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SPEARHEAD 2 Study in Subjects With Recurrent or Metastatic Head and Neck 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04408898
Recruitment Status : Withdrawn (Challenges with recruitment)
First Posted : May 29, 2020
Last Update Posted : November 16, 2021
Sponsor:
Information provided by (Responsible Party):
Adaptimmune

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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Genetic: ADP-A2M4 in combination with pembrolizumab. Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Pilot Study of ADP-A2M4 in Combination With Pembrolizumab in Subjects With Recurrent or Metastatic Head and Neck Cancer
Actual Study Start Date : July 2, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ADP-A2M4 T cells in combination with pembrolizumab 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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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).

  5. 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.

  6. Overall survival (OS) [ Time Frame: 2.5 years ]
    OS defined the duration between T cell infusion and death due to any cause.

  7. 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

  8. 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.

  9. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria

  • Age ≥18 and <75 years
  • Diagnosis of head and neck squamous cell carcinoma with metastatic or unresectable, recurrent disease. confirmed by histology cytology.
  • Checkpoint inhibitor naïve and indicated for pembrolizumab or currently receiving pembrolizumab (monotherapy). May have received prior platinum containing chemotherapy regimen or checkpoint inhibitor therapy.
  • Subjects that have already received pembrolizumab (alone or in combination) and are progressing or have completed immune checkpoint inhibitor therapy for recurrent/metastatic disease, may still be enrolled and will skip Part A of the study.

These subjects will enroll into Part B when manufactured T cells are available.

  • Measurable disease according to RECIST v1.1.
  • HLA-A*02 positive by central laboratory.
  • Tumor shows MAGE-A4 expression confirmed by central laboratory.
  • 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.


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): NCT04408898


Locations
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United States, Arizona
Mayo Clinic Phoenix
Phoenix, Arizona, United States, 85054
United States, California
University of California San Diego
San Diego, California, United States, 92093
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Michigan
Karmanos Cancer Insitute
Detroit, Michigan, United States, 48201
United States, Oregon
Providence Cancer Institute Franz Head and Neck Clinic
Portland, Oregon, United States, 97213
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37212
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, West Virginia
West Virginia University Cancer Institute
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
Adaptimmune
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Responsible Party: Adaptimmune
ClinicalTrials.gov Identifier: NCT04408898    
Other Study ID Numbers: ADP 0044-003
First Posted: May 29, 2020    Key Record Dates
Last Update Posted: November 16, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Adaptimmune:
Cell Therapy
T-cell Therapy
SPEAR T-Cell
Head and Neck Cancer
MAGE-A4
ADP-A2M4
Immuno-oncology
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents