SPEARHEAD 2 Study in Subjects With Recurrent or Metastatic Head and Neck Cancer
- Conditions
- Head and Neck Cancer
- Interventions
- Genetic: ADP-A2M4 in combination with pembrolizumab.
- Registration Number
- NCT04408898
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ADP-A2M4 T cells in combination with pembrolizumab ADP-A2M4 in combination with pembrolizumab. -
- Primary Outcome Measures
Name Time Method Efficacy: Overall Response Rate (ORR) 2.5 years ORR is defined as the proportion of complete responses or partial responses as assessed by RECIST v1.1
- Secondary Outcome Measures
Name Time Method Best overall response (BOR) 2.5 years BOR defined as the best response recorded from the date of T cell infusion until disease progression.
Time to response (TTR) 2.5 years TTR defined as the duration between T cell infusion and the initial date of the confirmed response.
Duration of response (DoR) 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) 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) 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) 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) 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 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 15 years Evaluation of RCL using PCR-based assay in peripheral blood.
Trial Locations
- Locations (8)
Mayo Clinic Phoenix
🇺🇸Phoenix, Arizona, United States
University of California San Diego
🇺🇸San Diego, California, United States
Providence Cancer Institute Franz Head and Neck Clinic
🇺🇸Portland, Oregon, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
West Virginia University Cancer Institute
🇺🇸Morgantown, West Virginia, United States
Karmanos Cancer Insitute
🇺🇸Detroit, Michigan, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States