皮膚がん患者に対する放射線療法とセミプリマブの研究
放射線療法とCeMiPlimAbの第II相、多施設、単腕臨床試験：局所進行切除不能皮膚扁平上皮癌に対するRwlc免疫療法：RAMPART
The purpose of the study is to see if the combination of radiation therapy and cemiplimab immunotherapy is an effective treatment for people with locally advanced, unresectable CSCC.
調査の概要
状態
介入・治療
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
-
-
Colorado
-
Aurora、Colorado、アメリカ、80045
- University of Colorado (Data Collection Only)
-
-
Florida
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Tampa、Florida、アメリカ、33612
- Moffitt Cancer Center (Data Collection Only)
-
-
New Jersey
-
Basking Ridge、New Jersey、アメリカ、07920
- Memorial Sloan Kettering Cancer Center at Basking Ridge (All Protocol Activities)
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Middletown、New Jersey、アメリカ、07748
- Memorial Sloan Kettering Monmouth (All Protocol Activities)
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Montvale、New Jersey、アメリカ、07645
- Memorial Sloan Kettering Bergen (All protocol activities)
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New York
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Commack、New York、アメリカ、11725
- Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities)
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Harrison、New York、アメリカ、10604
- Memorial Sloan Kettering Westchester (All Protocol Activities)
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New York、New York、アメリカ、10065
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)
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Rockville Centre、New York、アメリカ、11553
- Memorial Sloan Kettering Nassau (All protocol activities)
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Ohio
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Cleveland、Ohio、アメリカ、44195
- Cleveland Clinic (Data Collection Only)
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19111
- Fox Chase Cancer Center (Data Collection Only)
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South Carolina
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Charleston、South Carolina、アメリカ、29425
- Medical University of South Carolina
-
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Washington
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Seattle、Washington、アメリカ、98109
- University of Washington (Data Collection Only)
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
-
Biopsy proven cutaneous squamous cell carcinoma which is locally advanced
- Mixed histology tumors that are predominantly squamous cell carcinoma are eligible
- Locally advanced primary tumor is T3-T4 and/or N+ by AJCC and/or UICC 8th edition clinical criteria
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T3-T4 primary tumor characteristics noted below:
- Non-eyelid tumor >4 cm in maximum dimension or with bone erosion or invasion, perineural invasion of nerve 0.1 mm or larger, or invasion beyond subcutaneous fat or >6 mm from granular layer of adjacent normal epidermis
- Eyelid tumor >2 cm or invading adjacent ocular, orbital or facial structures
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≥18 years old
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Unresectable or medically inoperable according to local multidisciplinary consensus for reasons such as:
- Tumor or regional lymph node metastases that has recurred despite ≥2 prior surgical procedures, with another curative resection unlikely
- Tumor or nodal disease with significant local invasion that precludes complete resection
- Tumor or nodal disease in anatomically challenging area where surgery may result in significant disfigurement or dysfunction (amputation of nose, ear, eye, digit, limb, etc)
- Medical contraindication to surgery
- Patient refusal of surgery due to anticipate morbidity
-
ECOG ≤2
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Adequate bone marrow and metabolic function (by blood tests)
- Total bilirubin ≤1.5 x upper limit of normal
- Aspirate aminotransferase (AST) ≤3 x upper limit of normal
- Alanine aminotransferase (ALT) ≤3 x upper limit of normal
- Alkaline phosphatase ≤2.5 x upper limit of normal
- Serum creatinine ≤1.5 x upper limit of normal or estimated creatinine clearance >30 mL/min according to Cockcroft-Gault formula
- Hemoglobin >9 g/dL
- Absolute neutrophil count ≥1.5 x10^9/L
- Platelet count ≥75 x10^9/L
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Able to provide informed consent
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Acceptable candidate for curative intent radiotherapy and Cemiplimab immunotherapy, in opinion of radiation and medical oncologist, respectively
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Life expectancy >18 months
Exclusion Criteria:
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Primary tumor originating on the mucosal (non-hair bearing) lip or nose, anogenital (penis, scrotum, vulva, perianal) area
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Iatrogenic immunosuppression (>prednisone 10 mg/day or equivalent within 14 days of initiation of treatment)
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Women of child bearing potential unwilling or unable to use effective contraception while receiving treatment with cemiplimab and for 4 months thereafter
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Distant metastases
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Clinically significant autoimmune disease that requires iatrogenic immunosuppression
o For example, severe rheumatoid arthritis requiring disease modifying antirheumatic drugs, such as methotrexate
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Current or previous hematopoietic malignancy (leukemia, lymphoma)
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Prior allogeneic transplant of solid organ or bone marrow
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Concurrent malignancies with >10% risk of metastasis or death within 2 years
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Prior aPD1 immunotherapy or PI3Kδ inhibitor use
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Prior radiotherapy for the cutaneous squamous cell carcinoma requiring treatment
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Other ongoing cancer therapy
o Adjuvant endocrine therapy is permitted for patients with prostate or breast cancer
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Uncontrolled HIV or infectious hepatitis (viral load detectable in patient with known infection)
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Pregnancy or breastfeeding
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Comorbid or diagnostic abnormalities within the last year that would interfere with interpretation of study results
研究計画
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：なし
- 介入モデル：単一グループの割り当て
- 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：Participants with locally advanced, unresectable cutaneous squamous cell carcinoma/CSCC
Participants have locally advanced, unresectable cutaneous squamous cell carcinoma/CSCC |
Participants will undergo baseline imaging, followed by two doses of neoadjuvant cemiplimab at a dose of 350 mg intravenously over 30 minutes every 3 weeks (+/-3 days). Then, participants will receive concurrent cemiplimab 350 mg intravenously over 30 minutes every 3 weeks (+/-3 days) concurrently with RT to 70 Gy in 35 fractions over 7 weeks. Thereafter, participants will receive 38 weeks of cemiplimab 350 mg intravenously over 30 minutes every 3 weeks (+/-3 days) for a cumulative total of 12 months of cemiplimab. Participants will receive radiotherapy to 70 Gy in 35 fractions over 7 weeks concurrently with cemiplimab |
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 |
|---|---|---|
|
Event Free Survival
時間枠：18 months
|
The primary endpoint for this study is event free survival at 18 months (week 78 +/- 3 weeks) after starting cemiplimab. |
18 months
|
協力者と研究者
捜査官
- 主任研究者：Christopher Barker, MD、Memorial Sloan Kettering Cancer Center
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 22-090
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?
IPD プランの説明
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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
米国FDA規制機器製品の研究
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。