NCT04633278终止2 期
A Multicenter, Phase 2, Open-label Study of Intratumoral CMP-001 in Combination With Intravenous Pembrolizumab in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 19
- 主要终点
- Confirmed Objective Response Rate (ORR)
研究概览
简要总结
CMP-001-007 is a Phase 2 study of CMP-001 intratumoral (IT) and pembrolizumab intravenous (IV) administered to participants with head and neck squamous cell carcinoma (HNSCC) who have not been previously treated with a programmed cell death protein 1 (PD-1) blocking antibody.
The primary objective of the study is to determine the Investigator-assessed confirmed objective response with CMP-001 in combination with pembrolizumab in subjects with head and neck squamous cell carcinoma (HNSCC)
The secondary objectives are to:
- To evaluate the safety and tolerability of CMP-001 administered by intratumoral (IT) injection in combination with pembrolizumab in subjects with HNSCC
- To evaluate the efficacy of CMP-001 in combination with pembrolizumab in subjects with HNSCC
- To evaluate the effect of human papillomavirus (HPV) infection and programmed death-ligand 1 (PD-L1) expressions on the efficacy of CMP-001 in combination with pembrolizumab
Participants will continue to receive treatment of CMP-001 and pembrolizumab according to the treatment schedule until a reason for treatment discontinuation is reached.
详细描述
Former Sponsor Checkmate Pharmaceuticals
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically- or cytologically-confirmed recurrent or metastatic HNSCC considered incurable by local therapies.
- •No prior systemic therapy in the recurrent or metastatic setting. Systemic therapy as part of multi-modal treatment for locally advanced disease is allowed.
- •Primary tumor locations of oropharynx, oral cavity, hypopharynx, larynx or paranasal sinus. Participants may not have a primary tumor site of nasopharynx (any histology).
- •Able to provide tissue from a core or excisional biopsy (fine needle aspirate is not sufficient). A newly obtained biopsy (within 90 days before the start of study treatment) is preferred but an archival sample is acceptable.
- •Combined Positive Score (CPS) ≥ 1 for PD-L1 on Immunohistochemistry (IHC) of tumor tissue.
- •Have results of tumor HPV p16 by IHC for oropharyngeal cancer.
- •Measurable disease as defined by RECIST v1.1, and both of the following:
- •At least 1 lesion amenable to repeated Intratumoral (IT) injection.
- •Documented disease progression in any lesion that was previously radiated in order to serve as a target lesion.
- •Adequate organ function based on most recent laboratory values within 3 weeks before the first dose of study drug on Week 1 Day 1 (W1D1) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 at Screening.
- •Capable of understanding and complying with protocol requirements.
- •Women of childbearing potential must have negative serum pregnancy test during Screening and be willing to use an adequate method of contraception from the time of consent until at least 120 days after the last dose of study drug.
- •Male subjects must be surgically sterile or must agree to use adequate method of contraception from the time of consent until at least 120 days after the last dose of study drug.
- •Able and willing to provide written informed consent and to follow study instructions.
- •Subjects unable to provide written informed consent on their own behalf will not be eligible for the study.
排除标准
- •Disease suitable for local therapy administered with curative intent.
- •Has PD within 3 months of completion of curatively intent systemic treatment for locoregionally advanced HNSCC.
- •Radiation therapy (or other non-systemic therapy) within 2 weeks before the first dose of study drug on W1D
- •Received prior therapy with PD-1 or PD-L1 blocking antibody therapy in the recurrent/ metastatic setting. If PD-1 or PD-L1 blocking antibody therapy was given as part of curative intent therapy, it must be at least 1 year since receipt of PD-1 or PD-L1 blocking antibody.
- •Not fully recovered from adverse events (to Grade 1 or less [per CTCAE v5.0]), with the exception of persistent alopecia, neuropathy, ototoxicity, hypothyroidism, pain, or dysphagia, due to prior treatment.
- •Requires systemic pharmacologic doses of corticosteroids greater than the equivalent of 10 mg/day prednisone within 30 days before the first dose of study drug on W1D
- •Subjects who are currently receiving steroids at a prednisone-equivalent dose of ≤ 10 mg/day do not need to discontinue steroids prior to enrollment.
- •Replacement doses, topical, ophthalmologic, and inhalational steroids are permitted.
- •Active pneumonitis, history of noninfectious pneumonitis that required steroids, or history of interstitial lung disease.
- •Severe uncontrolled cardiac disease within 6 months of Screening, including but not limited to poorly controlled hypertension, unstable angina, myocardial infarction, congestive heart failure (New York Heart Association Class II or greater), pericarditis within the previous 6 months, cerebrovascular accident, implanted or continuous use of a pacemaker or defibrillator.
- •Known history of immunodeficiency.
- •Known additional malignancy that is progressing or required active treatment within the past 3 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, curatively treated localized prostate cancer with non-detectable prostate-specific antigen, in situ cervical cancer on biopsy or a squamous intraepithelial lesion on Papanicolaou smear, and thyroid cancer (except anaplastic).
- •Active autoimmune disease that has required systemic treatment in past 2 years; replacement therapy is not considered a form of systemic treatment
- •Untreated, symptomatic, or enlarging central nervous system (CNS) metastases or carcinomatous meningitis.
- •Prior allogenic tissue/solid organ transplant.
- •Active infection requiring systemic therapy.
- •Known or suspected active infection with SARS-CoV-2 virus.
- •Known or suspected infection with human immunodeficiency virus, hepatitis B virus or hepatitis C virus; testing is not required unless suspected.
- •Received a live virus vaccination within 30 days before the start of study drug dosing on W1D
- •Received blood products (including platelets or red blood cells) or colony stimulating factors [including granulocyte colony-stimulating factor (GCSF), granulocyte-macrophage colony-stimulating factor (GMCSF) (or recombinant erythropoietin)] within 30 days before the start of Screening.
- •Any concurrent uncontrolled illness, including mental illness or substance abuse, which in the opinion of the Investigator, would make the subject unable to cooperate or participate in the trial.
- •Participation in another clinical trial of an investigational anticancer therapy or device within 30 days before the first dose of study drug.
- •Requires prohibited treatment (ie. non-protocol specified anticancer pharmacotherapy, surgery or conventional radiotherapy for treatment of malignant tumor).
- •Has a life expectancy of less than 3 months and/or has rapidly progressing disease (eg. tumor bleeding, uncontrolled tumor pain) in the opinion of the treating Investigator.
- •Received previous CMP-001 treatment.
- •Pregnant or breast-feeding or expecting to conceive or father children within the projected duration of the study, from the time of consent until at least 120 days after the last dose of study drug.
研究组 & 干预措施
CMP-001 and Pembrolizumab
Experimental
All subjects will receive CMP-001 IT and pembrolizumab IV according to the treatment schedule until a reason for treatment discontinuation is reached.
干预措施: CMP-001 (Drug)
CMP-001 and Pembrolizumab
Experimental
All subjects will receive CMP-001 IT and pembrolizumab IV according to the treatment schedule until a reason for treatment discontinuation is reached.
干预措施: Pembrolizumab (Drug)
结局指标
主要结局
Confirmed Objective Response Rate (ORR)
时间窗: Up to approximately 109 weeks
Confirmed ORR is defined as the percentage of participants with a confirmed best overall response (BOR) of complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as determined by Investigator assessment (IA).
次要结局
- Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any Serious TEAE, and Any TEAE Leading to Discontinuation or Death(Up to approximately 109 weeks)
- Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0(Up to approximately 109 weeks)
- Duration of Response (DOR)(Up to approximately 28 months (120 weeks))
- Duration of Progression-free Survival (PFS)(Up to approximately 28 months (120 weeks))
- Duration of Overall Survival (OS)(From first dose up to approximately 28 months (120 weeks))
- Immune Objective Response Rate (iORR)(Up to approximately 109 weeks)
- Immune Progression-free Survival (iPFS)(Up to approximately 28 months (120 weeks))
- Confirmed ORR Based on Human Papillomavirus (HPV) Status(Up to approximately 109 weeks)
- Confirmed ORR Based on Programmed Death-ligand 1 (PD-L1) Expressions(Up to approximately 109 weeks)
- Duration of PFS Based on HPV Status(Up to approximately 28 months (120 weeks))
- Immune Duration of Response (iDOR)(Up to approximately 28 months (120 weeks))
- DOR Based on HPV Status(Up to approximately 28 months (120 weeks))
- DOR Based on PD-L1 Expressions(Up to approximately 28 months (120 weeks))
- PFS Based on PD-L1 Expressions(Up to approximately 28 months (120 weeks))
研究者
研究点 (19)
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