Adjuvant/Neoadjuvant Immunotherapy in Melanoma Based on Serial Plasma ctDNA Monitoring
The purpose of the study is to see if periodic (serial) blood-based testing of ctDNA (circulating tumor DNA) while receiving study treatment with study drug therapy for advanced melanoma (skin cancer) can be used to decide the best plan for care during and after initial study drug treatment.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Anjana Menon
- 電話番号：813-745-5537
- メール：Anjana.Menon@moffitt.org
研究場所
-
-
Florida
-
Tampa、Florida、アメリカ、33612
- 募集
- Moffitt Cancer Center
-
副調査官：
- Ahmad Tarhini, MD
-
副調査官：
- Nikhil Khushalani, MD
-
副調査官：
- Andrew Brohl, MD
-
主任研究者：
- Zeynep Eroglu, MD
-
副調査官：
- Edith Abraham, MD
-
副調査官：
- Lilit Karapetyan, MD
-
副調査官：
- Joseph Markowitz, MD
-
-
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:
- Age ≥18 years
- Histologically confirmed melanoma (excluding uveal melanoma)
- Neoadjuvant Cohort: Surgically resectable AJCC 8th edition Stage III or Stage IV melanoma
- Adjuvant Cohort: Completely resected AJCC 8th edition Stage IIB, IIC, III, or IV melanoma
- ECOG Performance Status ≤2
- Adequate organ function: AST and ALT ≤5 × upper limit of normal (ULN) and Creatinine ≤2 × ULN.
- Baseline imaging obtained within 28 days prior to treatment initiation
- Negative pregnancy test for women of childbearing potential
- Ability to understand and sign informed consent
Exclusion Criteria:
- Prior anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 therapy within 1 year before enrollment
- Contraindication to nivolumab and/or ipilimumab
- Active autoimmune disease requiring systemic immunosuppressive therapy
- Concurrent malignancy requiring active treatment that could interfere with study treatment or assessments
- Unresectable disease
- Uveal melanoma
- Any medical, psychiatric, or social condition that would interfere with protocol compliance or study participation
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：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：Neoadjuvant cohort
Patients with resectable stage III/IV melanoma eligible for neoadjuvant treatment will be enrolled. Patient cases will be reviewed with the surgery team to confirm surgical resectability prior to enrollment and CT imaging will be obtained at baseline, as per standard of care. |
Administered intravenously as neoadjuvant and/or adjuvant therapy for melanoma according to protocol-defined dosing schedules. Administered intravenously in combination with nivolumab in participants meeting ctDNA-defined criteria for treatment escalation. Tumor-informed circulating tumor DNA assay performed on serial plasma samples to evaluate molecular residual disease and guide treatment adaptation. |
|
実験的：Adjuvant cohort
Patients who already underwent complete surgical resection of stage IIB/IIC/III/IV melanoma (and did not receive prior neoadjuvant treatment.) All patients in this cohort must be within 10 weeks of surgery and have CT scans post-surgery prior to study enrollment to confirm they are radiographically disease-free. Following study enrollment, all patients will have the first ctDNA analyses done within 12 weeks of date of surgery. |
Administered intravenously as neoadjuvant and/or adjuvant therapy for melanoma according to protocol-defined dosing schedules. Administered intravenously in combination with nivolumab in participants meeting ctDNA-defined criteria for treatment escalation. Tumor-informed circulating tumor DNA assay performed on serial plasma samples to evaluate molecular residual disease and guide treatment adaptation. |
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 (EFS) in the Neoadjuvant Cohort
時間枠：Up to 5 Years
|
Defined as the time from initiation of study treatment to disease progression precluding surgery, melanoma recurrence, progression, or death from any cause. |
Up to 5 Years
|
|
Relapse-Free Survival (RFS) in the Adjuvant Cohort
時間枠：Up to 5 years
|
Defined as the time from initiation of adjuvant treatment to melanoma recurrence or death from any cause. |
Up to 5 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pathologic Response Rate (Neoadjuvant Cohort)
時間枠：Up to 12 weeks
|
Proportion of participants achieving pathologic response in the surgical specimen following neoadjuvant treatment, including pathologic complete response (pCR) and major pathologic response (MPR). |
Up to 12 weeks
|
|
Objective Response Rate (ORR) by RECIST v1.1 (Neoadjuvant Cohort)
時間枠：Up to 12 weeks
|
Proportion of participants achieving a complete response or partial response according to RECIST version 1.1 based on radiographic assessments performed during neoadjuvant treatment. |
Up to 12 weeks
|
|
Relapse With Undetectable ctDNA
時間枠：Up to 5 years
|
Frequency of participants who maintain undetectable circulating tumor DNA (ctDNA) during serial monitoring and subsequently experience clinical and/or radiographic melanoma relapse. |
Up to 5 years
|
協力者と研究者
捜査官
- 主任研究者：Zeynep Eroglu, MD、Moffitt Cancer Center
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
追加の関連 MeSH 用語
その他の研究ID番号
- MCC-23763
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
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