Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Combination Study With Eftilagimod Alpha (a Soluble LAG-3 Fusion Protein) and Pembrolizumab in Patients With Recurrent or Metastatic HNSCC (TACTI-003)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04811027
Recruitment Status : Recruiting
First Posted : March 23, 2021
Last Update Posted : November 4, 2021
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Immutep S.A.S.

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.

Condition or disease Intervention/treatment Phase
HNSCC Drug: Eftilagimod alpha Drug: Pembrolizumab Phase 2

Detailed Description:
Up to 154 patients will be recruited in the TACTI-003 (Two ACTive Immunotherapies) Phase IIb study which will take place across several countries in Australia, Europe and United States of America in up to 35 experienced clinical sites. It will 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. Subjects in cohort A (CPS ≥1) will be randomized 1:1 to receive either "P+E": efti plus pembrolizumab or "P only": pembrolizumab alone. Subjects in cohort B (CPS <1) will receive a combination of efti and pembrolizumab "P+E". Efti will be administered for up to 24 months using a 30 mg s.c. dosing every 2 or 3 weeks. Pembrolizumab will be administered for up to 24 months using a 400mg i.v. (30 min) dosing every 6 weeks.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : August 27, 2021
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : March 2025

Resource links provided by the National Library of Medicine


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).

Drug: Eftilagimod alpha
APC activator, MHC II agonist, LAG-3 fusion protein
Other Names:
  • IMP321
  • Efti

Drug: Pembrolizumab
anti-PD-1 antibody
Other Names:
  • Keytruda
  • MK-3475

Active Comparator: (CPS ≥1): Pembro
Pembrolizumab: 400 mg every 6 weeks for up to 18 cycles (1 cycle = 6 weeks).
Drug: Pembrolizumab
anti-PD-1 antibody
Other Names:
  • Keytruda
  • MK-3475

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).

Drug: Eftilagimod alpha
APC activator, MHC II agonist, LAG-3 fusion protein
Other Names:
  • IMP321
  • Efti

Drug: Pembrolizumab
anti-PD-1 antibody
Other Names:
  • Keytruda
  • MK-3475




Primary Outcome Measures :
  1. Objective response rate (ORR) according to RECIST1.1 [ Time Frame: Up to 24 months ]

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

Other Outcome Measures:
  1. PD-L1 expression [ Time Frame: At Screening: three weeks prior to cycle 1 day 1 ]
  2. Circulating level of TH1 biomarker [ Time Frame: Up to 24 months ]
  3. Correlation of biomarkers or other characteristics with any efficacy or safety endpoint [ Time Frame: Up to 24 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  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 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 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 locoregionally advanced HNSCC.
  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.

Information from the National Library of Medicine

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): NCT04811027


Contacts
Layout table for location contacts
Contact: Frederic Triebel +33660916539 frederic.triebel@immutep.com

Locations
Layout table for location information
United States, Texas
Oncology Consultants Recruiting
Houston, Texas, United States, 77030
Contact: Julio Peguero, Dr.         
Ukraine
Arensia Exploratory Medicine Llc Recruiting
Kapitanivka, AL, Ukraine, 08112
Contact: Valeriy Cheshuk, Prof.         
Sponsors and Collaborators
Immutep S.A.S.
Merck Sharp & Dohme Corp.
Layout table for additonal information
Responsible Party: Immutep S.A.S.
ClinicalTrials.gov Identifier: NCT04811027    
Other Study ID Numbers: TACTI-003
Keynote- PNC-34 ( Other Identifier: Merck Sharp & Dohme Corp )
First Posted: March 23, 2021    Key Record Dates
Last Update Posted: November 4, 2021
Last Verified: October 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Immutep S.A.S.:
HNSCC
Additional relevant MeSH terms:
Layout table for MeSH terms
Squamous Cell Carcinoma of Head and Neck
Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents