EUCTR2016-002799-28-GB进行中（未招募）1 期
A phase Ib/II trial evaluating the combination of TG4001 and avelumab in patients with HPV-16 positive recurrent or metastatic malignancies including oropharyngeal squamous cell carcinoma of the head and neck (SCCHN)
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
- Transgene
- 入组人数
- 52
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
- •Female or male patients, aged at least 18 years (no upper limit of age)
- •ECOG PS 0 or 1
- •Life expectancy of at least 3 months
- •Patients with histologically or cytologically documented metastatic or refractory/recurrent HPV-16 + cancer (cervical, vulvar, vaginal, penile, anal cancers and oropharyngeal squamous cell carcinoma of head and neck).
- •Disease MUST not be amenable to curative surgery resection or curative radiotherapy with documented disease progression
- •Prior therapy: Patients MAY have received up to 2 prior lines of systemic chemotherapy for the management of metastatic or recurrent disease; for SCCHN, patients MUST have previously been exposed to platinum-based therapy, either as part of definitive chemo-radiation OR as first line systemic treatment for metastatic disease which may include cetuximab. Patients with recurrence/progression within 6 months of prior multimodal therapy using platinum-based therapy are eligible. Patients with cervical cancer may have undergone surgery and/or received definitive radiation or chemo-radiation therapy for localized disease.
- •Availability of tumor tissue from biopsy
- •At least one measurable lesion by CT scan according to RECIST 1.1.
- •Adequate hematological, hepatic and renal function
- •Negative blood pregnancy test at screening for women of childbearing potential
- •Highly effective contraception (i.e., methods with a failure rate of less than 1% per year) during the study period and for 3 months after the last study treatment administration for female patients of childbearing potential (WOCBP) and for male patients who are sexually active with WOCBP
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 36
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 16
排除标准
- •Prior exposure to cancer immunotherapy including cancer vaccines, any antibody/drug targeting T cell co-regulatory proteins (immune checkpoints)
- •Patients under chronic treatment with systemic corticosteroids or other immunosuppressive drugs for a period of at least 4 weeks and whose treatment was not stopped 2 weeks prior to the first study treatment, with the exception of patients with adrenal insufficiency who may continue corticosteroids at physiological replacement dose, equivalent to = 10 mg prednisone daily. Steroids with no or minimal systemic effect (topical, inhalation) are allowed
- •Patients with CNS metastases except those with brain metastases treated locally and clinically stable during 4 weeks prior to start of study treatment, and those without ongoing neurological symptoms that are related to the brain localization of the disease
- •Other active malignancy requiring concurrent systemic intervention
- •Patients with previous malignancies other than the target malignancy to be investigated in this trial (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study period
- •Patient with any organ transplantation, including allogeneic stem cell transplantation
- •Known severe hypersensitivity reactions to monoclonal antibodies (Grade = 3 NCI-CTC V4.03), any history of anaphylaxis, or uncontrolled asthma
- •Any known allergy or reaction to eggs, gentamycin or attributed to compounds of similar chemical or biological composition to therapeutic vaccines/immunotherapeutic products
- •Any known allergy or reaction to any component of anti-PD-L1/PD-1 or its excipients
- •Patients with history of interstitial lung disease
- •Patients with active, known, or suspected auto-immune disease or immunodeficiency, except type I diabetes mellitus, hypothyroidism only requiring hormone replacement or skin disorders (such as vitiligo, psoriasis) not requiring systemic treatment
- •Clinically significant (that is, active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction (< 6 months prior to enrollment), unstable angina pectoris, congestive heart failure (New York Heart Association Classification Class = II), or serious uncontrolled cardiac arrhythmia requiring medication/active intervention
- •History of uncontrolled intercurrent illness including but not limited to:
- •- Hypertension uncontrolled by standard therapies (not stabilized to 150/90 mmHg or lower)
- •- Uncontrolled diabetes (e.g., hemoglobin A1c = 8%)
研究者
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