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

  • STATUS
    Recruiting
  • End date
    Oct 5, 2036
  • participants needed
    10
  • sponsor
    Adaptimmune
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Updated on 5 August 2020
See if I qualify
cancer
HIV Infection
measurable disease
metastasis
pembrolizumab
squamous cell carcinoma of head and neck
squamous cell carcinoma
chemotherapy regimen
monoclonal antibodies
cyclophosphamide
ejection fraction
fludarabine
monoclonal antibody therapy
carcinoma
immunodeficiency
head and neck cancer
hepatitis b
pd-l1
neck cancer
recurrent disease
cns metastases
metastatic head and neck cancer
metastatic head and neck carcinoma

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.

Details
Condition head and neck cancer, head and neck cancer
Age 18years - 75years
Treatment ADP-A2M4 in combination with pembrolizumab.
Clinical Study IdentifierNCT04408898
SponsorAdaptimmune
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

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 nave and may have received prior platinum containing chemotherapy regimen
Measurable disease according to RECIST v1.1
HLA-A02 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

Exclusion Criteria

Positive for any HLA-A _02 allele other than: one of the inclusion alleles, HLA-A_ 02:07P or HLA-A02 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
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cancer
HIV Infection
measurable disease
metastasis
pembrolizumab
squamous cell carcinoma of head and neck
squamous cell carcinoma
chemotherapy regimen
monoclonal antibodies
cyclophosphamide
ejection fraction
fludarabine
monoclonal antibody therapy
carcinoma
immunodeficiency
head and neck cancer
hepatitis b
pd-l1
neck cancer
recurrent disease
cns metastases
metastatic head and neck cancer
metastatic head and neck carcinoma

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