Off-Label Treatment With Immune Checkpoint Inhibitor Blockade
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 231
- 试验地点
- 1
- 主要终点
- Clinical response.
研究概览
简要总结
This is a phase II therapeutic interventional clinical trial that will evaluate the efficacy, safety, and outcomes of off-label immune checkpoint blockade use across malignancies.
详细描述
Subjects will be in one of the three following groups (n=69 for each group), depending on the therapy administered:
- Treatment Group A: One or more off-label immune checkpoint inhibitor (ICI) (s) alone or with other on-label ICI(s).
- Treatment Group B: Off-label ICI(s) with targeted therapy.
- Treatment Group C: Off-label ICI(s) with other agents that are not targeted (including, but not limited to, chemotherapy, hormonal therapy, and immunotherapy other than ICIs) with or without targeted agents.
At least one ICI agent must be off-label, and no agent can be investigational; agents other than ICI can be on-label or off-label, but all have to be FDA-approved.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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.
- •Zubrod Performance Status 0-
- •Patients must have a documented malignancy where an off-label ICI is being considered by a physician.
- •Patients must have adequate organ function as specified below:
- •Absolute Neutrophil Count (ANC) ≥1,000/mcL
- •Platelets ≥75,000/mcL
- •Total Bilirubin ≤2.0 × upper limit of normal (ULN), unless the patient has changes consistent with Gilbert's Syndrome.
- •Alanine Aminotransferase (ALT) ≤3.0 × ULN
- •Serum Creatinine ≤2.0 × ULN or CrCl ≥50 mL/min as calculated by the Cockcroft-Gault equation.
- •5. Females of child-bearing potential must have a negative pregnancy test and must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from the time of informed consent, for the duration of study participation, and for 6 months following completion of therapy. Should a female patient become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception from the time of informed consent, for the duration of study participation, and 6 months after completion of administration.
- •NOTE: A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- •Has not undergone a hysterectomy or bilateral oophorectomy
- •Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for > 12 months)
- •Ability to understand a written informed consent document and the willingness to sign it.
- •Physician has verified coverage of the cost of the drug(s) via insurance, specialty pharmacy, patient assistance programs, or other means, as documented by physician/mid-level or nursing notes, pharmacist notes, or MCW/FH insurance approval.
排除标准
- •Uncontrolled illness, including symptomatic congestive heart failure (NYHA III/IV), unstable angina, or cardiac procedure within 2 weeks of start of ICI.
- •Concurrent therapy: use of other investigational (no FDA approval for any indication) anti-cancer agents within 14 days of registration.
- •Although other therapy is allowed together with the off-label ICI use as outlined in the protocol, before starting the study ICI off-label drug, the patient must be off other anti-cancer therapies for at least 2 weeks or 5 half-lives, whichever is shorter.
- •Major surgery (as defined by the treating medical oncologist) within two weeks of the start date of immunotherapy.
- •Other: pregnancy or lactation.
研究组 & 干预措施
One or more off-label ICI(s) alone or with other on-label ICI(s).
Study drug(s) will be administered at the discretion of the treating medical oncologist in accordance with the FDA-approved prescribing information for each agent and applicable institutional standards of care.
干预措施: One or more off-label ICIs alone or with other on-label ICI(s) (Drug)
Off-label ICI(s) with targeted therapy
Study drug(s) will be administered at the discretion of the treating medical oncologist in accordance with the FDA-approved prescribing information for each agent and applicable institutional standards of care.
干预措施: Off-label ICI(s) with targeted therapy (Drug)
Off-label ICI(s) with other agents that are not targeted with or without targeted agents.
Not targeted includes, but is not limited to chemotherapy, hormonal therapy, immunotherapy other than ICIs. Study drug(s) will be administered at the discretion of the treating medical oncologist in accordance with the FDA-approved prescribing information for each agent and applicable institutional standards of care.
干预措施: off-label ICI(s) with other agents that are not targeted (including, but not limited to, chemotherapy, hormonal therapy, immunotherapy other than ICIs) with or without targeted agents (Drug)
结局指标
主要结局
Clinical response.
时间窗: at least 6 months
The proportion of subjects who achieve complete response, partial response, or stable disease of at least 6 months, as evaluated by a physician investigator, who can use RECIST v1.1 and iRECIST. For non-solid malignancies, the standard evaluation criteria for that malignancy will be used.
次要结局
- Serious adverse events(Up to 5 Years)
- Progression-Free Survival(Up to 5 years)
- Overall Survival(Up to 5 years)
研究者
Razelle Kurzrock, MD
Associate Faculty Director
Medical College of Wisconsin