Description:
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.
Title
- Brief Title: SPEARHEAD 2 Study in Subjects With Recurrent or Metastatic Head and Neck Cancer
- Official Title: A Phase 2 Pilot Study of ADP-A2M4 in Combination With Pembrolizumab in Subjects With Recurrent or Metastatic Head and Neck Cancer
Clinical Trial IDs
- ORG STUDY ID:
ADP 0044-003
- NCT ID:
NCT04408898
Conditions
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| ADP-A2M4 T cells in combination with pembrolizumab | Experimental | | |
Eligibility 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.
- 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.
| Maximum Eligible Age: | 75 Years |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Efficacy: Overall Response Rate (ORR) |
| Time Frame: | 2.5 years |
| Safety Issue: | |
| Description: | ORR is defined as the proportion of complete responses or partial responses as assessed by RECIST v1.1 |
Secondary Outcome Measures
| Measure: | Best overall response (BOR) |
| Time Frame: | 2.5 years |
| Safety Issue: | |
| Description: | BOR defined as the best response recorded from the date of T cell infusion until disease progression. |
| Measure: | Time to response (TTR) |
| Time Frame: | 2.5 years |
| Safety Issue: | |
| Description: | TTR defined as the duration between T cell infusion and the initial date of the confirmed response. |
| Measure: | Duration of response (DoR) |
| Time Frame: | 2.5 years |
| Safety Issue: | |
| Description: | DoR defined as the duration from the initial date of the confirmed response to the date of PD (or death). |
| Measure: | Duration of stable disease (DoSD) |
| Time Frame: | 2.5 years |
| Safety Issue: | |
| Description: | DoSD defined as the duration from the date of T cell infusion to the date of PD (or death). |
| Measure: | Progression- free survival (PFS) |
| Time Frame: | 2.5 years |
| Safety Issue: | |
| Description: | 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. |
| Measure: | Overall survival (OS) |
| Time Frame: | 2.5 years |
| Safety Issue: | |
| Description: | OS defined the duration between T cell infusion and death due to any cause. |
| Measure: | 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 |
| Safety Issue: | |
| Description: | 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 |
| Measure: | 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 |
| Safety Issue: | |
| Description: | Adverse events of special interest will be listed along with duration and toxicity grade. |
| Measure: | To evaluate safety of ADP-A2M4 with pembrolizumab through measurement of Replication-competent Lentivirus in genetically engineered T-cells |
| Time Frame: | 15 years |
| Safety Issue: | |
| Description: | Evaluation of RCL using PCR-based assay in peripheral blood. |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Adaptimmune |
Trial Keywords
- Cell Therapy
- T-cell Therapy
- SPEAR T-Cell
- Head and Neck Cancer
- MAGE-A4
- ADP-A2M4
- Immuno-oncology
Last Updated
April 29, 2021
