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

NCT04408898 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: ADP 0044-003
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 8

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.

Conditions

Head and Neck Cancer

Keywords

Cell Therapy; T-cell Therapy; SPEAR T-Cell; Head and Neck Cancer; MAGE-A4; ADP-A2M4; Immuno-oncology

Outcome Measures

Primary Outcomes (1)

• Efficacy: Overall Response Rate (ORR)

  ORR is defined as the proportion of complete responses or partial responses as assessed by RECIST v1.1

  2.5 years

Secondary Outcomes (9)

• Best overall response (BOR)

  2.5 years

• Time to response (TTR)

  2.5 years

• Duration of response (DoR)

  2.5 years

• Duration of stable disease (DoSD)

  2.5 years

• Progression- free survival (PFS)

  2.5 years

Study Arms (1)

ADP-A2M4 T cells in combination with pembrolizumab

EXPERIMENTAL

Genetic: ADP-A2M4 in combination with pembrolizumab.

Interventions

ADP-A2M4 in combination with pembrolizumab. GENETIC

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

ADP-A2M4 T cells in combination with pembrolizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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

Sponsors & Collaborators

• Adaptimmune: lead

Study Sites (8)

Mayo Clinic Phoenix

Phoenix, Arizona, 85054, United States

Location

University of California San Diego

San Diego, California, 92093, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Karmanos Cancer Insitute

Detroit, Michigan, 48201, United States

Location

Providence Cancer Institute Franz Head and Neck Clinic

Portland, Oregon, 97213, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37212, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

West Virginia University Cancer Institute

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: May 29, 2020
• Study Start: July 2, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: November 16, 2021

Record last verified: 2021-11

Locations

US (8)