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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

About this trial

This is an interventional treatment trial for Unresectable Metastatic Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

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.
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

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

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

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

Learn more about this trial

Study of Pembrolizumab Treatment After CYAD-101 With FOLFOX Preconditioning in Metastatic Colorectal Cancer

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