NCT04116073已完成2 期
A Phase II Trial of INCMGA00012 in Patients With Previously Treated Unresectable or Metastatic Adenosquamous Pancreatic or Ampullary Cancer
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2020年4月9日最近更新:
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
- 25
- 试验地点
- 1
- 主要终点
- Disease Control Rate (DCR) at 4 Months Using RECIST 1.1
研究概览
简要总结
Phase 2 study to evaluate the clinical activity of INCMGA00012 in patients with Unresectable or metastatic Adenosquamous Pancreatic or Ampullary Cancer.
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
- •Age ≥18 years.
- •Have histologically or cytologically - proven adenosquamous carcinoma of the pancreas or ampulla.
- •Has unresectable or metastatic measurable disease.
- •Has received (or been intolerant to or ineligible for) at least 1 prior line of cytotoxic chemotherapy and received no more than 2 prior systemic treatments.
- •Presence of at least one lesion with measurable disease.
- •Accept to have a tumor biopsy of an accessible lesion at baseline and on treatment.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or
- •If HIV-positive, then all of the following criteria must also be met: cluster of differentiation (CD) 4+ count ≥ 350/μL, undetectable viral load, and receiving highly active antiretroviral therapy.
- •Life expectancy of greater than 3 months.
- •Patients must have adequate organ and marrow function defined by study-specified laboratory tests prior to initial study drug.
- •Woman of childbearing potential must have a negative pregnancy test and follow contraceptive guidelines as defined per protocol.
- •Men must use acceptable form of birth control while on study.
- •Ability to understand and willingness to sign a written informed consent document.
- •Exclusion Criteria
- •Known history or evidence of brain metastases.
- •Has had chemotherapy, radiation, or biological cancer therapy within 14 days prior to the first dose of study drug.
- •Has received an investigational agent or used an investigational device within 28 days of the first dose of study drug.
- •Expected to require any other form of systemic or localized antineoplastic therapy while on study.
- •Has had major surgery within 28 days of dosing of investigational agent, excluding minor procedures.
- •Has received a live vaccine within 28 days prior to the first dose of study drug.
- •Prior treatment with immunotherapy agents (including, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, anti-OX40 and LAG-3 antibodies)
- •Have used any systemic steroids within 14 days of study treatment.
- •Hypersensitivity reaction to any monoclonal antibody.
- •Evidence of clinical or radiographic ascites.
- •Have clinically significant and/or malignant pleural effusion.
- •Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness/social situations that would limit compliance with study requirements.
- •History of autoimmune disease requiring systemic immunosuppression within the last 2 years.
- •Presence of any tissue or organ allograft, regardless of need for immunosuppression, including corneal allograft. Patients with a history of allogeneic hematopoeitic stem cell transplant will be excluded.
- •All toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must have resolved to a grade 1 or baseline before administration of study drug.
- •Infection with Hepatitis A, B or C.
- •Patient has a pulse oximetry of <92% on room air.
- •Patient is on supplemental home oxygen.
- •Has an unhealed surgical wound or ulcer, or a bone fracture considered non-healing.
- •Patient has clinically significant heart disease.
- •Patient is, at the time of signing informed consent, a regular user (including "recreational use") of any illicit drugs or other substance abuse.
- •Unwilling or unable to follow the study schedule for any reason.
- •Patient has history of non-infectious pneumonitis.
- •Serum albumin level less than 2.8 g/dL.
排除标准
- 未提供
研究组 & 干预措施
INCMGA00012 (PD-1 antibody)
Experimental
All participants received the interventional study drug; INCMGA00012.
干预措施: INCMGA00012 (PD-1 antibody) (Drug)
结局指标
主要结局
Disease Control Rate (DCR) at 4 Months Using RECIST 1.1
时间窗: 4 months
Disease control rate (DCR) is defined as the proportion of subjects with complete response, partial response and stable disease based on RECIST 1.1 criteria. CR = disappearance of all target lesions, PR is =\>30% decrease in sum of diameters of target lesions. SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Subjects who discontinue due to toxicity prior to post-baseline tumor assessments will be evaluable and considered treatment failures.
次要结局
- Objective Response Rate (ORR) Using RECIST 1.1.(4 years)
- Progression-free Survival (PFS)(34 months)
- Grade 3 and Higher Study Drug-related Toxicities.(26 months)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
A Study of INCMGA00012 in Participants With Selected Solid Tumors (POD1UM-203)Metastatic Non-small Cell Lung CancerLocally Advanced Urothelial CancerMetastatic Urothelial CancerUnresectable MelanomaMetastatic MelanomaLocally Advanced Renal Cell CarcinomaMetastatic Clear-Cell Renal Cell CarcinomaNCT03679767Incyte Corporation121
已完成
2 期
A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma (POD1UM-201)Metastatic Merkel Cell CarcinomaNCT03599713Incyte Corporation107
已完成
2 期
A Study of INCMGA00012 in Squamous Carcinoma of the Anal Canal Following Platinum-Based Chemotherapy (POD1UM-202)Squamous Cell Carcinoma of Anal CanalNCT03597295Incyte Corporation94
进行中（未招募）
2 期
INCMGA00012 and Pelareorep for the Treatment of Metastatic Triple Negative Breast Cancer, IRENE StudyAnatomic Stage IV Breast Cancer AJCC v8Locally Advanced Breast CarcinomaMetastatic Triple-Negative Breast CarcinomaPrognostic Stage IV Breast Cancer AJCC v8Triple-negative Breast CancerNCT04445844Mridula George, MD25
已完成
1 期
INCMGA00012 in Combination With Other Therapies in Patients With Advanced Solid TumorsUnresectable or Metastatic Solid TumorsNCT03589651Incyte Corporation83