Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT03625323
Previous Study | Return to List | Next Study

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)

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: NCT03625323
Recruitment Status : Recruiting
First Posted : August 10, 2018
Last Update Posted : June 30, 2020
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Immutep S.A.

Tracking Information
First Submitted Date  ICMJE July 16, 2018
First Posted Date  ICMJE August 10, 2018
Last Update Posted Date June 30, 2020
Actual Study Start Date  ICMJE February 18, 2019
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 9, 2018)
Evaluation of objective response rate (ORR) according to iRECIST [ Time Frame: up to 24 month ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 9, 2018)
  • Duration of (serious) adverse events [ Time Frame: up to 24 month ]
  • Frequency of (serious) adverse events [ Time Frame: up to 24 month ]
  • Severity of (serious) adverse events [ Time Frame: up to 24 month ]
  • Time to responses according to iRECIST and RECIST 1.1 [ Time Frame: up to 24 month ]
  • Duration of responses according to iRECIST and RECIST 1.1 [ Time Frame: up to 24 month ]
  • Response rate according to RECIST 1.1 [ Time Frame: up to 24 month ]
  • Disease control rate according to iRECIST and RECIST 1.1 [ Time Frame: up to 24 month ]
  • Progression free survival (PFS) [ Time Frame: up to 42 month ]
  • Overall survival (OS) [ Time Frame: up to 42 month ]
  • Occurrence of eftilagimod alpha-specific antibodies (ADA) [ Time Frame: up to 24 month ]
  • Plasma concentration time profile of eftilagimod alpha [ Time Frame: up to 24 month ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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)
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • NSCLC
  • HNSCC
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.

    Interventions:
    • Drug: Eftilagimod alpha
    • Drug: Pembrolizumab
  • 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.

    Interventions:
    • Drug: Eftilagimod alpha
    • Drug: Pembrolizumab
  • 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.

    Interventions:
    • Drug: Eftilagimod alpha
    • Drug: Pembrolizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 4, 2019)
109
Original Estimated Enrollment  ICMJE
 (submitted: August 9, 2018)
110
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Frederic Triebel +33660916539 frederic.triebel@immutep.com
Listed Location Countries  ICMJE Australia,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03625323
Other Study ID Numbers  ICMJE TACTI-002
Keynote-PN798 ( Other Identifier: Merck Sharp & Dohme Corp )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Immutep S.A.
Study Sponsor  ICMJE Immutep S.A.
Collaborators  ICMJE Merck Sharp & Dohme Corp.
Investigators  ICMJE Not Provided
PRS Account Immutep S.A.
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP