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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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. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03625323 |
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Recruitment Status :
Active, not recruiting
First Posted : August 10, 2018
Last Update Posted : October 24, 2023
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| NSCLC HNSCC | Drug: Eftilagimod alpha Drug: Pembrolizumab | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 189 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 |
| Actual Primary Completion Date : | June 2, 2022 |
| Estimated Study Completion Date : | November 2024 |
| Arm | Intervention/treatment |
|---|---|
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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:
Drug: Pembrolizumab anti-PD-1 antibody
Other Names:
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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:
Drug: Pembrolizumab anti-PD-1 antibody
Other Names:
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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:
Drug: Pembrolizumab anti-PD-1 antibody
Other Names:
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- Evaluation of objective response rate (ORR) according to iRECIST [ Time Frame: up to 24 month ]
- 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 ]
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.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Main Inclusion Criteria:
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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.
- Submission of formalin-fixed diagnostic tumor tissue
- ECOG performance status 0-1.
- Expected survival > 3 months.
Main Exclusion Criteria:
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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).
- Lung radiation therapy that is >30Gy within 6 months of the first dose of trial treatment.
For Part B (2nd line, PD-X refractory NSCLC):
- Symptomatic ascites or pleural effusion.
- > 1 line of chemotherapy for metastatic disease.
- Lung radiation therapy that is >30Gy within 6 months of the first dose of trial treatment.
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.
- 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)
- 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)
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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.
- 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 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.
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
Show 17 study locations
| Responsible Party: | Immutep S.A.S. |
| ClinicalTrials.gov Identifier: | NCT03625323 |
| 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: | October 24, 2023 |
| Last Verified: | October 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Squamous Cell Carcinoma of Head and Neck Neoplasms by Site Neoplasms Carcinoma, Squamous Cell Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Head and Neck Neoplasms Pembrolizumab Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action |