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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04991948
Recruitment Status : Recruiting
First Posted : August 5, 2021
Last Update Posted : March 9, 2022
Sponsor:
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Celyad Oncology SA

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.

Condition or disease Intervention/treatment Phase
Unresectable Metastatic Colorectal Cancer Drug: CYAD-101 Drug: FOLFOX Drug: Pembrolizumab Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CYAD-101 with FOLFOX Infusion administered concurrently followed by pembrolizumab Drug: CYAD-101
Allogeneic NKG2D-based CYAD-101 Chimeric antigen Receptor T-cells

Drug: FOLFOX
5-FU, leucovorin and oxaliplatin

Drug: Pembrolizumab
Humanized immunoglobulin G4 (IgG4) monoclonal antibody (mAb)




Primary Outcome Measures :
  1. 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).

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Celyad Oncology Medical Monitor, MD, PhD +3210394100 clinicaltrials@celyad.com

Locations
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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         
Belgium
UZ Antwerpen Recruiting
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         
UZ Leuven Recruiting
Leuven, Belgium, 3000
Contact: Hilde Marse         
Principal Investigator: Eric Van Cutsem, MD         
Sponsors and Collaborators
Celyad Oncology SA
Merck Sharp & Dohme LLC
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Responsible Party: Celyad Oncology SA
ClinicalTrials.gov Identifier: NCT04991948    
Other Study ID Numbers: CYAD-101-002
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents