EUCTR2018-000789-13-FR进行中（未招募）1 期
A Randomized, Double-blind, Placebo-Controlled, Phase 2 Study of Cemiplimab Versus the Combination of Cemiplimab With ISA101b in the Treatment of Subjects With HPV16-Positive Platin-Resistant Oropharyngeal Cancer (OPC)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 164
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
入选标准
- •1. Males and females, = 18 years of age.
- •2. Sign and date an IRB/IEC approved written consent form.
- •4. Diagnosed with histologically confirmed recurrent or metastatic HPV16 positive OPC, not amenable to any therapy with curative intent. Subjects with HPV16 positive squamous cell carcinoma (SCC) of occult primary site, presenting with lymph node(s) in the neck, are also
- •5. HPV16 genotyping determined by polymerase chain reaction (PCR)-based assay. HPV genotyping requires a minimum of 10 unstained formalin-fixed paraffin-embedded (FFPE) slides of tumor sample (archival or recent).
- •6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- •7. Tumor progression or recurrence on or after platinum-containing chemotherapy for the treatment of primary, metastatic or recurrent disease, or within 6 months of platinumcontaining chemotherapy administered as part of neo-adjuvant or adjuvant therapy.
- •8. Measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension with a minimum size of 10 mm by computed tomography (CT) scanor magnetic resonance imaging (MRI) per RECIST 1.1 criteria. Indicator lesions must not have been previously treated with surgery, radiation therapy, or radiofrequency ablation, unless there is documented progression after therapy.
- •9. Fresh tumor tissue must be provided for biomarker correlative studies unless the investigator determines that this could impose a significant risk to the subject. It is recommended to discuss such cases with the Medical Monitor. Tumor lesions used for biopsy should not be lesions used as RECIST target lesion, unless there are no other lesions suitable for biopsy. If a RECIST target lesion is used for biopsy, the lesion must be = 2 cm in longest diameter.
- •10. Prior curative radiation therapy must have been completed at least 8 weeks prior to study drug administration. Prior focal palliative radiotherapy must have been completed at least 2 weeks before study drug administration.
- •11. Screening laboratory values must meet the following criteria (using National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v5.0) and should be obtained within 14 days prior to randomization:
- •i) White blood cell count (WBC) = 2 x 109/L
- •ii) Absolute neutrophil count (ANC) = 1.5 x 109/L
- •iii) Platelets = 100 x 109/L
- •iv) Hemoglobin = 9.0 g/dL
- •v) Serum creatinine = 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl)
- •vi) Hepatic function:
- •a. Total bilirubin = 1.5 x ULN (if liver metastases = 3 x ULN). Subjects with Gilbert’s
- •Disease and total bilirubin up to 3 x ULN may be eligible if total bilirubin
- •< 3.0 mg/dL.
- •b. Transaminases (ALT and AST) = 3 x ULN (or = 5.0 x ULN, if liver metastases)
- •c. Alkaline phosphatase = 2.5 x ULN (or = 5.0 x ULN, if liver or bone metastases)
- •If transaminase levels ( [AST] and/or [ALT]) > 3 x but = 5 x ULN, total bilirubin must be = 1.5 x ULN. If total bilirubin > 1.5 x but = 3 x ULN, both transaminases must be = 3 x ULN. Note regarding drug induced liver failure (DiLi): According to Hy's Law of Drug Induced Liver Injury a drug cau
排除标准
- •1. Subjects with known brain metastases or leptomeningeal metastases. Subjects with brain metastases are eligible if i) these have been treated, ii) there is no MRI (or CT scan where MRI is contraindicated) evidence of progression for at least 4 weeks after completion of the last treatment, iii) absence of new neurological signs/symptoms, and iv) there is no need for corticosteroid use for management of these lesions. Base of skull involvement without definitive evidence of dural or parenchymal (brain) involvement is acceptable.
- •2. Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration,impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results.
- •3. History of other malignancy = 3 years prior to entry into this trial with the exception of basal cell or squamous cell skin carcinoma(s) which were treated with local resection only, OR carcinoma in situ of the cervix, prostate or breast, OR low grade non-muscle invasive superficial bladder cancer (TaLG)/carcinoma in situ of the bladder.
- •4. Subjects with active, known, diagnosed or suspected auto-immune disease. Subjects suffering from vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring thyroid hormone replacement therapy, or psoriasis not requiring systemic treatment can be enrolled.
- •5. Patients diagnosed with active interstitial lung disease (ILD)/pneumonitis or a history of ILD/pneumonitis within the last 5 years, or another condition requiring immunosuppressive doses of systemic medication such as systemic corticosteroids or absorbed topical corticosteroids (doses = 10 mg/day prednisone or equivalent) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical corticosteroids and adrenal replacement doses < 10 mg daily prednisone or equivalent are permitted.
- •6. Subjects requiring maintenance treatment with immunosuppressive doses of systemic corticosteroids. Subjects being treated with a short course of corticosteroids (> 10 mg/day prednisone equivalents) should discontinue this therapy at least 2 weeks prior to start of study treatment.
- •7. Prior treatment with an anti-PD-1 antibody (e.g., nivolumab, pembrolizumab, cemiplimab), as well as anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
- •8. Prior treatment with therapeutic anti-HPV vaccines including ISA101 or ISA101b. Subjects who have received a preventive HPV vaccine are allowed.
- •9. Grade 1 or greater toxicities attributed to systemic prior anti-cancer therapy other than alopecia, fatigue (NCI CTCAE), radiation dermatitis, laboratory abnormalities that are not considered clinically significant by the treating physician, before administration of study drug. Subjects with residual grade 1 toxicities or toxicities attributed to systemic prior anticancer therapy that have become chronic and are not expected to resolve, such as neuropathy after platinum based therapy, can be included in this trial.
- •10. Invasive surgery (defined as surgical intervention requiring general or spinal anesthesia, and hospital admission)
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