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A Study of NG-641 and Pembrolizumab in Squamous Cell Carcinoma of the Head and Neck (MOAT)

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: NCT04830592
Recruitment Status : Recruiting
First Posted : April 5, 2021
Last Update Posted : January 18, 2023
Sponsor:
Information provided by (Responsible Party):
Akamis Bio

Study Description
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Brief Summary:
A multicentre, open-label, non-randomized, phase Ib neoadjuvant study of intravenous NG-641, as monotherapy or in combination with pembrolizumab, in patients with surgically resectable squamous cell carcinoma of the head and neck (SCCHN).

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma of the Head and Neck Biological: NG-641 Biological: Pembrolizumab Phase 1

Detailed Description:

Part A (NG-641 monotherapy): Approximately 16 evaluable patients will receive three doses of IV NG-641 in Part A. Patients will then proceed to planned surgical resection.

Part B (NG-641 and pembrolizumab): Up to 20 evaluable patients will receive three doses of IV NG-641 and one dose of pembrolizumab. Patients will then proceed to planned surgical resection.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicentre, Open-label, Dose-escalating, Phase Ib, Study of Intravenous Dosing of NG-641, as Monotherapy or in Combination With Pembrolizumab in Patients With Surgically Resectable Squamous Cell Carcinoma of the Head and Neck
Actual Study Start Date : November 4, 2021
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Part A
NG-641 monotherapy
 Biological: NG-641
Patients receive three doses of NG-641 by intravenous infusion.
Experimental: Part B
NG-641 and pembrolizumab
 Biological: NG-641
Patients receive three doses of NG-641 by intravenous infusion.

Biological: Pembrolizumab
Patients receive three doses of NG-641 by intravenous infusion and a single dose of Pembrolizumab by intravenous infusion.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of adverse events (safety and tolerability) [ Time Frame: End of Study Treatment Visit (Day 57) ]
    Assess the safety and tolerability of NG-641 by review of adverse events (AEs), serious adverse events, AEs resulting in delays to planned surgery, AEs leading to study treatment or study discontinuation and AEs resulting in death.


Eligibility Criteria
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Information from the National Library of Medicine

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.


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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

Inclusion Criteria:

  1. Newly diagnosed or recurrence of clinical stage III-IVb, histologically confirmed oral cavity, larynx, hypopharynx or oropharynx SCCHN (T1 with N2-3; T2 with N2-3; T3 with N0-3; T4a with N0-3)
  2. Disease is considered resectable, definitive surgery is planned in the next 8 weeks from screening, and the patient is willing to undergo surgery (potential for 2-3 cm of resected tumour specimen to be available for translational research purposes)
  3. Provide written informed consent to participate
  4. Aged 18 years or over
  5. Willing to consent to tumour biopsies at baseline
  6. ECOG performance status 0 or 1
  7. Ability to comply with study procedures in the Investigator's opinion
  8. Adequate renal function
  9. Adequate hepatic function
  10. Adequate bone marrow function
  11. Meeting reproductive status requirements

Exclusion Criteria:

  1. Prior allogeneic or autologous bone marrow or organ transplantation
  2. Active infections requiring antibiotics, physician monitoring or recurrent fevers (>38.0˚C) associated with a clinical diagnosis of active infection. Active infection requiring systemic therapy within 1 week of the anticipated first dose of study drug
  3. Active viral disease or positive test for hepatitis B virus, hepatitis C virus (HCV) or HIV/AIDS
  4. Patients who have active autoimmune disease that has required systemic therapy in the past 2 years, are immunocompromised in the opinion of the Investigator, or are receiving systemic immunosuppressive treatment (see protocol for full criteria)
  5. Treatment with any COVID-19 vaccine in the 28 days before the first dose of NG-641, unless the vaccine is known to not be based on an adenoviral vector (e.g., mRNA vaccines)
  6. Treatment with any vaccine (including known non-adenoviral COVID-19 vaccines) in the 7 days before first dose of NG-641
  7. History of clinically significant chronic liver disease
  8. History of clinically significant interstitial lung disease (including pneumonitis)
  9. History of prior Grade 3-4 acute kidney injury or other clinically significant renal impairment
  10. Use of antiviral agents
  11. Incomplete recovery from surgery, incomplete healing of an incision site or evidence of infection
  12. Any of the following in the 3 months before the first dose of study treatment: Grade 3 or 4 gastrointestinal bleeding or risk factors for gastrointestinal bleeding, infectious or inflammatory bowel disease, pulmonary embolism or other uncontrolled thromboembolic event, history or evidence of haemoptysis, or significant cardiovascular or cerebrovascular event
  13. Any known Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥2 coagulation abnormality/coagulopathy
  14. Prior history of bowel obstruction, or infectious or inflammatory bowel disease in the 3 months before the first dose of study treatment

  15. Major surgery or treatment with any chemotherapy, radiation therapy, biologics for cancer or investigational drug/therapy in the 28 days before the first dose of study treatment:

    • All toxicities attributed to prior anti-cancer therapy other than alopecia must have resolved to Grade 1 or baseline before the first dose of study treatment. Patients with toxicities (other than renal toxicities) attributed to prior anti-cancer therapy which are not expected to resolve and result in long lasting sequelae, such as neuropathy after platinum-based therapy, are permitted to enrol

  16. Other prior malignancy active within the previous 3 years
  17. Tumour location/extent considered by the Investigator to present a significant risk of airway obstruction if tumour flare or necrosis were to occur
  18. Any serious or uncontrolled medical disorder that, in the opinion of the Investigator or the Medical Monitor, may increase the risk associated with study participation or study treatment administration, impair the ability of the patient to receive protocol therapy or interfere with the interpretation of study results
  19. Previous treatment with any other enadenotucirev-based therapy, or fibroblast activation protein (FAP) targeting agent
  20. Known allergy/immune-related adverse reactions to NG-641 transgene or immune checkpoint inhibitor products or formulation; severe hypersensitivity to another monoclonal antibody
  21. Any other medical or psychological condition that would affect the patient's ability to comply with all visits and assessments, or compromise ability to give informed consent
  22. Related to or a dependent of the site staff, or a member of the site staff.
Contacts and Locations
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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): NCT04830592


Contacts
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Contact: Akamis Bio +44 (0)1235 835 328 enquiries@akamisbio.com

Locations
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United Kingdom
Cardiff & Vale University LHB Recruiting
Cardiff, United Kingdom
Contact: Mererid Evans, Dr         
The Clatterbridge Cancer Centre Recruiting
Liverpool, United Kingdom
Contact: Christian Ottensmeier, Prof.         
The Royal Marsden Hospital Recruiting
London, United Kingdom
Contact: Kevin Harrington, Prof.         
University Hospital Southampton NHS Foundation Trust Recruiting
Southampton, United Kingdom, SO16 6YD
Contact: Ioannis Krydis, Dr         
Sponsors and Collaborators
Akamis Bio
Investigators
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Principal Investigator: Christian Ottensmeier, Prof. The Clatterbridge Cancer Centre
More Information
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Responsible Party: Akamis Bio
ClinicalTrials.gov Identifier: NCT04830592    
Other Study ID Numbers: NG-641-02
First Posted: April 5, 2021    Key Record Dates
Last Update Posted: January 18, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Akamis Bio:
Squamous cell carcinoma of the head and neck
SCCHN
NG-641
Pembrolizumab
PsiOxus
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
 Head and Neck Neoplasms
Neoplasms by Site
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action