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SPEARHEAD 2 Study in Subjects With Recurrent or Metastatic Head and Neck Cancer

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ClinicalTrials.gov Identifier: NCT04408898
Recruitment Status : Recruiting
First Posted : May 29, 2020
Last Update Posted : March 1, 2021
Sponsor:
Information provided by (Responsible Party):
Adaptimmune

Tracking Information
First Submitted Date  ICMJE May 27, 2020
First Posted Date  ICMJE May 29, 2020
Last Update Posted Date March 1, 2021
Actual Study Start Date  ICMJE July 2, 2020
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2020)
Efficacy: Overall Response Rate (ORR) [ Time Frame: 2.5 years ]
ORR is defined as the proportion of complete responses or partial responses as assessed by RECIST v1.1
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2020)
  • Best overall response (BOR) [ Time Frame: 2.5 years ]
    BOR defined as the best response recorded from the date of T cell infusion until disease progression.
  • Time to response (TTR) [ Time Frame: 2.5 years ]
    TTR defined as the duration between T cell infusion and the initial date of the confirmed response.
  • Duration of response (DoR) [ Time Frame: 2.5 years ]
    DoR defined as the duration from the initial date of the confirmed response to the date of PD (or death).
  • Duration of stable disease (DoSD) [ Time Frame: 2.5 years ]
    DoSD defined as the duration from the date of T cell infusion to the date of PD (or death).
  • Progression- free survival (PFS) [ Time Frame: 2.5 years ]
    PFS defined as the interval between the date T cell infusion and the earliest date of disease progression based on RECIST v1.1 or death due to any cause.
  • Overall survival (OS) [ Time Frame: 2.5 years ]
    OS defined the duration between T cell infusion and death due to any cause.
  • To evaluate the safety and tolerability of ADP-A2M4 with pembrolizumab by determining incidence of Adverse events (AEs) including serious adverse events (SAEs) [ Time Frame: 2.5 years ]
    Determination of incidence, severity and duration of adverse events through assessment of adverse events including SAEs. Adverse events will be collected and graded as per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
  • To evaluate the safety and tolerability of ADP-A2M4 with pembrolizumab by determining the incidence, severity and duration of the AEs of special interest [ Time Frame: 2.5 years ]
    Adverse events of special interest will be listed along with duration and toxicity grade.
  • To evaluate safety of ADP-A2M4 with pembrolizumab through measurement of Replication-competent Lentivirus in genetically engineered T-cells [ Time Frame: 15 years ]
    Evaluation of RCL using PCR-based assay in peripheral blood.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SPEARHEAD 2 Study in Subjects With Recurrent or Metastatic Head and Neck Cancer
Official Title  ICMJE A Phase 2 Pilot Study of ADP-A2M4 in Combination With Pembrolizumab in Subjects With Recurrent or Metastatic Head and Neck Cancer
Brief Summary This is a study to investigate the efficacy and safety of ADP-A2M4 in combination with pembrolizumab in HLA-A*02 eligible and MAGE-A4 positive subjects with recurrent or metastatic Head and Neck cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Head and Neck Cancer
Intervention  ICMJE Genetic: ADP-A2M4 in combination with pembrolizumab.
Single infusion of autologous genetically modified ADP-A2M4 Dose: 1.0 x109 to 10x109 transduced cells by a single intravenous infusion Repeat doses of pembrolizumab every 3 weeks. Dose: 200mg
Study Arms  ICMJE Experimental: ADP-A2M4 T cells in combination with pembrolizumab
Intervention: Genetic: ADP-A2M4 in combination with 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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 27, 2020)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2036
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria

  • Age ≥18 and <75 years
  • Diagnosis of head and neck squamous cell carcinoma with metastatic or unresectable, recurrent disease. confirmed by cytogenetics.
  • Checkpoint inhibitor naïve and may have received prior platinum containing chemotherapy regimen.
  • Measurable disease according to RECIST v1.1.
  • HLA-A*02 positive
  • Tumor shows MAGE-A4 expression confirmed by central laboratory.
  • Tumors express PD-L1 [CPS ≥1]
  • ECOG Performance Status of 0 or 1.
  • Left ventricular ejection fraction (LVEF) ≥50%.

Note: other protocol defined Inclusion criteria may apply

Key Exclusion Criteria:

  • Positive for any HLA-A*02 allele other than: one of the inclusion alleles, HLA-A*02:07P or HLA-A*02 null alleles
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine, cyclophosphamide or other agents used in the study or history of severe hypersensitivity to another monoclonal antibody.
  • History of autoimmune or immune mediated disease
  • Leptomeningeal disease, carcinomatous meningitis or CNS metastases.
  • Other prior malignancy that is not considered by the Investigator to be in complete remission
  • Clinically significant cardiovascular disease
  • Uncontrolled intercurrent illness
  • Active infection with human immunodeficiency virus, hepatitis B virus, hepatitis C virus, or human T cell leukemia virus
  • Pregnant or breastfeeding

Note: other protocol defined Exclusion criteria may apply.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Adaptimmune Patient Enquiries 2158259260 patients@adaptimmune.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04408898
Other Study ID Numbers  ICMJE ADP 0044-003
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Adaptimmune
Study Sponsor  ICMJE Adaptimmune
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Adaptimmune
Verification Date October 2020

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