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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Unresectable Metastatic Colorectal Cancer
• Intervention / Treatment: Drug: CYAD-101; Drug: FOLFOX; Drug: Pembrolizumab

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 Type: Interventional
• Enrollment (Anticipated): 34
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Edegem, Belgium, 2650
    • Recruiting
    • UZ Antwerpen
  • Ghent, Belgium, 9000
    • Not yet recruiting
    • UZ Gent
    • Principal Investigator: Sylvie Rottey, MD
    • Contact: Sylvie Rottey
  • Leuven, Belgium, 3000
    • Recruiting
    • UZ Leuven
• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Not yet recruiting
      • Mayo Clinic
      • Contact: Jeremy Jones
    • Tampa, Florida, United States, 33612
      • Not yet recruiting
      • Moffit Cancer center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CYAD-101 with FOLFOX Infusion administered concurrently followed by pembrolizumab	Drug: CYAD-101; Allogeneic NKG2D-based CYAD-101 Chimeric antigen Receptor T-cells; Drug: FOLFOX; 5-FU, leucovorin and oxaliplatin; Drug: Pembrolizumab; Humanized immunoglobulin G4 (IgG4) monoclonal antibody (mAb)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Celyad Oncology SA
• Collaborators: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2021
• Primary Completion (Anticipated): August 21, 2023
• Study Completion (Anticipated): May 25, 2038

Study Registration Dates

• First Submitted: July 28, 2021
• First Submitted That Met QC Criteria: July 28, 2021
• First Posted (Actual): August 5, 2021

Study Record Updates

• Last Update Posted (Actual): March 9, 2022
• Last Update Submitted That Met QC Criteria: February 22, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Antineoplastic Agents; Antineoplastic Agents, Immunological; Pembrolizumab
• Other Study ID Numbers: CYAD-101-002; KEYNOTE-B79 (Other Identifier: Celyad Oncology)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No