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

NCT04991948 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: CYAD-101-002KEYNOTE-B79
• Study Type: interventional
• Target: 34
• Locations: 2 countries
• Sites: 5

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.

Conditions

Unresectable Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

CYAD-101 with FOLFOX Infusion administered concurrently followed by pembrolizumab

EXPERIMENTAL

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

Interventions

CYAD-101 DRUG

Allogeneic NKG2D-based CYAD-101 Chimeric antigen Receptor T-cells

CYAD-101 with FOLFOX Infusion administered concurrently followed by pembrolizumab

FOLFOX DRUG

5-FU, leucovorin and oxaliplatin

CYAD-101 with FOLFOX Infusion administered concurrently followed by pembrolizumab

Pembrolizumab DRUG

Humanized immunoglobulin G4 (IgG4) monoclonal antibody (mAb)

CYAD-101 with FOLFOX Infusion administered concurrently followed by pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celyad Oncology SA: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (5)

Mayo Clinic

Jacksonville, Florida, 32224, United States

NOT YET RECRUITING

Moffit Cancer Center

Tampa, Florida, 33612, United States

NOT YET RECRUITING

UZ Antwerpen

Edegem, 2650, Belgium

RECRUITING

UZ Gent

Ghent, 9000, Belgium

NOT YET RECRUITING

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

MeSH Terms

Interventions

Folfox protocol; pembrolizumab

Central Study Contacts

Celyad Oncology Medical Monitor, MD, PhD

CONTACT

+3210394100; clinicaltrials@celyad.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: August 5, 2021
• Study Start: November 22, 2021
• Primary Completion: August 21, 2023
• Study Completion (Estimated): May 25, 2038
• Last Updated: March 9, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (3); US (2)