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

Description

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.

Conditions

Unresectable Metastatic Colorectal Cancer

Study Overview

Study Details

Study overview

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.

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

Condition
Unresectable Metastatic Colorectal Cancer
Intervention / Treatment

-

Contacts and Locations

Jacksonville

Mayo Clinic, Jacksonville, Florida, United States, 32224

Tampa

Moffit Cancer Center, Tampa, Florida, United States, 33612

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Celyad Oncology SA,

Study Record Dates

2038-05-25