SPEARHEAD 2 Study in Subjects With Recurrent or Metastati... | NCT04408898

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

NCT04408898

Sponsor

Adaptimmune

Status

Withdrawn

Last Update Posted

Nov 16, 2021Actual

Enrollment

0Actual

Phase

Phase 2

Conditions

Head and Neck Cancer

Interventions

ADP-A2M4 in combination with pembrolizumab.

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Challenges with recruitment

Expanded Access Info

Start Date

Jul 2, 2020Actual

Primary Completion Date

Dec 2021Estimated

Completion Date

Dec 2021Estimated

First Submitted Date

May 27, 2020

First Submission Date that Met QC Criteria

May 27, 2020

First Posted Date

May 29, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 8, 2021

Last Update Posted Date

Nov 16, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ADP-A2M4 T cells in combination with pembrolizumab	Experimental		Genetic: ADP-A2M4 in combination with pembrolizumab.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Best overall response (BOR)	BOR defined as the best response recorded from the date of T cell infusion until disease progression.	2.5 years
Time to response (TTR)	TTR defined as the duration between T cell infusion and the initial date of the confirmed response.

Other Outcomes

Not provided

Eligibility Module

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.
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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic Phoenix		Phoenix	Arizona	85054	United States
University of California San Diego

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms