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Trial record 1 of 1 for:    TACTI002
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Combination Study With Soluble LAG-3 Fusion Protein Eftilagimod Alpha (IMP321) and Pembrolizumab in Patients With Previously Untreated Unresectable or Metastatic NSCLC, or Recurrent PD-X Refractory NSCLC or With Recurrent or Metastatic HNSCC (TACTI-002)

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ClinicalTrials.gov Identifier: NCT03625323
Recruitment Status : Recruiting
First Posted : August 10, 2018
Last Update Posted : March 15, 2019
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Immutep S.A.

Brief Summary:
Evaluate the safety and efficacy of the combination of eftilagimod alpha with pembrolizumab in non-small cell lung carcinoma and head and neck carcinoma patients.

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

Detailed Description:
Up to 120 patients will be recruited in the TACTI-002 (Two ACTive Immunotherapies) Phase II study which will take place across approximately 15 study centres in the U.S., Europe and Australia. It will evaluate the safety and efficacy of the combination of eftilagimod alpha with pembrolizumab in patients with advanced or metastatic non-small cell lung carcinoma or head and neck carcinoma. It will be a Simon's two-stage, non-comparative, open-label, single-arm, multicentre clinical study. Patients participating in the trial will be given the combination treatment for 12 months using a 30 mg s.c. eftilagimod alpha dosing every 2 or 3 weeks.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 109 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TACTI-002 (Two ACTive Immunotherapeutics): A Multicenter, Open Label, Phase II Study in Patients With Previously Untreated Unresectable or Metastatic Non-small Cell Lung Cancer (NSCLC), or Recurrent PD-X Refractory NSCLC or With Recurrent or Metastatic Squamous Head and Neck Cancer (HNSCC) Receiving the Soluble LAG-3 Fusion Protein Eftilagimod Alpha (IMP321) in Combination With Pembrolizumab (PD-1 Antagonist)
Actual Study Start Date : February 18, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1st line NSCLC

Eftilagimod alpha: 30 mg every 2 weeks for the first 8 cycles (1 cycle = 3 weeks) and every 3 weeks thereafter (starting cycle 9).

Pembrolizumab: 200 mg every 3 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

Experimental: 2nd line NSCLC

Eftilagimod alpha: 30 mg every 2 weeks for the first 8 cycles (1 cycle = 3 weeks) and every 3 weeks thereafter (starting cycle 9).

Pembrolizumab: 200 mg every 3 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

Experimental: HNSCC

Eftilagimod alpha: 30 mg every 2 weeks for the first 8 cycles (1 cycle = 3 weeks) and every 3 weeks thereafter (starting cycle 9).

Pembrolizumab: 200 mg every 3 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. Evaluation of objective response rate (ORR) according to iRECIST [ Time Frame: up to 24 month ]

Secondary Outcome Measures :
  1. Duration of (serious) adverse events [ Time Frame: up to 24 month ]
  2. Frequency of (serious) adverse events [ Time Frame: up to 24 month ]
  3. Severity of (serious) adverse events [ Time Frame: up to 24 month ]
  4. Time to responses according to iRECIST and RECIST 1.1 [ Time Frame: up to 24 month ]
  5. Duration of responses according to iRECIST and RECIST 1.1 [ Time Frame: up to 24 month ]
  6. Response rate according to RECIST 1.1 [ Time Frame: up to 24 month ]
  7. Disease control rate according to iRECIST and RECIST 1.1 [ Time Frame: up to 24 month ]
  8. Progression free survival (PFS) [ Time Frame: up to 42 month ]
  9. Overall survival (OS) [ Time Frame: up to 42 month ]
  10. Occurrence of eftilagimod alpha-specific antibodies (ADA) [ Time Frame: up to 24 month ]
  11. Plasma concentration time profile of eftilagimod alpha [ Time Frame: up to 24 month ]


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.


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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. Part A (1st line, PD-X naïve NSCLC): histologically- or cytologically-confirmed diagnosis of non-small cell lung carcinoma stage IIIB not amenable to curative treatment or stage IV not amenable to EGFR/ALK based therapy, treatment naïve for systemic therapy given for advanced/metastatic disease (previous palliative radiotherapy for advanced/metastatic disease acceptable)

    Part B (2nd line, PD-X refractory NSCLC): histologically- or cytologically-confirmed diagnosis of NSCLC after failure of first-line treatment (for metastatic disease) with at least 2 cycles of any PD-1/PD-L1 containing based therapy (e.g. nivolumab, pembrolizumab, avelumab, durvalumab, etc.) alone, or in combination with any other immunotherapeutic or chemotherapy given as part of first-line treatment.

    Part C (2nd line PD-X naive HNSCC): 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, and larynx that is considered incurable by local therapies after failure of prior platinum-based therapy.

  2. Submission of formalin-fixed diagnostic tumor tissue
  3. ECOG performance status 0-1.
  4. Expected survival > 3 months.

Main Exclusion Criteria:

  1. For part A (1st line, PD-X naïve NSCLC):

    • The NSCLC can be treated with curative intent with either surgical resection and/or chemoradiation and/or radiation.
    • Has received systemic therapy for the treatment of their stage IV NSCLC. Completion of treatment with chemotherapy and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as therapy was completed at least 6 months prior to the diagnosis of metastatic disease.
    • EGFR-sensitizing mutation and/or is EML4 gene/ ALK gene fusion positive (ALK translocation).

    For Part B (2nd line, PD-X refractory NSCLC):

    • Symptomatic ascites or pleural effusion.
    • > 1 line of chemotherapy for metastatic disease.

    For Part C (2nd line PD-X naive HNSCC):

    • Disease is suitable for local therapy administered with curative intent.
    • Previously treated with > 1 systemic regimens for recurrent and/or metastatic disease.
  2. 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) (Part A and C only)
  3. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137) and was discontinued from that treatment due to a Grade 3 or higher irAE (Part B only)
  4. Has received prior chemotherapy, anti-cancer monoclonal antibody, major surgery, another systemic cancer therapy or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to cycle 1 day 1.

    Note: Patients must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline. Patients with ≤Grade 2 neuropathy, alopecia and elevated transaminases in case of liver metastases may be eligible. If patient received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment. Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.

  5. Known active central nervous system metastasis and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are radiologically stable: i.e. without evidence of progression for at least 4 weeks by repeat imaging, clinically stable and without requirement for steroid treatment for at least 14 days prior to cycle 1 day 1.
  6. 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): NCT03625323


Contacts
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Contact: Frederic Triebel +33660916539 frederic.triebel@immutep.com

Locations
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United States, Texas
Oncology Consultants Recruiting
Houston, Texas, United States, 77030
Contact: Julio Peguero, Dr         
Australia, Queensland
Tasman Health Care Recruiting
Southport, Queensland, Australia, 4215
Contact: Pawan Bajaj, Dr         
Australia
St John of God Subiaco Hospital Recruiting
Perth, Australia, WA 6008
Contact: Tim Clay, MD    +61864659204    drclayoncologist@gmail.com   
Spain
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08025
Contact: Margarita Majem, Dr         
Vall d' Hebron Institute of Oncology (VHIO) Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Enriqueta Felip, Dr         
Institut Català d'Oncologia Badalona-Hospital Germans Trias i Pujol Recruiting
Barcelona, Spain, 08916
Contact: Enric Carcereny, Dr         
Fundación Jiménez Díaz Recruiting
Madrid, Spain, 28040
Contact: Bernard Doger, Dr         
Hospital Universitario 12 Octubre Recruiting
Madrid, Spain, 28041
Contact: Santiago Ponce, Dr         
United Kingdom
The Christie NHS Foundation Trust Recruiting
Manchester, United Kingdom, M20 4BX
Contact: Matthew Krebs, Dr         
Sponsors and Collaborators
Immutep S.A.
Merck Sharp & Dohme Corp.

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Responsible Party: Immutep S.A.
ClinicalTrials.gov Identifier: NCT03625323     History of Changes
Other Study ID Numbers: TACTI-002
Keynote-PN798 ( Other Identifier: Merck Sharp & Dohme Corp )
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents