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

Unresectable Metastatic Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04991948
• Other study ID #: CYAD-101-002
• Secondary ID: KEYNOTE-B79
• Status: Recruiting
• Phase: Phase 1
• Start date: November 22, 2021
• Est. completion date: May 25, 2038

Study information

• Verified date: February 2022
• Source: Celyad Oncology SA
• Contact: Celyad Oncology Medical Monitor, MD, PhD
• Phone: +3210394100
• Email: clinicaltrials[@]celyad.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: May 25, 2038
• Est. primary completion date: August 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

1. 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.

2. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

3. Adequate organ, hepatic, renal, pulmonary and cardiac functions

4. Tumor biopsy at screening

Key Exclusion Criteria:

1. Any other investigational agent or device within 4 weeks of the first study treatment administration.

2. Any anticancer agent within 4 weeks of the first study treatment administration

3. Filgrastim (Granulocyte-Colony-Stimulating Factor [G-CSF]) or similar growth factors within 7 days of the first study treatment administration

4. 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

5. Prior radiotherapy within 2 weeks prior to the planned day for the first study treatment administration

6. Major surgery within 4 weeks before the planned day for the first study treatment administration

7. A live vaccine within 30 days prior to the planned day for the first study treatment administration

8. Uncontrolled intercurrent illness or serious uncontrolled medical disorder

9. 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.

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Unresectable Metastatic Colorectal Cancer

Intervention

Drug:
• CYAD-101
Allogeneic NKG2D-based CYAD-101 Chimeric antigen Receptor T-cells
• FOLFOX
5-FU, leucovorin and oxaliplatin
• Pembrolizumab
Humanized immunoglobulin G4 (IgG4) monoclonal antibody (mAb)

Locations

Country	Name	City	State
Belgium	UZ Antwerpen	Edegem
Belgium	UZ Gent	Ghent
Belgium	UZ Leuven	Leuven
United States	Mayo Clinic	Jacksonville	Florida
United States	Moffit Cancer Center	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Celyad Oncology SA	Merck Sharp & Dohme Corp.

Countries where clinical trial is conducted

United States,  Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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