SPEARHEAD 2 Study in Subjects With Recurrent or Metastatic Head and Neck Cancer
NCT ID: NCT04408898
Last Updated: 2021-11-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2020-07-02
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ADP-A2M4 T cells in combination with pembrolizumab
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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%.
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Adaptimmune
INDUSTRY
Responsible Party
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Locations
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Mayo Clinic Phoenix
Phoenix, Arizona, United States
University of California San Diego
San Diego, California, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Karmanos Cancer Insitute
Detroit, Michigan, United States
Providence Cancer Institute Franz Head and Neck Clinic
Portland, Oregon, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
West Virginia University Cancer Institute
Morgantown, West Virginia, United States
Countries
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Other Identifiers
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ADP 0044-003
Identifier Type: -
Identifier Source: org_study_id