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

Celyad Oncology

Status and phase: Enrolling; Phase 1

Conditions: Unresectable Metastatic Colorectal Cancer

Treatments: Drug: CYAD-101; Drug: FOLFOX; Drug: Pembrolizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04991948

CYAD-101-002

KEYNOTE-B79 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 34 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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34 participants in 1 patient group

CYAD-101 with FOLFOX Infusion administered concurrently followed by pembrolizumab

Experimental group

Treatment:

Drug: CYAD-101

Drug: FOLFOX

Drug: Pembrolizumab