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临床试验/NL-OMON53614
NL-OMON53614已完成2 期

A Randomized, Double-Blind, Multicenter, Phase 2 Study of Retifanlimab in Combination With INCAGN02385 (Anti-LAG-3) and INCAGN02390 (Anti-TIM-3) as First-Line Treatment in Participants With PD-L1-Positive (CPS >= 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck - Incyte INCAGN 2385-203 Study

Incyte Biosciences International Sarl0 个研究点目标入组 6 人开始时间: 待定最近更新:
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适应症

试验速览

阶段
2 期
状态
已完成
入组人数
6
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

入排标准

年龄范围
18 至 99（—）

入选标准

  • •1. Ability to comprehend and willingness to sign a written ICF for the study.
  • •2. Age 18 years or older (or as applicable per local country requirements),
  • •inclusive at the time of signing the ICF.
  • •3. Histologically or cytologically confirmed R/M SCCHN that is not amenable to
  • •therapy with curative intent (surgery and/or radiation therapy with or without
  • •chemotherapy). Participants who refuse potentially curative salvage surgery for
  • •recurrent disease are ineligible.
  • •a. Eligible primary tumor locations are oropharynx, oral cavity, hypopharynx,
  • •and larynx.
  • •b.Participants with primary tumors of the nasopharynx, sinonasal cavity, or
  • •salivary gland are excluded.
  • •c.Participants must not have received prior systemic therapy for R/M SCCHN.
  • •4. PD-L1 positive tumor status defined by CPS >= 1% per central laboratory
  • •determination.
  • •5.For participants with primary oropharyngeal tumors, documentation of HPV p16
  • •status (positive or negative) based on local institutional standard is
  • •required. HPV p16 status is not required for other eligible SCCHN primary tumor
  • •6.Participant must have at least 1 measurable tumor lesion per RECIST v1.1.
  • •7.Availability of archival tissue for biomarker analysis from a core or
  • •excisional biopsy or willingness to undergo a fresh biopsy.
  • •8.ECOG performance status of 0 or 1.
  • •9.Willingness to avoid pregnancy or fathering children based on the criteria
  • •a. Male participants with reproductive potential must agree to take appropriate
  • •precautions to avoid fathering children from screening through 180 days after
  • •the last dose of study treatment and must refrain from donating sperm during
  • •this period.
  • •b. Female participants who are WOCBP must have a negative serum pregnancy test
  • •at screening and a negative urine pregnancy test before the first dose on Day 1
  • •and must agree to take appropriate precautions to avoid pregnancy from
  • •screening through 180 days after the last dose of study treatment and must
  • •refrain from donating oocytes during this period.
  • •c. Female participants not considered to be of childbearing potential

排除标准

  • •1. Progressive or recurrent disease within 6 months of the last dose of
  • •systemic treatment for locally advanced SCCHN.
  • •2. Prior PD-(L)1, LAG-3, or TIM-3 directed therapy, or any other checkpoint
  • •inhibitor therapy, for SCCHN (in any disease setting) or any other malignancy.
  • •3. Treatment with anticancer therapies or participation in another
  • •interventional clinical study within 21 days before the first administration of
  • •study treatment
  • •4. Presence of tumors that invade major blood vessels, as shown unequivocally
  • •by imaging, and with active bleeding.
  • •5. Less than 3-month life expectancy (based on investigator judgement).
  • •6. Participant has not recovered to <= Grade 1 or baseline from residual
  • •toxicities of prior therapy (with exceptions for anemia not requiring
  • •transfusion support, fatigue, or any grade of alopecia).
  • •7. Participant has not recovered adequately from toxicities and/or
  • •complications from surgical intervention before starting study treatment.
  • •8. Palliative radiation therapy administered within 1 week before the first
  • •dose of study treatment or radiation therapy in the thoracic region that is >
  • •30 Gy within 6 months before the first dose of study treatment.
  • •9. Known active CNS metastases and/or carcinomatous meningitis. Participants
  • •will be excluded if it has been < 4 weeks since radiation therapy was delivered
  • •to the CNS.
  • •10. Participants with laboratory values at screening as defined
  • •11. Has known active HBV or HCV, defined as follows (testing must be performed
  • •to determine eligibility):
  • •a. Active HBV is defined as a known positive HBsAg result and positive total
  • •anti-HBc results. Note: When HBsAg is negative AND HBcAb and/or
  • •HBsAb is positive, HBV-DNA should be measured. When HBV-DNA is negative, this
  • •participant could be enrolled with close monitoring of HBV activities.
  • •b. Active HCV is defined as a positive HCV antibody result and quantitative
  • •HCV-RNA results greater than the lower limits of detection of the assay. Note:
  • •Participants positive for HCV antibody will be eligible if they are negative
  • •for HCV-RNA. Participants who have had definitive treatment for HCV are
  • •permitted if HCV-RNA is undetectable.
  • •12. Participants who are known to be HIV-positive, unless all of the following
  • •criteria are met:
  • •a. CD4+ count >= 300/µL.
  • •b. Undetectable viral load.
  • •c. Receiving antiretroviral therapy that is not a potential risk for a
  • •drug-drug interaction with the assigned study drug.
  • •13. Any known additional malignancy that is progressing or requires active
  • •treatment, or history of other malignancy within 3 years of the first dose of
  • •study treatment with the exception of cured basal cell or squamous cell
  • •carcinoma of the skin, superficial bladder cancer, prostate intraepithelial
  • •neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent
  • •malignancy, or cancers from which the participant has been disease-free for > 1
  • •year after treatment with curative intent.
  • •14. Has active autoimmune disease requiring systemic immunosuppression with
  • •corticosteroids (> 10 mg/day of prednisone or equivalent) or immunosuppressive
  • •drugs within 2 years before the first dose of study treatment.
  • •15. Is on chronic systemic steroids (> 10 mg/day of prednisone or equivalent).
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