Treatment for advanced colorectal cancer using CYAD-101 and pembrolizumab

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

This study is testing a new treatment combining CYAD-101 with chemotherapy and pembrolizumab to see if it helps people with advanced colorectal cancer who haven't had success with other treatments.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 34 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Celyad Oncology SA (industry)
• Drugs / interventions: chemotherapy, pembrolizumab
• Locations: 5 sites (Jacksonville, Florida and 4 other locations)
• Trial ID: NCT04991948 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of CYAD-101 in combination with FOLFOX chemotherapy, followed by pembrolizumab treatment in patients with unresectable metastatic colorectal cancer. The approach involves administering CYAD-101 concurrently with FOLFOX to assess its clinical activity, followed by pembrolizumab to enhance the treatment response. The study aims to provide insights into a potential new treatment option for patients who have not responded to previous therapies.

Who should consider this trial

Good fit: Ideal candidates include patients with unresectable metastatic colorectal cancer who have previously received FOLFOX chemotherapy and have measurable disease.

Not a fit: Patients with microsatellite instability high tumors or those who have received other investigational agents recently may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced colorectal cancer who have limited treatment choices.

How similar studies have performed: Other studies have shown promise with similar immunotherapy approaches, but this specific combination is novel.

Eligibility 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.

Where this trial is running

Jacksonville, Florida and 4 other locations

• Mayo Clinic — Jacksonville, Florida, United States (NOT_YET_RECRUITING)
• Moffit Cancer Center — Tampa, Florida, United States (NOT_YET_RECRUITING)
• UZ Antwerpen — Edegem, Belgium (RECRUITING)
• UZ Gent — Ghent, Belgium (NOT_YET_RECRUITING)
• UZ Leuven — Leuven, Belgium (RECRUITING)

Study contacts

• Study coordinator: Celyad Oncology Medical Monitor, MD, PhD

Conditions: Unresectable Metastatic Colorectal Cancer