Study of Pembrolizumab Treatment After CYAD-101 With FOLFOX Preconditioning in Metastatic Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT04991948|
Recruitment Status : Recruiting
First Posted : August 5, 2021
Last Update Posted : March 9, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Unresectable Metastatic Colorectal Cancer||Drug: CYAD-101 Drug: FOLFOX Drug: Pembrolizumab||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||34 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||November 22, 2021|
|Estimated Primary Completion Date :||August 21, 2023|
|Estimated Study Completion Date :||May 25, 2038|
|Experimental: CYAD-101 with FOLFOX Infusion administered concurrently followed by pembrolizumab||
Allogeneic NKG2D-based CYAD-101 Chimeric antigen Receptor T-cells
5-FU, leucovorin and oxaliplatin
Humanized immunoglobulin G4 (IgG4) monoclonal antibody (mAb)
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Key Inclusion Criteria:
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
Key Exclusion Criteria:
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04991948
|Contact: Celyad Oncology Medical Monitor, MD, PhDemail@example.com|
|United States, Florida|
|Mayo Clinic||Not yet recruiting|
|Jacksonville, Florida, United States, 32224|
|Contact: Jeremy Jones|
|Moffit Cancer Center||Not yet recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Kim Dae Won, MD|
|Principal Investigator: Kim Dae Won|
|Edegem, Belgium, 2650|
|Contact: Hans Prenen, MD|
|Principal Investigator: Hans Prenen, MD|
|UZ Gent||Not yet recruiting|
|Ghent, Belgium, 9000|
|Contact: Sylvie Rottey|
|Principal Investigator: Sylvie Rottey, MD|
|Leuven, Belgium, 3000|
|Contact: Hilde Marse|
|Principal Investigator: Eric Van Cutsem, MD|
|Responsible Party:||Celyad Oncology SA|
|Other Study ID Numbers:||
KEYNOTE-B79 ( Other Identifier: Celyad Oncology )
|First Posted:||August 5, 2021 Key Record Dates|
|Last Update Posted:||March 9, 2022|
|Last Verified:||February 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
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