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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04811027




Registration number
NCT04811027
Ethics application status
Date submitted
19/03/2021
Date registered
23/03/2021
Date last updated
13/11/2023

Titles & IDs
Public title
Combination Study With Eftilagimod Alpha (a Soluble LAG-3 Fusion Protein) and Pembrolizumab in Patients With Recurrent or Metastatic HNSCC
Scientific title
TACTI-003 (Two ACTive Immunotherapeutics): A Multicenter, Open Label, Randomized, Phase II Trial to Investigate a Soluble LAG-3 Fusion Protein, Eftilagimod Alpha (Efti; IMP321) in Combination With Pembrolizumab (PD-1 Antagonist) for First Line Treatment of Subjects With Unresectable Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (HNSCC)
Secondary ID [1] 0 0
Keynote- PNC-34
Secondary ID [2] 0 0
TACTI-003
Universal Trial Number (UTN)
Trial acronym
TACTI-003
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HNSCC 0 0
Condition category
Condition code
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Eftilagimod alpha
Treatment: Drugs - Pembrolizumab

Experimental: (CPS =1): Pembro + Efti - Eftilagimod alpha: 30 mg every 2 weeks for the first 4 cycles;thereafter every 3 weeks for up to 18 cycles(1 cycle = 6 weeks).
Pembrolizumab: 400 mg every 6 weeks for up to 18 cycles (1 cycle = 6 weeks).

Active Comparator: (CPS =1): Pembro - Pembrolizumab: 400 mg every 6 weeks for up to 18 cycles (1 cycle = 6 weeks).

Experimental: (CPS <1): Pembro + Efti - Eftilagimod alpha: 30 mg every 2 weeks for the first 4 cycles;thereafter every 3 weeks for up to 18 cycles(1 cycle = 6 weeks).
Pembrolizumab: 400 mg every 6 weeks for up to 18 cycles (1 cycle = 6 weeks).


Treatment: Drugs: Eftilagimod alpha
APC activator, MHC II agonist, LAG-3 fusion protein

Treatment: Drugs: Pembrolizumab
anti-PD-1 antibody
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective response rate (ORR) according to RECIST1.1
Timepoint [1] 0 0
Up to 24 months
Secondary outcome [1] 0 0
Overall survival (OS)
Timepoint [1] 0 0
Up to 24 months
Secondary outcome [2] 0 0
Objective response rate (ORR) according to iRECIST
Timepoint [2] 0 0
Up to 24 months
Secondary outcome [3] 0 0
Time to and duration of responses according to iRECIST and RECIST 1.1
Timepoint [3] 0 0
Up to 24 months
Secondary outcome [4] 0 0
Disease control rate according to iRECIST and RECIST 1.1
Timepoint [4] 0 0
Up to 24 months
Secondary outcome [5] 0 0
Progression free survival (PFS) according to iRECIST and RECIST 1.1
Timepoint [5] 0 0
Up to 24 months
Secondary outcome [6] 0 0
Occurrence of anti-efti-specific antibodies
Timepoint [6] 0 0
Up to 24 months
Secondary outcome [7] 0 0
Frequency of (serious) adverse events
Timepoint [7] 0 0
Up to 24 months
Secondary outcome [8] 0 0
Severity of (serious) adverse events
Timepoint [8] 0 0
Up to 24 months
Secondary outcome [9] 0 0
Duration of (serious) adverse events
Timepoint [9] 0 0
Up to 24 months
Secondary outcome [10] 0 0
Quality of Life using EORTC QLQ-H&N35
Timepoint [10] 0 0
Up to 24 months

Eligibility
Key inclusion criteria
Main

1. Histologically- or cytologically-confirmed recurrent disease not amenable to curative
treatment with local or systemic therapy, or metastatic (disseminated) HNSCC of the
oral cavity, oropharynx, hypopharynx, or larynx that is considered incurable by local
therapies and to be treated in the first line palliative setting and who are PD-X
naïve.

2. Availability of tissue for PD-L1 biomarker analysis from a core or excisional biopsy.

3. Availability of PD-L1 biomarker result by using the FDA approved Dako standardized
diagnostic test (PD-L1 IHC 22C3 pharmDx).

4. Availability of tissue for testing of human papillomavirus (HPV) status for
oropharyngeal cancer (p16 expression testing).

5. ECOG performance status 0-1.

Main
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Disease is suitable for local therapy administered with curative intent.

2. Previously treated with = 1 systemic regimen for recurrent and/or metastatic disease
(with the exception of systemic therapy completed >6 months prior if given as part of
multimodal treatment for locally or locoregionally advanced disease).

3. Histologically or cytologically confirmed head and neck cancer of any other primary
anatomic location in the head and neck not specified in the inclusion criteria
including subjects with HNSCC of unknown primary, squamous cell carcinoma originating
from skin, or non-squamous histologies (e.g. nasopharynx, salivary gland or mucosal
melanoma).

4. Has progressive disease (PD) within 6 months of completion of curatively intended
systemic treatment for locally or locoregionally advanced HNSCC, or requires
chemotherapy based therapeutic regimen due to e.g., rapidly progressing disease or
need of aggressive sympton control.

5. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic
T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other
antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).

6. Has received prior chemotherapy, anti-cancer monoclonal antibody, major surgery,
another systemic cancer therapy or has participated in a trial of an investigational
agent or has used an investigational device within 4 weeks prior to cycle 1 day 1.

7. Known active central nervous system metastasis and/or carcinomatous meningitis.
Subjects with previously treated brain metastases may participate provided they are
radiologically stable: i.e. without evidence of progression documented by repeat
imaging performed after therapy completed for CNS metastasis and with at least 4 weeks
difference, clinically stable and without requirement for steroid treatment for at
least 14 days prior to cycle 1 day 1.

8. Receives continuous systemic treatment with either corticosteroids (>10 mg daily
prednisone equivalents) or other immunosuppressive medications within 7 days prior to
cycle 1 day 1. Inhaled or topical steroids and physiological replacement doses of up
to 10 mg daily prednisone equivalents are permitted in the absence of active
auto-immune disease.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2025
Actual
Sample size
Target
Accrual to date
Final
171
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Macquarie University Hospital - Macquarie Park
Recruitment postcode(s) [1] 0 0
2109 - Macquarie Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Missouri
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
Belgium
State/province [4] 0 0
Brugge
Country [5] 0 0
Belgium
State/province [5] 0 0
Edegem
Country [6] 0 0
Belgium
State/province [6] 0 0
Liège
Country [7] 0 0
Belgium
State/province [7] 0 0
Sint-Niklaas
Country [8] 0 0
Denmark
State/province [8] 0 0
Copenhagen
Country [9] 0 0
Denmark
State/province [9] 0 0
Herlev
Country [10] 0 0
Denmark
State/province [10] 0 0
Odense
Country [11] 0 0
Germany
State/province [11] 0 0
NRW
Country [12] 0 0
Germany
State/province [12] 0 0
Essen
Country [13] 0 0
Germany
State/province [13] 0 0
Heidelberg
Country [14] 0 0
Germany
State/province [14] 0 0
Ulm
Country [15] 0 0
Romania
State/province [15] 0 0
Cluj-Napoca
Country [16] 0 0
Spain
State/province [16] 0 0
Barcelona
Country [17] 0 0
Spain
State/province [17] 0 0
Girona
Country [18] 0 0
Spain
State/province [18] 0 0
Lugo
Country [19] 0 0
Spain
State/province [19] 0 0
Madrid
Country [20] 0 0
Spain
State/province [20] 0 0
Zaragoza
Country [21] 0 0
Ukraine
State/province [21] 0 0
AL
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Glasgow
Country [23] 0 0
United Kingdom
State/province [23] 0 0
London
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Manchester
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Nottingham

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Immutep S.A.S.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Merck Sharp & Dohme LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Evaluate the safety and efficacy of eftilagimod alpha in combination with pembrolizumab
against pembrolizumab alone in 1st line metastatic or recurrent HNSCC with PD-L1 positive
(CPS =1) tumors, and determine the efficacy and safety of efti plus pembrolizumab in patients
with PD-L1 negative tumors.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04811027
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04811027