NCT04991948RecruitingPhase 1
Study of Pembrolizumab Treatment After CYAD-101 With FOLFOX Preconditioning in Metastatic Colorectal Cancer
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
Source: ClinicalTrials.gov · Last updated 9 Mar 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 34 (estimated)
- First submitted
- 28 Jul 2021
- Start date
- 22 Nov 2021
- Primary completion date
- 21 Aug 2023
- Lead sponsor
- Celyad Oncology SA
- Diseases
- Colorectal cancer
- NCT number
- NCT04991948
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 34
- From 22 Nov 2021 to the primary completion date, 21 Aug 2023
- 5 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any other investigational agent or device within 4 weeks 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
- 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.
Other illness
- Uncontrolled intercurrent illness or serious uncontrolled medical disorder
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UZ Antwerpen Coordinator of this site? Confirm its status | Edegem | Belgium | Recruiting |
| UZ Gent Coordinator of this site? Confirm its status | Ghent | Belgium | Not yet recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| Mayo Clinic Coordinator of this site? Confirm its status | Jacksonville | United States | Not yet recruiting |
| Moffit Cancer Center Coordinator of this site? Confirm its status | Tampa | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.