EUCTR2019-003060-42-NO进行中（未招募）1 期
A Phase 2 Study in First Line Metastatic or Unresectable, Recurrent Head and Neck Squamous Cell Carcinoma to Evaluate Intratumoral MK-1454 in Combination with IV Pembrolizumab vs IV Pembrolizumab Monotherapy - Phase 2 Study in 1L HNSCC of IT MK-1454 / MK-3475 IV vs MK-3475 IV
Merck Sharp & Dohme Corp., a subsidiary of Merck &Co.,Inc0 个研究点目标入组 200 人开始时间: 2019年12月12日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
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. Has histologically or cytologically confirmed diagnosis of metastatic or unresectable,recurrent HNSCC that is considered incurable by local therapies.
- •Has not had prior systemic therapy administered in the recurrent or metastatic setting. Systemic therapy which was completed more than 6 months prior to signing consent, if given as part of multimodal treatment for locally advanced disease, is allowed.
- •The eligible primary tumor must be located in oropharynx, oral cavity, hypopharynx, or larynx. Participants may not have a primary tumor site of nasopharynx (any histology).
- •2. Has tumor PD-L1 expression of CPS =1.
- •3. Has measurable disease per RECIST 1.1, as assessed by BICR. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- •4. Has at least 1 measurable lesion which is amenable to injection. IT injection for cutaneous lesions may be performed via visual inspection. IT injection for subcutaneous lesions may be performed via ultrasound guidance or via palpation. This injectable lesion must be measurable and meet one of the following criteria:
- •-A cutaneous or subcutaneous lesion =1 cm in longest diameter for solid tumors, or =1.5 cm in short axis for a nodal lesion in solid tumor participants. The longest diameter for an injectable lesion must be =10 cm for both solid tumors and nodal lesions in solid tumor participants.
- •-Multiple coalescing, superficial lesions which in aggregate have a longest diameter of =1 cm and =10 cm.
- •5. Has an ECOG Performance Status of 0 or 1.
- •6. Demonstrates adequate organ function
- •7. Has results from testing of HPV status for oropharyngeal cancer defined as p16 IHC testing using CINtec® p16 Histology assay and a 70% cutoff point (please see the Procedures Manual for details). If HPV status was previously tested, then no additional testing is required.
- •8. Is male or female, from 18 years to unlimited years of age inclusive, at the time of signing the informed consent.
- •9. Male participants are eligible to participate if they agree to the following during the intervention period with MK-1454 and for at least 120 days after the last dose of MK 1454:
- •-Refrain from donating sperm
- •PLUS either:
- •-Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent
- •-Must agree to use contraception unless confirmed to be azoospermic
- •10. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
- •-Is not a WOCBP
- •-Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), during the intervention period and for at least 120 days after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period. The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention
- •-A WOCBP must have a negative highly sensitive pregnancy test (urine or serum) within 24 hours before the first dose of study intervention.
- •11. Contraceptive use by
排除标准
- •1.Has disease that is suitable for local therapy administered with curative intent
- •2. Has PD within 6 months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC
- •3. Has had chemotherapy or biological cancer therapy in the recurrent or metastatic setting for the treatment of HNSCC
- •4. Has had radiation therapy within 2 weeks prior to randomization or subject has not fully recovered from adverse events due to a previously administered treatment
- •5. Is expected to require any other form of antineoplastic therapy while on study
- •6. Has a history of a second malignancy, unless potentially curative treatment has been completed, with no evidence of malignancy for at least 2 years
- •7. Has clinically active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain or meningeal metastases may participate and be eligible for treatment provided they are stable and asymptomatic, have no evidence of new or enlarging brain metastases, are evaluated within 4 weeks prior to first study intervention administration, and are off immunosuppressive doses of systemic steroids at least 2 weeks prior to enrolment
- •8. Has an active autoimmune disease that has required systemic treatment in the past 2 years except vitiligo or resolved childhood asthma/atopy. Replacement therapy, such as thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, is not considered a form of systemic treatment and is allowed. Use of nonsystemic steroids is permitted
- •9. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Corticosteroid use as premedication for allergic reactions is allowed
- •10. Has had an allogenic tissue/solid organ transplant
- •11. Has a history of vasculitis
- •12. Has a history of interstitial lung disease
- •13. Has an active infection requiring systemic therapy
- •14. Has a known history of active tuberculosis
- •15. Has a history of pneumonitis that required steroids or current pneumonitis
- •16. Has had a severe hypersensitivity reaction to treatment a monoclonal antibody/component of the study intervention
- •17. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject’s participation for the full duration of the study in the opinion of the treating investigator
- •18. Participants with known Hepatitis B or C infections or known to be positive for HBsAg/HBV DNA or Hepatitis C Antibody or RNA.
- •19. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or if the patient has previously participated in Merck MK-3475 clinical trials
- •20. HIV infected participants who have had an HIV-related opportunistic infection within 6 months
- •21. HIV infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease
- •22. Has known psychiatric or substance abuse disorders that would interfere with the participant’s ability to cooperate with the requirements of the study
- •23. Is pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study intervention
- •24. Has not fully recovered from any effects of major surgery without significant detectable infection.
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