EUCTR2018-000789-13-CZ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 Oropharyngeal Cancer (OPC) - Cemiplimab ± ISA101b in HPV16P-PtR-OPC
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 194
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. Males and females, = 18 years of age.
- •2. Willing and able to sign and date an IRB/IEC-approved written informed consent form.
- •3. Willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study.
- •4. Subjects with histologically confirmed recurrent or metastatic HPV16 positive OPC, whose tumors express PD-L1 (Combined Positive Score [CPS] =1) and who are candidates for first line therapy with an PD-1 blocking antibody, AND subjects with recurrent or metastatic HPV16 positive OPC with disease progression on or after platinum containing chemotherapy.
- •5. HPV16 genotyping determined by a specified central reference laboratory with an established polymerase chain reaction (PCR)-based assay. If local HPV16 genotype assessment has been performed, the subject can be enrolled if the result shows HPV16 positivity. Confirmation of HPV16 positive status will be performed retrospectively by the central laboratory.
- •6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- •7. 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) scan or 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.
- •8. Fresh tumor tissue is to be provided for biomarker and other correlative studies unless the investigator determines that this could impose a significant medical risk to the subject . It is recommended to discuss such cases with the Medical Monitor.
- •9. 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.
- •10. Screening laboratory values must meet the following criteria and should be obtained within 14 days prior to randomization:
- •i) White blood cell count (WBC) = 2x10e9/L
- •ii) Absolute neutrophil count (ANC) = 1.5x10e9/L
- •iii) Platelets = 100 x10e9/L
- •iv) Hemoglobin = 8.0 g/dL
- •v) Serum creatinine = 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl)> 40 mL/min
- •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)
- •Note for subjects with hepatic metastases: If transaminase levels (aspartate aminotransferase [AST] and/or alanine aminotransferase [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 (AST and ALT) must be = 3 x ULN.
- •Note regarding drug induced liver failure (DiLi): According to Hy's Law of Drug Induced Liver Injury a drug causes hepatocellular injury, generally defined as an elevated ALT or AST by 3-fold or greater above the upper limit of normal, combined with an elevation of serum total bilirubin of greater than 2× the upper limit of normal, without findings of cholestasis (defined as serum alkaline phosphatase activity less than 2× the upper limit of normal).
- •i) Calcium levels must be normalized and maintained within nor
排除标准
- •1. Subjects with previously untreated metastatic or unresectable, recurrent HPV16 positive OPC whose tumors do not express PD-L1 (CPS<1) and who are therefore not candidates for monotherapy with an anti-PD-1 antibody.
- •2. 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.
- •3. 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.
- •4. 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.
- •5. 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.
- •6. Patients diagnosed with active interstitial lung disease (ILD)/pneumonitis or a history of ILD/pneumonitis within the last 5 years, or another condition requiring
- •mmunosuppressive doses of 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.
- •7. Subjects requiring maintenance treatment with immunosuppressive doses of systemic corticosteroids.
- •8. 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.
- •9. Prior treatment with more than one chemotherapy regimen for the management of metastatic OPC.
- •10. Prior treatment with therapeutic anti-HPV vaccines including ISA101 or ISA101b. Subjects who have received a preventive HPV vaccine are allowed.
- •11. 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.
- •12. Prior treatment with other immune-modulating agents that was
- •(a) administered within 4 weeks (28 days) prior to the first dose of cemiplimab, OR
- •(b) associated with immune-mediated adverse events that were = Grade 1 within 90 days prior to the first dose of cemiplimab, OR
- •(c) associated with toxicity that resulted in discontinuation of the immune-modulating agent.
- •13. Invasive surgery (defined as surgical intervention requiring general or spinal anesthesia, and hospital admission) within 28 days prior to start of study treatment.
- •14. Subjects being treated or requiring treatment with:
研究者
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