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Recruiting NCT04991948

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

Phase I Interventional Unresectable Metastatic Colorectal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CYAD-101, FOLFOX, Pembrolizumab.
Who it may be relevant to
Registry conditions: Unresectable Metastatic Colorectal Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

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.

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

Interventions

  • 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)

Primary outcome measures

  • The Occurrence of Dose Limiting Toxicities (DLT) during the 'DLT reporting period' [Time frame: Up to 73 days post first study treatment administration]
  • The objective response rate (ORR) at the tumor assessment on Day 94 [Visit 15]) [Time frame: Up to 94 days post first study treatment administration]

Eligibility criteria

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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Belgium · 3 centers
  • UZ Antwerpen — Edegem
  • UZ Gent — Ghent
  • UZ Leuven — Leuven
United States · 2 centers
  • Mayo Clinic — Jacksonville
  • Moffit Cancer Center — Tampa

Identifiers

NCT: NCT04991948 · CYAD-101-002 · KEYNOTE-B79

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗