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

Phase 1

Recruiting

• Conditions: Unresectable Metastatic Colorectal Cancer
• Interventions: Drug: CYAD-101; Drug: FOLFOX; Drug: Pembrolizumab

• Registration Number: NCT04991948
• Lead Sponsor: Celyad Oncology SA

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

Study Timeline

• Study First Submitted: 2021-07-28
• Study First Submitted QC: 2021-07-28
• Study First Posted: 2021-08-05
• Study Start: 2021-11-22
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-22
• Last Update Posted: 2022-03-09
• Primary Completion: 2023-08-21
• Study Completion: 2038-05-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 34

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
CYAD-101 with FOLFOX Infusion administered concurrently followed by pembrolizumab	CYAD-101	-
CYAD-101 with FOLFOX Infusion administered concurrently followed by pembrolizumab	FOLFOX	-
CYAD-101 with FOLFOX Infusion administered concurrently followed by pembrolizumab	Pembrolizumab	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (5)

Mayo Clinic; 🇺🇸 Jacksonville, Florida, United States

UZ Antwerpen; 🇧🇪 Edegem, Belgium

UZ Gent; 🇧🇪 Ghent, Belgium

UZ Leuven; 🇧🇪 Leuven, Belgium

Moffit Cancer Center; 🇺🇸 Tampa, Florida, United States