- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04811027
Combination Study With Eftilagimod Alpha (a Soluble LAG-3 Fusion Protein) and Pembrolizumab in Patients With Recurrent or Metastatic HNSCC (TACTI-003)
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)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Chief Medical Officer
- Phone Number: +49 30 88716843
- Email: enquiries@immutep.com
Study Locations
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Camperdown, Australia, NSW 2050
- Withdrawn
- Chris O'Brian Lifehouse
-
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New South Wales
-
East Albury, New South Wales, Australia, 2640
- Withdrawn
- Border Medical Oncology Research Unit
-
Macquarie Park, New South Wales, Australia, 2109
- Completed
- Macquarie University Hospital
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Brugge, Belgium, 8000
- Recruiting
- AZ Sint-Jan Brugge
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Contact:
- Alain Bols, Dr.
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Edegem, Belgium, 2650
- Recruiting
- Antwerp University Hospital
-
Contact:
- Marika Rasschaert, Dr.
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Liège, Belgium, 4000
- Recruiting
- Centre Hospitalier Universitaire (CHU) de Liege
-
Contact:
- Brieuc Sautois, Dr.
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Sint-Niklaas, Belgium, 9100
- Recruiting
- AZ Nikolaas
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Contact:
- Willem Lybaert, Dr.
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Copenhagen, Denmark, 2100
- Recruiting
- Rigshospitalet
-
Contact:
- Claus Andrup Kristensen, Dr
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Herlev, Denmark, 2700
- Recruiting
- Herlev Hospital
-
Contact:
- Jens Bentzen, Dr.
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Odense, Denmark, 5000
- Recruiting
- Odense University Hospital
-
Contact:
- Niels Gyldenkerne, Dr.
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Essen, Germany, 45147
- Recruiting
- University Hospital Essen
-
Contact:
- Stephan K Virchow, Prof.
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Heidelberg, Germany, 69120
- Recruiting
- Nationales Centrum für Tumorerkrankungen Heidelberg
-
Contact:
- Jürgen Krauss, Prof.
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Ulm, Germany, 89075
- Recruiting
- Universitatsklinikum Ulm
-
Contact:
- Simon Laban, Prof.
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NRW
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Bonn, NRW, Germany, 53127
- Recruiting
- Universitätsklinikum Bonn
-
Contact:
- Franz G Bauernfeind, MD
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Cluj-Napoca, Romania, 400015
- Recruiting
- The Oncology Institute "Prof Dr Ion Chiricuta" I.O.C.N.
-
Contact:
- Tudor E Ciuleanu, Prof.
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Barcelona, Spain, 08035
- Recruiting
- Vall d'Hebron Institute of Oncology (VHIO)
-
Contact:
- Irene Braña, Dr.
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Barcelona, Spain, 08041
- Recruiting
- Hospital de la Santa Creu i de Sant Pau
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Contact:
- Antonio López-Pousa, Dr.
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Girona, Spain, 17007
- Recruiting
- Institut Català d'Oncologia - Hospital Universitari de Girona
-
Contact:
- Jordi Rubió Casadevall, Dr.
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Lugo, Spain, 27003
- Recruiting
- Hospital Universitario Lucus Augusti
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Contact:
- Marta Covela Rua, Dr.
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Madrid, Spain, 28034
- Recruiting
- Hospital Universitario Ramon y Cajal
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Contact:
- Ainara Soria Rivas, Dr.
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Madrid, Spain, 28040
- Recruiting
- START Madrid (Hospital Universitario Fundación Jiménez Díaz)
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Contact:
- Bernard Doger de Spéville, Dr.
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Madrid, Spain, 28041
- Recruiting
- Hospital 12 Octubre
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Contact:
- Lara Iglesias, Dr.
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Zaragoza, Spain, 50009
- Recruiting
- Hospital Universitario Miguel Servet
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Contact:
- Maria E Ortega, Dr.
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AL
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Kapitanivka, AL, Ukraine, 08112
- Active, not recruiting
- Arensia Exploratory Medicine Llc
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Glasgow, United Kingdom, 1053
- Recruiting
- Institute of Cancer Science - Beatson West of Scotland Cancer Centre
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Contact:
- Derek Grose, Dr.
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London, United Kingdom, NW1 2PG
- Recruiting
- University College London Hospitals NHS Foundation - The Harley Street Clinic
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Contact:
- Martin Forster, Dr.
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Manchester, United Kingdom, M20 4BX
- Recruiting
- The Christie NHS Foundation Trust
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Contact:
- Robert Metcalf, Dr.
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Nottingham, United Kingdom, NG5 1PB
- Recruiting
- Nottingham University Hospitals, NHS Trust
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Contact:
- Judith Christian, Dr.
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Alabama
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Birmingham, Alabama, United States, 35249
- Recruiting
- University of Alabama at Birmingham (UAB) - O'Neal Cancer Center
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Contact:
- Lisle Nabell, Dr.
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Missouri
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Saint Louis, Missouri, United States, 63110
- Recruiting
- Washington University School of Medicine
-
Contact:
- Douglas Adkins, Dr.
-
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Texas
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Houston, Texas, United States, 77030
- Recruiting
- Oncology Consultants
-
Contact:
- Julio Peguero, Dr.
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Main Inclusion Criteria:
- 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.
- Availability of tissue for PD-L1 biomarker analysis from a core or excisional biopsy.
- Availability of PD-L1 biomarker result by using the FDA approved Dako standardized diagnostic test (PD-L1 IHC 22C3 pharmDx).
- Availability of tissue for testing of human papillomavirus (HPV) status for oropharyngeal cancer (p16 expression testing).
- ECOG performance status 0-1.
Main Exclusion Criteria:
- Disease is suitable for local therapy administered with curative intent.
- 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).
- 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).
- 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.
- 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).
- 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.
- 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.
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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). |
APC activator, MHC II agonist, LAG-3 fusion protein
Other Names:
anti-PD-1 antibody
Other Names:
|
Active Comparator: (CPS ≥1): Pembro
Pembrolizumab: 400 mg every 6 weeks for up to 18 cycles (1 cycle = 6 weeks).
|
anti-PD-1 antibody
Other Names:
|
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). |
APC activator, MHC II agonist, LAG-3 fusion protein
Other Names:
anti-PD-1 antibody
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Objective response rate (ORR) according to RECIST1.1
Time Frame: Up to 24 months
|
Up to 24 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival (OS)
Time Frame: Up to 24 months
|
Up to 24 months
|
Objective response rate (ORR) according to iRECIST
Time Frame: Up to 24 months
|
Up to 24 months
|
Time to and duration of responses according to iRECIST and RECIST 1.1
Time Frame: Up to 24 months
|
Up to 24 months
|
Disease control rate according to iRECIST and RECIST 1.1
Time Frame: Up to 24 months
|
Up to 24 months
|
Progression free survival (PFS) according to iRECIST and RECIST 1.1
Time Frame: Up to 24 months
|
Up to 24 months
|
Occurrence of anti-efti-specific antibodies
Time Frame: Up to 24 months
|
Up to 24 months
|
Frequency of (serious) adverse events
Time Frame: Up to 24 months
|
Up to 24 months
|
Severity of (serious) adverse events
Time Frame: Up to 24 months
|
Up to 24 months
|
Duration of (serious) adverse events
Time Frame: Up to 24 months
|
Up to 24 months
|
Quality of Life using EORTC QLQ-H&N35
Time Frame: Up to 24 months
|
Up to 24 months
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
PD-L1 expression
Time Frame: At Screening: three weeks prior to cycle 1 day 1
|
At Screening: three weeks prior to cycle 1 day 1
|
Circulating level of TH1 biomarker
Time Frame: Up to 24 months
|
Up to 24 months
|
Correlation of biomarkers or other characteristics with any efficacy or safety endpoint
Time Frame: Up to 24 months
|
Up to 24 months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Head and Neck Neoplasms
- Carcinoma, Squamous Cell
- Squamous Cell Carcinoma of Head and Neck
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Immune Checkpoint Inhibitors
- Pembrolizumab
Other Study ID Numbers
- TACTI-003
- Keynote- PNC-34 (Other Identifier: Merck Sharp & Dohme Corp)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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