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

Sponsor
Celyad Oncology SA (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04991948
Collaborator
Merck Sharp & Dohme LLC (Industry)
34
5
1
198
6.8
0

Study Details

Study Description

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
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

Study Design

Study Type:
Interventional
Anticipated 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 :
Nov 22, 2021
Anticipated Primary Completion Date :
Aug 21, 2023
Anticipated Study Completion Date :
May 25, 2038

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. The Occurrence of Dose Limiting Toxicities (DLT) during the 'DLT reporting period' [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]) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Key Inclusion Criteria:
  1. Histologically proven metastatic adenocarcinoma of the colon or rectum.

  2. Confirmed metastatic unresectable adenocarcinoma of the colon or the rectum.

  3. Confirmed non-microsatellite instability high (non-MSI-H)/mismatch-repair proficient (pMMR) tumor status

  4. Unequivocal and measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).

  5. Recurrent/progressing disease after at least one line of systemic therapy for metastatic disease which must include FOLFOX chemotherapy

  6. The patient is due to receive FOLFOX chemotherapy

  7. Neurotoxicity less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 from previous chemotherapy.

  8. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

  9. Adequate organ, hepatic, renal, pulmonary and cardiac functions

  10. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic Jacksonville Florida United States 32224
2 Moffit Cancer Center Tampa Florida United States 33612
3 UZ Antwerpen Edegem Belgium 2650
4 UZ Gent Ghent Belgium 9000
5 UZ Leuven Leuven Belgium 3000

Sponsors and Collaborators

  • Celyad Oncology SA
  • Merck Sharp & Dohme LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Celyad Oncology SA
ClinicalTrials.gov Identifier:
NCT04991948
Other Study ID Numbers:
  • CYAD-101-002
  • KEYNOTE-B79
First Posted:
Aug 5, 2021
Last Update Posted:
Mar 9, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 9, 2022