prenen, MD
Facility Name
UZ Gent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvie Rottey
First Name & Middle Initial & Last Name & Degree
Sylvie Rottey, MD
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hilde Marse
First Name & Middle Initial & Last Name & Degree
Eric Van Cutsem, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of Pembrolizumab Treatment After CYAD-101 With FOLFOX Preconditioning in Metastatic Colorectal Cancer
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