SPEARHEAD 2 Study in Subjects With Recurrent or Metastatic Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT04408898|
Recruitment Status : Withdrawn (Challenges with recruitment)
First Posted : May 29, 2020
Last Update Posted : November 16, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Genetic: ADP-A2M4 in combination with pembrolizumab.||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Pilot Study of ADP-A2M4 in Combination With Pembrolizumab in Subjects With Recurrent or Metastatic Head and Neck Cancer|
|Actual Study Start Date :||July 2, 2020|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
|Experimental: ADP-A2M4 T cells in combination with pembrolizumab||
Genetic: 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
- Efficacy: Overall Response Rate (ORR) [ Time Frame: 2.5 years ]ORR is defined as the proportion of complete responses or partial responses as assessed by RECIST v1.1
- Best overall response (BOR) [ Time Frame: 2.5 years ]BOR defined as the best response recorded from the date of T cell infusion until disease progression.
- Time to response (TTR) [ Time Frame: 2.5 years ]TTR defined as the duration between T cell infusion and the initial date of the confirmed response.
- Duration of response (DoR) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 15 years ]Evaluation of RCL using PCR-based assay in peripheral blood.
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|Ages Eligible for Study:||18 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
- 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%.
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04408898
|United States, Arizona|
|Mayo Clinic Phoenix|
|Phoenix, Arizona, United States, 85054|
|United States, California|
|University of California San Diego|
|San Diego, California, United States, 92093|
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|United States, Michigan|
|Karmanos Cancer Insitute|
|Detroit, Michigan, United States, 48201|
|United States, Oregon|
|Providence Cancer Institute Franz Head and Neck Clinic|
|Portland, Oregon, United States, 97213|
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37212|
|United States, Texas|
|MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|United States, West Virginia|
|West Virginia University Cancer Institute|
|Morgantown, West Virginia, United States, 26506|
|Other Study ID Numbers:||
|First Posted:||May 29, 2020 Key Record Dates|
|Last Update Posted:||November 16, 2021|
|Last Verified:||November 2021|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Head and Neck Cancer
Head and Neck Neoplasms
Neoplasms by Site
Antineoplastic Agents, Immunological
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action