Unresectable Metastatic Colorectal CancerPhase 1NCT04991948
Study of Pembrolizumab Treatment After CYAD-101 With FOLFOX Preconditioning in Metastatic Colorectal Cancer
A Phase 1 study testing CYAD-101, FOLFOX and Pembrolizumab in people with Unresectable Metastatic Colorectal Cancer, run by Celyad Oncology SA at 5 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable Metastatic Colorectal Cancer
- What is being tested?
- CYAD-101, FOLFOX and Pembrolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 22 Nov 2021to 25 May 2038
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 2 countries
Belgium3 sites, 3 recruiting
- Recruiting
UZ Antwerpen
Edegem, 2650
Hans Prenen, MD
Hans Prenen, MD
- Not yet recruiting
UZ Gent
Ghent, 9000
Sylvie Rottey
Sylvie Rottey, MD
- Recruiting
UZ Leuven
Leuven, 3000
Hilde Marse
Eric Van Cutsem, MD
United States2 sites, 2 recruiting
- Not yet recruiting
Mayo Clinic
Jacksonville, Florida, 32224
Jeremy Jones
- Not yet recruiting
Moffit Cancer Center
Tampa, Florida, 33612
Kim Dae Won, MD
Kim Dae Won
About this study
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
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.
Read the 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
- Being tested
- CYAD-101, FOLFOX, Pembrolizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CYAD-101Drug
Allogeneic NKG2D-based CYAD-101 Chimeric antigen Receptor T-cells
FOLFOXDrug
5-FU, leucovorin and oxaliplatin
PembrolizumabDrug
Humanized immunoglobulin G4 (IgG4) monoclonal antibody (mAb)
| Study group | Role | What they receive |
|---|---|---|
| CYAD-101 with FOLFOX Infusion administered concurrently followed by pembrolizumab | Experimental | Not described Receives: Drug: CYAD-101; Drug: FOLFOX; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Up to 94 days post first study treatment administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start22 Nov 2021
- Primary completion21 Aug 2023 (estimated)
- Study completion25 May 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable Metastatic Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Celyad Oncology SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04991948
- Sponsor's protocol ID
- CYAD-101-002
- Other IDs
- KEYNOTE-B79
- Status last verified
- Feb 2022
- First submitted
- 28 Jul 2021
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04991948
- Acronym / sponsor ID
- CYAD-101-002
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Celyad Oncology SAIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 22 Nov 2021 (actual)
- Primary completion
- 21 Aug 2023 (estimated)
- Study completion
- 25 May 2038 (estimated)
- First posted
- 5 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CYAD-101 with FOLFOX Infusion administered concurrently followed by pembrolizumab | Experimental | Drug: CYAD-101, Drug: FOLFOX, Drug: Pembrolizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically proven metastatic adenocarcinoma of the colon or rectum.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Adequate organ, hepatic, renal, pulmonary and cardiac functions
- Tumor biopsy at screening
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CYAD-101Allogeneic NKG2D-based CYAD-101 Chimeric antigen Receptor T-cells | Drug | CYAD-101 with FOLFOX Infusion administered concurrently followed by pembrolizumab |
| FOLFOX5-FU, leucovorin and oxaliplatin | Drug | CYAD-101 with FOLFOX Infusion administered concurrently followed by pembrolizumab |
| PembrolizumabHumanized immunoglobulin G4 (IgG4) monoclonal antibody (mAb) | Drug | CYAD-101 with FOLFOX Infusion administered concurrently followed by pembrolizumab |
Primary outcome
The Occurrence of Dose Limiting Toxicities (DLT) during the 'DLT reporting period'
Time frame: Up to 73 days post first study treatment administration
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).
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
The objective response rate (ORR) at the tumor assessment on Day 94 [Visit 15]), 6 weeks after the first pembrolizumab treatment administration.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CYAD-101, FOLFOX and Pembrolizumab in people with Unresectable Metastatic Colorectal Cancer, run by Celyad Oncology SA at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Celyad Oncology Medical Monitor, MD, PhD (+3210394100, clinicaltrials@celyad.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Occurrence of Dose Limiting Toxicities (DLT) during the 'DLT reporting period' (time frame: Up to 73 days post first study treatment administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2022.