NCT02919969已完成2 期
A Multicenter Phase 2 Clinical Trial of Pembrolizumab in Metastatic Anal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 4
- 主要终点
- Overall Response Rate
研究概览
简要总结
This research study is studying a targeted therapy as a possible treatment for advanced anal cancer.
The following intervention will be involved in this study:
-Pembrolizumab
详细描述
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied.
The FDA (the U.S. Food and Drug Administration) has not approved pembrolizumab for Advanced Anal Cancer, but it has been approved for other uses.
Pembrolizumab, also known as KEYTRUDA or MK-3475, is approved in the USA and several other countries to treat a type of skin cancer called Malignant Melanoma.
In this research study the investigators are studying an investigational drug called Pembrolizumab, which is a monoclonal antibody. Monoclonal antibodies are manmade and mimic proteins in the immune system by attaching to specific proteins in the body. T cells are cells in the immune system that are controlled by PD-1. PD-1 is a protein on the T cells that prevent the body from overproducing T cells. Pembrolizumab targets PD-1, attaches to it and blocks its action. By preventing PD-1 from working, T cell production rises and the body's immune system may increase its action against Cancer cells. Clinical and laboratory studies using pembrolizumab suggest that pembrolizumab may be useful in shrinking certain tumors.
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
- •Participants must have metastatic anal cancer that has been histologically confirmed.
- •There is no limit to the number of prior therapies.
- •Be willing and able to provide written informed consent/assent for the trial.
- •Be ≥18 years of age on day of signing informed consent.
- •Have measurable disease based on RECIST 1.
- •Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day
- •Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the Sponsor.
- •Have a performance status of 0 or 1 on the ECOG Performance Scale.
- •Demonstrate adequate organ function, all screening labs must be performed within 10 days of treatment initiation.
- •Adequate Organ Function Laboratory Values
- •System Laboratory Value
- •Hematological
- •Absolute neutrophil count (ANC) ≥1,500 /mcL
- •Platelets ≥80,000 / mcL
- •Hemoglobin ≥8.5 g/dL or ≥5.6 mmol/L
- •-Serum creatinine OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 X upper limit of normal (ULN) OR ≥60 mL/min for subject with creatinine levels > 1.5 X institutional ULN
- •Serum total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN
- •AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases
- •Albumin >2.8 mg/dL
- •Coagulation
- •International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless subject 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 subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
- •Creatinine clearance should be calculated per institutional standard.
- •Female subject of childbearing potential must have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- •Female subjects of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication (Reference Section 7.4). Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.
- •Male subjects must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.
排除标准
- •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. Subjects requiring systemic steroids are excluded from the trial. The use of physiologic doses of corticosteroids may be approved after discussion with the sponsor.
- •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 study Day 1 or who has not recovered (i.e., ≤ Grade 1 or 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 study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
- •Note: Subjects with ≤ Grade 2 neuropathy and alopecia are an exception to this criterion and may qualify for the study.
- •Note: If subject received major surgery, they must wait ≥ 3 weeks prior to starting study treatment. They must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
- •Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
- •Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
- •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). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- •Has an active infection requiring systemic therapy.
- •Patients that require supplemental oxygen are excluded.
- •Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- •Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- •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.
- •HIV+ positive patients are eligible if their CD4+ count ≥ 300/μL and they have an undetectable viral load. In addition, they must be currently receiving Highly Active Antiretroviral Therapy (HAART) and be under the care of an Infectious Diseases specialist.
- •Patients with hepatitis B and hepatitis C must be under the care of viral hepatitis expert consultant. Patients with hepatitis B are required to be treated with anti-HBV treatment (e.g., entecavir). Patients with hepatitis C need to have received prior and/or ongoing hepatitis C treatment.
- •Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
- •Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
研究组 & 干预措施
Pembrolizumab
Experimental
- Pembrolizumab is administered every 3 week intravenously
- Dosage to be determine by physician
干预措施: Pembrolizumab (Drug)
结局指标
主要结局
Overall Response Rate
时间窗: Disease was evaluated radiologically at baseline and every 3 cycles on treatment. The median follow-up was 12.6 months. All registered patients received at least one infusion of pembrolizumab and were treated for a median of 2 months (range: 0-23 months)
Overall response rate of pembrolizumab in metastatic anal cancer patients will be evaluated per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions. A complete response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
次要结局
- Incidence of Adverse Events to Evaluate the Safety and Tolerability of Pembrolizumab(Every 3 Weeks, from the time the informed consent is signed through 90 days following cessation of treatment "Every 3 Weeks, from the time the informed consent is signed through 30 days following cessation of treatment)
- PD-L1 Positive Response Rate(36 months)
- Overall Survival(36 months)
- Progression Free Survival(36 months)
研究者
James Cleary, MD, PhD
MD/PhD
Dana-Farber Cancer Institute
研究点 (4)
Loading locations...
相似试验
已完成
2 期
Surgery in Treating Patients With Early Stage Anal Canal or Perianal Cancer and HIV InfectionAnal Squamous Cell CarcinomaHIV InfectionStage 0 Anal Canal CancerStage I Anal Canal CancerNCT02437851AIDS Malignancy Consortium16
进行中（未招募）
2 期
Pembrolizumab in Treating Participants With Metastatic, Recurrent or Locally Advanced Cancer and Genomic InstabilityBRCA1 Gene MutationBRCA2 Gene MutationLocally Advanced Solid NeoplasmMetastatic Malignant Solid NeoplasmPOLD1 Gene MutationPOLE Gene MutationRecurrent Malignant Solid NeoplasmRecurrent Ovarian CarcinomaStage III Breast Cancer AJCC v7Stage III Ovarian Cancer AJCC v8Stage IIIA Breast Cancer AJCC v7Stage IIIA Ovarian Cancer AJCC v8Stage IIIB Breast Cancer AJCC v7Stage IIIB Ovarian Cancer AJCC v8Stage IIIC Breast Cancer AJCC v7Stage IIIC Ovarian Cancer AJCC v8Stage IV Breast Cancer AJCC v6 and v7Stage IV Ovarian Cancer AJCC v8Stage IVA Ovarian Cancer AJCC v8Stage IVB Ovarian Cancer AJCC v8NCT03428802Rutgers, The State University of New Jersey21
进行中（未招募）
2 期
Sunvozertinib (DZD9008) in Pretreated Lung Cancer Patients with EGFR Exon20 Insertion Mutation (WU-KONG6)Non-Small Cell Lung CancerNCT05712902Dizal Pharmaceuticals104
进行中（未招募）
2 期
Pembrolizumab in Treating Patients With Small Bowel Adenocarcinoma That is Metastatic or Locally Advanced and Cannot Be Removed by SurgeryMetastatic Small Intestinal AdenocarcinomaRecurrent Small Intestinal CarcinomaUnresectable Small Intestinal CarcinomaNCT02949219Academic and Community Cancer Research United41
Unknown
2 期
Study of Pomalidomide in Anal Cancer PrecursorsHigh Grade Squamous Intra-epithelial Lesion (HSIL)NCT03113942Kirby Institute26