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

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ClinicalTrials.gov Identifier: NCT04830592
Recruitment Status : Not yet recruiting
First Posted : April 5, 2021
Last Update Posted : April 9, 2021
Sponsor:
Information provided by (Responsible Party):
PsiOxus Therapeutics Ltd

Tracking Information
First Submitted Date  ICMJE March 31, 2021
First Posted Date  ICMJE April 5, 2021
Last Update Posted Date April 9, 2021
Estimated Study Start Date  ICMJE June 2021
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 31, 2021)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of NG-641 and Pembrolizumab in Squamous Cell Carcinoma of the Head and Neck
Official Title  ICMJE 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
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).
Detailed Description

Part A (NG-641 monotherapy): Up to 18 patients will be dosed with intravenous NG-641. Patients will then proceed to planned surgical resection.

Part B (NG-641 and pembrolizumab): Up to 30 patients will be dosed with intravenous NG-641 before receiving a single dose of pembrolizumab. Patients will then proceed to planned surgical resection.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Squamous Cell Carcinoma of the Head and Neck
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Part A
    NG-641 monotherapy
    Intervention: Biological: NG-641
  • Experimental: Part B
    NG-641 and pembrolizumab
    Interventions:
    • Biological: NG-641
    • Biological: Pembrolizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 31, 2021)
48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Newly diagnosed or recurrence of clinical stage III-IVb histologically confirmed oral cavity, larynx, hypopharynx or oropharynx squamous cell carcinoma of the head and neck (SCCHN)
  2. Disease is considered resectable, definitive surgery is planned in the next 8 weeks from screening, and the patient is willing to undergo surgery
  3. Known human papillomavirus (HPV) status for oropharyngeal cancer
  4. Provide written informed consent to participate
  5. Aged 18 years or over
  6. Willing to consent to tumour biopsies at baseline
  7. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  8. Ability to comply with study procedures in the Investigator's opinion
  9. Adequate renal function
  10. Adequate hepatic function
  11. Adequate bone marrow function
  12. Coagulation profile within the normal range
  13. Meeting the reproductive status requirements of the study

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 using hepatitis B surface antigen test or positive test for hepatitis C virus (HCV) using HCV ribonucleic acid (RNA) or HCV antibody test indicating acute or chronic infection. Positive test for HIV or 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
  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. messenger RNA (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 the following antiviral agents: ribavirin, adefovir, lamivudine or cidofovir within 7 days prior to the first dose of study treatment; or pegylated interferon (PEG-IFN) in the 14 days before the first dose of study treatment
  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 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
  16. Other prior malignancy active within the previous 3 years, except for local or organ confined early stage cancer that has been definitively treated with curative intent, does not require ongoing treatment, has no evidence of residual disease and has a negligible risk of recurrence and is therefore unlikely to interfere with the primary and secondary endpoints of the study, including response rate and safety
  17. Tumour location/extent considered by the Investigator to present a significant risk of airway obstruction if tumour flare or necrosis were to occur (e.g. an initial increase in tumour size that may lead to intestinal, airway or ureter obstruction, or penetrating tumour infiltration of major blood vessels, or other hollow organs potentially at risk of perforation)
  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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: PsiOxus Therapeutics +44 (0)1235 835 328 enquiries@psioxus.com
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04830592
Other Study ID Numbers  ICMJE NG-641-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party PsiOxus Therapeutics Ltd
Study Sponsor  ICMJE PsiOxus Therapeutics Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christian Ottensmeier, Prof. The Clatterbridge Cancer Centre
PRS Account PsiOxus Therapeutics Ltd
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP