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Head and Neck CancerPhase 2NCT04408898

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

A Phase 2 study testing ADP-A2M4 in combination with pembrolizumab. in people with Head and Neck Cancer, run by Adaptimmune at 8 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Head and Neck Cancer
What is being tested?
ADP-A2M4 in combination with pembrolizumab.
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
8 sitesUnited States
Study dates
2 Jul 2020to Dec 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Karmanos Cancer Insitute

    Detroit, Michigan, 48201

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • West Virginia University Cancer Institute

    Morgantown, West Virginia, 26506

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37212

  • Mayo Clinic Phoenix

    Phoenix, Arizona, 85054

  • Providence Cancer Institute Franz Head and Neck Clinic

    Portland, Oregon, 97213

  • University of California San Diego

    San Diego, California, 92093

Other trials in United States

About this study

Official title: A Phase 2 Pilot Study of ADP-A2M4 in Combination With Pembrolizumab in Subjects With Recurrent or Metastatic Head and Neck Cancer

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.

Being tested
ADP-A2M4 in combination with pembrolizumab.
Keywords
Cell Therapy, T-cell Therapy, SPEAR T-Cell, Head and Neck Cancer, MAGE-A4, ADP-A2M4, Immuno-oncology
Medical subject headings
Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

Study groups in NCT04408898
Study groupRoleWhat they receive
ADP-A2M4 T cells in combination with pembrolizumabExperimentalNot described
Receives: Genetic: ADP-A2M4 in combination with pembrolizumab.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy: Overall Response Rate (ORR)

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

    Measured: 2.5 years

Secondary outcomes (9)

  1. Best overall response (BOR)

    BOR defined as the best response recorded from the date of T cell infusion until disease progression.

    Measured: 2.5 years

  2. Time to response (TTR)

    TTR defined as the duration between T cell infusion and the initial date of the confirmed response.

    Measured: 2.5 years

  3. Duration of response (DoR)

    DoR defined as the duration from the initial date of the confirmed response to the date of PD (or death).

    Measured: 2.5 years

  4. Duration of stable disease (DoSD)

    DoSD defined as the duration from the date of T cell infusion to the date of PD (or death).

    Measured: 2.5 years

  5. Progression- free survival (PFS)

    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.

    Measured: 2.5 years

  6. Overall survival (OS)

    OS defined the duration between T cell infusion and death due to any cause.

    Measured: 2.5 years

  7. To evaluate the safety and tolerability of ADP-A2M4 with pembrolizumab by determining incidence of Adverse events (AEs) including serious adverse events (SAEs)

    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

    Measured: 2.5 years

  8. To evaluate the safety and tolerability of ADP-A2M4 with pembrolizumab by determining the incidence, severity and duration of the AEs of special interest

    Adverse events of special interest will be listed along with duration and toxicity grade.

    Measured: 2.5 years

  9. To evaluate safety of ADP-A2M4 with pembrolizumab through measurement of Replication-competent Lentivirus in genetically engineered T-cells

    Evaluation of RCL using PCR-based assay in peripheral blood.

    Measured: 15 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2020
  2. Study start2 Jul 2020
  3. Primary completionDec 2021 (estimated)
  4. Study completionDec 2021 (estimated)

Why it stopped: Challenges with recruitment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04408898
Sponsor's protocol ID
ADP 0044-003
Status last verified
Nov 2021
First submitted
27 May 2020
Last updated
16 Nov 2021
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ADP-A2M4 in combination with pembrolizumab. in people with Head and Neck Cancer, run by Adaptimmune at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 16 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy: Overall Response Rate (ORR) (time frame: 2.5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04408898.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2021.

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