EUCTR2021-000055-39-BE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)
适应症
相关药物
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
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 isavailable, 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 30ng/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 is 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 screening.
- •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 or locoregionally 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 locally or locoregionally advanced HNSCC, or requires chemotherapy based therapeutic regimen due to e.g., rapidly progressing disease or need of aggressive symptom control.
- •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 infection.
- •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 ofsystemic
研究者
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