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临床试验/EUCTR2021-000055-39-ES
EUCTR2021-000055-39-ES进行中（未招募）1 期

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)

Immutep S.A.S.0 个研究点目标入组 154 人开始时间: 2021年7月13日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
154
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • •1. Willing to give written informed consent and to comply with the protocol.
  • •2. 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.
  • •3. Availability of tissue for PD-L1 biomarker analysis from a core or excisional biopsy (fine
  • •needle aspirate is not sufficient). A newly obtained biopsy (within 90 days prior to start of trial
  • •treatment) is preferred but an archival sample is acceptable.
  • •4. Availability of PD-L1 biomarker result by using the FDA approved Dako standardized
  • •diagnostic test (PD-L1 IHC 22C3 pharmDx).
  • •5. Availability of tissue for testing of human papillomavirus (HPV) status for oropharyngeal
  • •carcinoma (p16 expression testing).
  • •Note: If HPV status was previously tested using this method and result is available, no
  • •additional testing in central laboratory is required for this trial.
  • •6. Female or male =18 years of age on the day of signing the informed consent.
  • •7. All female subjects of childbearing potential must have a negative highly sensitive pregnancy
  • •test at screening (within 72 hours prior to cycle 1 day 1); all subjects of reproductive potential
  • •must agree to use highly effective method for contraception from trial entry until at least 4
  • •months after the last administration of any trial treatment.
  • •8. A woman must either be,
  • •a) not of childbearing potential: postmenopausal (= 60 years of age, or < 60 years of age and
  • •amenorrhoeic for 12 months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian
  • •suppression with follicle-stimulating hormone (FSH) above 40 U/L and estradiol below 30
  • •ng/L, or if taking tamoxifen or toremifene, and age < 60 years, then FSH and estradiol in the
  • •postmenopausal range), permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral
  • •salpingectomy), or otherwise incapable of pregnancy
  • •b) of childbearing potential and practicing a highly effective method of birth control consistent
  • •with local regulations regarding the use of birth control methods for subjects participating in
  • •clinical studies: e.g., established use of oral, injected or implanted hormonal methods of
  • •contraception; placement of an intrauterine device or intrauterine system; male partner
  • •sterilization (the vasectomized partner should be the sole partner for that subject).
  • •9. ECOG performance status 0-1.
  • •10. Evidence of measurable disease as defined by Response Evaluation Criteria in Solid Tumors
  • •version 1.1. Lesions situated in a previously irradiated area are considered measurable if
  • •progression has been demonstrated in such lesions.
  • •11. Subjects who are HBsAg positive are eligible if they have received HBV antiviral therapy for
  • •at least 4 weeks and have undetectable HBV viral load prior to randomization.
  • •Note: Subjects should remain on anti-viral therapy throughout study intervention and follow
  • •local guidelines for HBV anti-viral therapy post completion of trial intervention.
  • •Hepatitis B screening test are not required unless: a) known history of HBV infection; b)
  • •mandated by local health authority.
  • •12. Subjects with history of HCV infection are eligible if HCV viral load is undetectable at
  • •13. HIV infected subjects must be on anti-retroviral therapy and have a well-controlled HIV
  • •infection/disease defined as:

排除标准

  • •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 carcinoma 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 nonsquamous
  • •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 Tlymphocyte-
  • •associated antigen-4 antibody (including ipilimumab or any other
  • •antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
  • •6. No PD-L1 expression result available by cycle 1 day 1.
  • •7. Prior anti-LAG-3 therapy
  • •8. Prior high-dose chemotherapy requiring hematopoietic stem cell rescue.
  • •9. Prior targeted small molecule therapy , or radiation therapy within 2
  • •weeks prior to cycle 1 day 1.
  • •10. 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.
  • •11. 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.
  • •12. Pregnant, breastfeeding or expecting to conceive or father children within the projected
  • •duration of the trial starting with screening visit. A woman of child-bearing potential who has
  • •a positive serum pregnancy test (within 72 hours) prior to cycle 1 day 1.
  • •13. Serious intercurrent infection within 4 weeks prior to cycle 1 day 1 or active acute or chronic
  • •14. Evidence of severe or uncontrolled cardiac disease within 6 months prior to first dose of trial
  • •treatment including: myocardial infarction, severe/unstable angina, ongoing cardiac
  • •dysrhythmias of NCI CTCAE version 5.0 Grade = 2, atrial fibrillation > grade 2 not controlled
  • •by a pacemaker, coronary/peripheral artery bypass graft, symptomatic congestive heart failure
  • •(NYHA III-IV), cerebrovascular accident including transient ischemic attack, or symptomatic
  • •pulmonary embolism.
  • •15. Has interstitial lung disease or history of (non-infectious) pneumonitis that required steroids or
  • •has current pneumonitis.
  • •16. Has active autoimmune disease that has required systemic treatment in past 2 years (i.e., with
  • •use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement
  • •therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal
  • •or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
  • •17. HIV-infected subjects with a history of Kaposi sarcoma and/or Multicentric Castleman
  • •18. Has a life-threate

研究者

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