2024-515369-33-00招募中4 期
PHASE 1B/II TRIAL OF CHECKPOINT INHIBITOR (PEMBROLIZUMAB AND ANTI PD-1 ANTIBODY) PLUS STANDARD IMRT IN HPV INDUCED STAGE III SQUAMOUS CELL CARCINOMA OF ANUS
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Safety and tolerability of a combination of two different schedules of exposure to pembrolizumab concomitantly with standard CRT in patients with locally advanced anal cancer by assessing AEs / SAEs and extent of protocol adherence by trial population
研究概览
简要总结
To assess the safety and tolerability of two different schedules of exposure to pembrolizumab, an immune checkpoint inhibitor, concomitantly with standard CRT in patients with locally advanced T3/4 anal cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized
- 主要目的
- Pembrolizumab arm
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Be willing and able to provide written informed consent
- •Age 18 years or over on day of signing informed consent
- •Histologically proven Squamous Cell Cancer of Anus (SCCA) T3 / 4 N0 M0 or any N+ M0 or highly suspicious and confirmed by the MDT
- •Have a performance status of 0 or 1 on the ECOG Performance Scale
- •Demonstrate adequate organ function performed within 10 days of treatment initiation
- •Haematological: Absolute neutrophil count (ANC) ≥1.5 x 109/L, Platelets ≥100 x 109/L, Haemoglobin ≥9 g/dL or ≥5.6 Coagulation: International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 x ULN (unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants), Activated Partial Thromboplastin Time (aPTT) ≤1.5 x ULN (unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants). Renal: Serum creatinine ≤1.5 x upper limit of normal (ULN) OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≥60 mL/min for patient with creatinine levels > 1.5 x institutional ULN Hepatic Serum total bilirubin ≤ 1.5 x ULN OR Direct bilirubin ≤ ULN for patients with total bilirubin levels > 1.5 ULN mmol/L without transfusion or EPO dependency (within 7 days of assessment)
- •Female patient of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of trial medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- •Female patients of childbearing potential must be willing to use an adequate method of contraception for the course of the trial through 120 days after the last dose of trial medication.
- •Male patients must agree to use an adequate method of contraception starting with the first dose of trial therapy through 120 days after the last dose of trial therapy
排除标准
- •Has malignant tumour of non-epithelial origin (i.e. sarcoma)
- •Has a known additional malignancy that is progressing or requires active treatment.
- •Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
- •Has known history of, or any evidence of active, non-infectious pneumonitis.
- •Has an active infection requiring systemic therapy.
- •Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient’s participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator.
- •Has known psychiatric or substance abuse disorders that would make cooperation with the requirements of the trial challenging.
- •Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
- •Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
- •Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)
- •Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g. HCV RNA is detected).
- •Has any metastatic disease
- •Has received a live vaccine within 30 days of planned start of trial therapy.
- •Unsuitable for radical CRT for whatever reason
- •Is currently participating and receiving trial therapy or has participated in a trial of an investigational agent and received trial therapy or used an investigational device within 4 weeks of the first dose of treatment.
- •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.
- •Has a known history of active TB (Bacillus Tuberculosis).
- •Hypersensitivity to pembrolizumab or any of its excipients
- •Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to trial Day 1 or who has not recovered (i.e., ≤ Grade 1 at baseline) from adverse events due to agents administered more than 4 weeks earlier
- •Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to trial Day 1 or who has not recovered (i.e., ≤ Grade 1 at baseline) from adverse events due to a previously administered agent
结局指标
主要结局
Safety and tolerability of a combination of two different schedules of exposure to pembrolizumab concomitantly with standard CRT in patients with locally advanced anal cancer by assessing AEs / SAEs and extent of protocol adherence by trial population
Safety and tolerability of a combination of two different schedules of exposure to pembrolizumab concomitantly with standard CRT in patients with locally advanced anal cancer by assessing AEs / SAEs and extent of protocol adherence by trial population
次要结局
- Feasibility of combining pembrolizumab with standard CRT in two different schedules in patients with locally advanced anal cancer as measured by: Adherence to protocol treatment, as assessed by numbers of patients receiving per protocol treatment, dose delays, treatment reductions, treatment discontinuation and documenting the reasons for delays or discontinuation for each patient.
- Retention as assessed by the proportion of patients withdrawing from protocol treatment and number of patients lost to follow-up with documentation of reasons in each case.
- Recruitment rate as assessed by the number of days trial is open for recruitment, the number of patients screened, the number of screened patients not recruited and why and the number (proportion) of patients recruited.
- Trial eligibility as assessed by the number of patients eligible and ineligible at screening and reasons for ineligibility.
- Clinical response assessment for the overall response rate (ORR) at 12 weeks post-CRT and at 6 months post-CRT and 12 months follow up.
- Imaging response assessments by TRG MRI by changes in Apparent Diffusion Coefficient (ADC) on DW sequences. Immune related modified RECIST assessments (MRI) at 3 and 6 months post-CRT and at 12 months follow up.
- Patient-reported outcomes (PRO) using the EORTC tool during CRT, pembrolizumab monotherapy and 6 months post-CRT and 12 months follow-up to assess symptomatic toxicity both acute and late.
研究者
Margherita Carucci
Scientific
Cardiff University
研究点 (1)
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