Off-Label Treatment With Immune Checkpoint Inhibitor Blockade
2026年8月4日 更新者：Razelle Kurzrock, MD、Medical College of Wisconsin
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.
調査の概要
状態
まだ募集していません
条件
詳細な説明
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.
研究の種類
介入
入学 (推定)
231
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Medical College of Wisconsin Cancer Center Clinical Trials Office
- 電話番号：8900 866-680-0505
- メール：cccto@mcw.edu
研究場所
-
-
Wisconsin
-
Milwaukee、Wisconsin、アメリカ、53226
- Froedtert & the Medical College of Wisconsin
-
コンタクト：
- Razelle Kurzrock, MD
- 電話番号：414-955-2848
- メール：rkurzrock@mcw.edu
-
主任研究者：
- Razelle Kurzrock, MD
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Age ≥18 years.
- Zubrod Performance Status 0-2.
- 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.
Exclusion Criteria:
- 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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
Subjects will receive one of three ICI regimens, as prescribed by their treating medical oncologist.
|
|
実験的：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.
|
Subjects will receive one of three ICI regimens, as prescribed by their treating medical oncologist.
|
|
実験的：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.
|
Subjects will receive one of three ICI regimens, as prescribed by their treating medical oncologist.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Clinical response.
時間枠：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.
|
at least 6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Serious adverse events
時間枠：Up to 5 Years
|
The number of Grade ≥3 serious adverse events at least possibly related to ICIs during treatment, per NCI CTCAE v6.0.
|
Up to 5 Years
|
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Progression-Free Survival
時間枠：Up to 5 years
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Time from the start of off-label ICI treatment to the earliest date of documented progression, symptomatic deterioration, start of new anti-cancer therapy, or death from any cause.
Progression is assessed by the treating medical oncologist.
Patients alive without reported progression (including no evaluation) are censored at last contact.
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Up to 5 years
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Overall Survival
時間枠：Up to 5 years
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Time from the start of off-label ICI treatment to the date of death from any cause.
Patients last known to be alive are censored at the date of last contact.
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Up to 5 years
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Razelle Kurzrock, MD、Medical College of Wisconsin
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年11月1日
一次修了 (推定)
2032年11月1日
研究の完了 (推定)
2036年11月1日
試験登録日
最初に提出
2026年8月4日
QC基準を満たした最初の提出物
2026年8月4日
最初の投稿 (実際)
2026年8月10日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月10日
QC基準を満たした最後の更新が送信されました
2026年8月4日
最終確認日
2026年8月1日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
はい
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
はい
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。